CRC

CRC CERTIFICATION GUIDE

Certification
Handbook

Academy of Clinical Research Professionals | 500 Montgomery St., Suite 800 | Alexandria, VA 22314 | www.acrpnet.org

Academy of Clinical Research Professionals

500 Montgomery St., Suite 800
Alexandria, VA 22314
www.acrpnet.org

Certified Clinical Research Coordinator (CCRC)

Program Handbook 2013
Exam Dates
February 28 March 16, 2013

Certification Checklist
Before you begin the Certification application process, be sure to:
1. Read the entire CRC Certification Handbook
The CRC Certification Handbook contains all the information you need to know about the exam, so
please be sure to read it in full. You are required to attest to having read this information when submitting
an exam application.
2. Verify Your Membership Status
In order to take advantage of the reduced member rate, you must be an active member before beginning
the application process. Log in to www.acrpnet.org to verify your member status or to join before
applying for your exam. Once you join, log out of www.acrpnet.org, log back in, and begin the
application process. If you do not wish to become an ACRP member, you may proceed with the
application process at the non-member rate.
3. Have All Application Documentation Ready
All supporting documentation must be submitted with the application in order for your application to be

considered. Documentation required for CCRC applicants includes:

CV or resume
Job description

Note: File sizes must be less than 5 megabytes for online applications.

4. Submit Your Application

Submit your application either online or via a printable application form (not both, to avoid duplicate
charges). All required elements (application, supporting documentation, and full payment) must be
submitted together. After you submit your application, if you submitted it online, you will receive an
automatic e-mail confirmation. Please allow up to 10 business days for confirmation of mailed or faxed
applications. All applications undergo a thorough eligibility review process. Please allow up to three
weeks for your eligibility e-mail notification.
To ensure you receive this and other important Certification-related notifications, add www.acrpnet.org
to your safe senders list (contact your IT department for instructions).

Table of Contents
Certification Checklist ................................................................................................................................ 1
Quick Reference Questions ....................................................................................................................... 4
Quick Reference Links ............................................................................................................................... 6

Welcome to the Certified Clinical Research Coordinator (CCRC ) Program ....................................... 7

What is Certification? ................................................................................................................................ 7

Top 10 Reasons to be a CCRC .............................................................................................................. 7

About the Academy of Clinical Research Professionals .......................................................................... 8

Eligibility for the CCRC Program ............................................................................................................ 9

Certification Eligibility Requirements ........................................................................................................ 9
CRC Essential Duties ............................................................................................................................... 9
*Clinical Research Education Programs................................................................................................. 10

Application for the CCRC Program ....................................................................................................... 11

Application Form ..................................................................................................................................... 12
Supporting Documents ........................................................................................................................... 12
Payment and Fees.................................................................................................................................. 12
Submitting the Application ...................................................................................................................... 13
Eligibility Review ...................................................................................................................................... 14
Confirmation of Eligibility and Testing Information ................................................................................. 14
Ineligibility Decision Appeals Process .................................................................................................... 15
Exam Scheduling ...................................................................................................................................... 15
Services for People with Disabilities ....................................................................................................... 16
Rescheduling Exam Within Same Exam Cycle ...................................................................................... 16
Transfer to Next Exam Window .............................................................................................................. 17
Reactivation Form (for Transferred Exams) ........................................................................................... 17
Cancellations .......................................................................................................................................... 17
Emergencies ........................................................................................................................................... 18
Refunds .................................................................................................................................................. 18
Prepare to Take the Exam ........................................................................................................................ 19
Written Exam .......................................................................................................................................... 19
Language ................................................................................................................................................ 19
What is Covered on the Exam? .............................................................................................................. 19
Detailed Content Outline (DCO) ............................................................................................................. 20
Study Texts ............................................................................................................................................. 24
ACRP Online Preparation Support ......................................................................................................... 26

Preparing for the CCRC Exam.............................................................................................................. 27

Steps to Preparing for the CCRC Exam ............................................................................................... 27

Further Study Tips .................................................................................................................................. 28
Test-Taking Strategies............................................................................................................................ 28
Taking the Exam ....................................................................................................................................... 29
Identification ............................................................................................................................................ 29
Time ........................................................................................................................................................ 29
Test Center Guidelines ........................................................................................................................... 30
Exam Security......................................................................................................................................... 30
Exam Results .......................................................................................................................................... 30
Exam Scores ............................................................................................................................................. 31
Scaled Scores and Score-Reporting FAQs ............................................................................................ 32
How are Certification Exams Developed? ............................................................................................. 32
Reliability Measurements ....................................................................................................................... 33
Duplicate Certificates ............................................................................................................................... 33
Maintenance of Certification ................................................................................................................... 34
Requirements ......................................................................................................................................... 34
Other Pertinent Policies and Procedures .............................................................................................. 35
Nondiscrimination Policy ........................................................................................................................ 35
Confidentiality ......................................................................................................................................... 35
Verification of Credentials ....................................................................................................................... 35
Certification Mark Use ............................................................................................................................ 35
Revocation of Certification ...................................................................................................................... 36
Policy on Appeal of Denial of Eligibility................................................................................................... 36
Discipline and Complaints Policy ............................................................................................................ 36
Frequently Asked Questions (FAQs) ...................................................................................................... 37
APPENDICES ............................................................................................................................................ 39
Appendix 1 Sample CV ....................................................................................................................... 40
Appendix 2 Request for Special Accommodations ............................................................................. 41
Appendix 3 Request to Transfer Application ....................................................................................... 42
Appendix 4 Emergency Cancellation Request .................................................................................... 43
Appendix 5 Duplicate Certificate Printing Request.............................................................................. 44

Quick Reference Questions

Question type determines who needs to be contacted. Please refer to chart for common examples:
Question or Concern
Contact Whom?
Contact Information

Exam Registration
ACRP Member Services
The Academy
The Academy

[email protected]
[email protected]
[email protected]

Prometric website

www.prometric.com/ACRP

ACRP websiteFees
calculator
Prometric

www.acrpnet.org/popups/c
rc-fee-calculator.html
800-853-6769
OR
www.prometric.com/ACRP

Exam rescheduling 16 to 29 days

prior to exam

Prometric - $25 fee

Exam rescheduling 5 to 15 days prior

to exam

Prometric - $50 fee

800-853-6769
OR
www.prometric.com/ACRP
800-853-6769
OR
www.prometric.com/ACRP

Exam application received?

Didnt receive notification of eligibility
What is my Prometric testing ID
number?
How can I locate a test site?
How much are exam fees?
Exam rescheduling more than 29
days prior to exam

No rescheduling permitted less than 5

days prior to exam date

Exam Transfers/Cancellations
Exam transfers/cancellation
more than 29 days prior to exam

Exam transfers/cancellation
16 to 29 days prior to scheduled exam

Exam transfers/cancellation
5 to 15 days prior to scheduled exam
NOTE: No cancellations are
permitted fewer than 5 days prior to
the scheduled exam.

Both: Prometric FIRST to

cancel appointment, then
notify the Academy via e-mail
(Use Exam Transfer Request
Form if transferring)
Both: Prometric FIRST to pay
$25 change fee, then notify the
Academy via e-mail
(Use Exam Transfer Request
Form if transferring)

Prometric: 800-853-6769
www.prometric.com/ACRP

Both: Prometric FIRST to pay

$50 change fee, then notify the
Academy via e-mail
NOTE: No refunds permitted
fewer than 5 days prior to
scheduled exam.
(Use Exam Transfer Request
Form if transferring)

Prometric: 800-853-6769
www.prometric.com/ACRP

E-mail the Academy:

[email protected]
Prometric: 800-853-6769
www.prometric.com/ACRP
E-mail the Academy:
[email protected]

E-mail the Academy:

[email protected]

Post Exam Questions

Change of contact information

ACRP Member Services

[email protected]

General Contact Information

Prometric Member Services
To report issues with your Prometric
experience
Academy of Clinical Research
Professionals (the Academy)

Prometric
Prometric

800-481-6525
800-853-6769

Certification Department

500 Montgomery Street

Suite 800
Alexandria VA 22314-1560
Phone: 703-254-8100
Fax: 703-254-8101
E-mail:
[email protected]

Quick Reference Links

Below are some quick reference links used during the Certification process. Please review the full contents of this
Handbook for complete details.

Application

Online and Printable: www.acrpnet.org/crccertification

Forms

Exam Transfer Request Form: www.acrpnet.org/PDF/TransferRequestForm.pdf

Transfer Terms and Conditions: www.acrpnet.org/sp/Terms-Conditions-for-Certification-ApplicationTransfer.aspx
Emergency Cancellations: www.acrpnet.org/PDF/MissedExamEmergencyForm.pdf
Special Accommodations for Taking Exam:
www.acrpnet.org/PDF/SpecialAccommodationsRequestForm.pdf

Exam Content

Declaration of Helsinki (World Medical Association):

www.wma.net/en/20activities/10ethics/10helsinki/index.html
International Conference on Harmonization (ICH) Guidelines: www.ich.org

Optional Exam Preparation Materials Available for Purchase: www.acrpnet.org/examprep

Exam Practice Exercise

Exam Preparation Guide
Exam Review Bundle

Taking the Exam (Prometric): http://prometric.com/ACRP

Locate a Test Center

Scheduling Your Exam
Exam Appointment Confirmation
Reschedule Exam Appointment

CRC Fees Calculator: www.acrpnet.org/popups/crc-fee-calculator.html

Welcome to the Certified Clinical Research Coordinator (CCRC)

Program
The Academy of Clinical Research Professionals (the Academy) would like to congratulate you on your decision
to pursue Certification in your chosen field of work. As a professional in clinical research, you deserve to be
recognized and appreciated for what you do, and like most professionals, you want to become better at it. You
look for opportunities for ongoing professional development and practical ways to evaluate your own work that will

help you develop as a professional. This is one reason the Academys CCRC credential was created.

What is Certification?
Certification is a voluntary process to recognize individuals for meeting professional standards set by an impartial
third party. The Academy Certification is the formal recognition of clinical research professionals who have met
eligibility requirements and demonstrated proficiency of specific knowledge and jobrelated skills by passing a
standardized exam.
Academy Certification programs are the only ones in clinical research accredited by the National Commission for
Certifying Agencies (NCCA), which sets independent standards for the development and operation of certification
programs. NCCA accreditation assures the validity and credibility of the process. For more information on the
NCCA, please visit www.credentialingexcellence.org.

Top 10 Reasons to be a CCRC

1. Establishes credibility. Academy Certification serves as an impartial, thirdparty endorsement of your
knowledge and experience against international standards in clinical research. It adds to your credibility as a
clinical researcher and sets you apart from other professionals.
2. Improves career opportunities and advancement. Academy Certification can give you an advantage when
being considered for a promotion or other career opportunities. It clearly identifies you as an employee who
has demonstrated proficiency of internationally-accepted clinical research principles, techniques, and
application of best practices onthejob.
3. Increases onthejob responsibilities. Academy Certification is a clear indicator of your willingness to invest
in your own professional development. Certified professionals are aware of the constantly changing
environment within their profession, and possess the desire to anticipate and respond to change.
4. Enhances skills and knowledge. Achieving Certification through the Academy requires training, studying,
and keeping uptodate with changes in the profession. Becoming certified showcases your individual mastery
by confirming proficiency in the field. Academy Certification also requires Maintenance of Certification every
two years, to ensure you stay informed and continue to develop as a clinical research professional.
5. Fosters earnings potential. Many clinical research professionals who have become Academy certificants
experience salary and wage increases and/or bonuses based on their Certification status. In addition,
Academy certificants are in high demand and aggressively recruited.
6. Demonstrates engagement. Earning Certification through the Academy shows your peers, supervisors, and
trial subjects your commitment to your chosen career and the clinical research profession at large, as well as
your ability to perform to set standards.
7. Strengthens the professions image. The Academys Certification program seeks to grow, promote, and
develop certified professionals who can serve as role models for good clinical practice (GCP) in the clinical
research field.

8. Validates accomplishment. Academy Certification is a reflection of personal achievement because you have
validated your skill set, specific to the job role you perform, by meeting internationally recognized standards
set forth via International Conference on Harmonization (ICH) Guidelines.
9. Builds selfesteem. Certification through the Academy is a step toward defining yourself beyond a job
description or academic degree, while gaining a sense of personal satisfaction.
10. Enhances recognition. As an Academy certificant, you can expect increased acknowledgment from your
peers for taking that extra step in your professional career.

About the Academy of Clinical Research Professionals

Founded in 2006 as an affiliate of the Association of Clinical Research Professionals (ACRP), the Academy of
Clinical Research Professionals (the Academy) is the certifying body responsible for the governance and
administration of the only job rolespecific, accredited credentials available to clinical research professionals.
The Academys Board of Trustees, elected by current certificants in good standing, is responsible for awarding

the CCRC credential and for establishing eligibility criteria, examination content, passing scores, and
Maintenance of Certification requirements.

The Certified Clinical Research Coordinator (CCRC ) credential was first awarded in 1992. The program is open
to any eligible clinical research professional, regardless of membership affiliation. The program consists of an
assessment of an eligible candidates professional experience and mastery of job-specific clinical research
principles and techniques, as measured by a written examination and periodic demonstration of continued
competence through the Maintenance of Certification process.
The Academy adheres to the highest standards by benchmarking its practices against standards set for
certification programs. The National Commission for Certifying Agencies (NCCA) of the National Organization for
Competency Assurance (NOCA) has established criteria for certification agencies, and in 2010, the Academys

CCRC and CCRA programs received NCCA accreditation.

Certified Clinical Research Coordinator (CCRC) Program

From Regional to International Standards

1992
CCRC
(North America)

2002
CCRC
(Europe)

2004
CCRC
(Asia)

2010
2013
ICH-based Exams
Over 17,000
NCCA-Accredited
550 Test Sites Added CRCs Have
Become
Computer-Based
Certified
Testing

What is Required for Certification?

In order to achieve Certification, all applicants must meet the Eligibility Requirements and pass the Written
Exam.
The applicant should determine his/her own eligibility before submitting an application to the program. Upon
submission of a complete application, an eligibility review is conducted by the Academy. The candidate is then
notified of the eligibility review outcome via e-mail. All eligible candidates must then schedule an appointment to
take the exam.
Candidates who meet the eligibility requirements and pass the exam will be certified as having met the Academy

standards for becoming a CCRC , as adopted by the Academy. Maintenance of Certification of ones Certification
is required every two (2) years for continuance of the designation.

Meet Eligibility
Requirements

Eligibility
Schedule
Prepare
Eligibility forReview
the CCRCExam
Program
Apply

Pass
Exam

A clinical research coordinator (CRC), regardless of job title, works at a clinical research site under the immediate
direction of a principal investigator, whose research activities are conducted under good clinical practice (GCP)
guidelines

Certification Eligibility Requirements

In order to be deemed Eligible to take the CCRC exam, applicants for the CCRC credential must be able to
provide evidence through a job description, detailed CV or other documentation that they:

Perform all of the CCRC Essential Duties as detailed below for a required minimum number of hours.
Hours performing the CCRC Essential Duties can include hours documented up to the date of the exam
and/or through previous employment. The required number of hours is dependent upon ones
educational background.

CRC Essential Duties

As defined by the Academy, and determined through ACRPs 2010 Job Analysis Survey, clinical research
coordinators who are eligible for CRC Certification must document cumulative performance of each of the
following Essential Duties during the dates of employment listed on the application:

Document adverse events;

Prepare or review documents submitted to the institutional review board (IRB);
Protocol review or study procedures planning;
Participate in conducting subject visits;
Maintain source documents;
Prepare for and participate in study visits with monitor, sponsor, auditors, etc.;
Participate in consent process.

CCRC Eligibility Requirements

At least one of the Eligibility Requirement options below should be met before applying for the CCRC
program.
Education

Option 1

Option 2

Minimum Hours
Performing
Essential Duties

Required Documentation
of Performed
Essential Duties

3,000 hours*

Detailed CV/resume AND

Associates or Bachelors degree (or

higher) OR
Registered Nurse (RN)

Other, such as LPN, LVN, Medical

Assistant, Lab Technician

Job Description

Detailed CV/Resume
4,500 hours*
AND

OR
Job Description

High School diploma

*Clinical Research Education Programs

The Academy considers applicants who have completed a clinical research education program that meets the
following standards to have achieved a valid substitute for 1,500 hours of professional experience.
Acceptable programs must:

Be at least 216 contact hours in length and

Cover content that substantially maps to the topics found on the current CRC Detailed Content Outline
(DCO) and

Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation

(CHEA). A list of recognized accrediting agencies can be found from the CHEA website:
www.chea.org/search.

10

If an applicant submits an application using an educational program as a substitute for 1,500 hours of CRC work
experience, then the following information must be included on the applicants CV (see Appendix 1 for a sample
CV) and a certificate of completion must also be submitted:

Name of school
City and country in which the school is located
Program title
Name of organization that accredits the institution providing the program
Dates attended (From-To)

Meet Eligibility
Requirements

Apply

Eligibility
Review

Schedule
Exam

Prepare

Take
Exam

Application for the CCRC Program

Application Deadline: January 21, 2013*
Late Applications are accepted with a Late Fee through February 4, 2013.
*Received, not postmarked
Once an applicant has carefully determined he/she meets the eligibility requirements, the application process can
begin. A complete application has three (3) major components:
1. CRC Application Form
2. Supporting documentscurriculum vitae (CV)/resume and job description
3. Full payment
The Application Form, supporting documents, and full payment must be complete and submitted together by the
due date in order for the candidate to be considered for the next step (the eligibility review to take the written
exam).

Application

Supporting
Documents

Payment

11

Application
Ready to
Submit

Application Form
An online and printable Application Form is available on the ACRP website at www.acrpnet.org/crccertification.
Using the online application is recommended, as it is received immediately for eligibility review. Completed copies
are not available therefore, it is recommended for the applicant to take a screen shot if one is needed. Have all
documentation and employment information ready so that data in the online application is captured and does not
time out.
Applicants submitting a check or bank transfer must submit the printable version of the application. If completing
the printable application, make sure the application is received (not postmarked) by the Academy by the deadline
to avoid the late fee.
Have the following information ready before applying:

Work Experience
1. Employer(s) - list only positions supporting experience performing the essential functions of a CRC.
2. Supervisor Name
3. Address
4. Phone
5. Supervisor Email
6. Start and End Date of Employment (consistent with CV/resume)
7. Average Hours Worked per Week (enter an exact number amount, i.e. 45)
The Academy has the right to verify qualifications. By submitting an application, applicants consent to and
authorize the Academy to verify the applicants academic and employment records. The Academy reserves the
right to request backup documentation to substantiate the reported information at any time during the
application process and/or once the candidate has been certified.

Supporting Documents
Supporting documentation is required for the education and work experience listed in the application. A detailed
CV or resume is required, which must include employers, corresponding employment dates, and a description of
the CRC essential duties performed by the applicant. Only positions in which the applicant has performed the
essential CRC job functions are considered, regardless of the job title. No other positions or study participation
listings will be considered.

Job Description
A job description is a required document that further details the tasks performed for each relevant position. It may
be employer- or applicant-created, and should list only the specific functions and tasks performed that support
ones eligibility.

Certificate/Transcript
Candidates who are substituting the completion of a clinical research education program for work experience are
required to provide a Certificate of Completion or transcript. (See Clinical Research Education Programs)

Payment and Fees

Application fees consist of the exam fee and the application fee. Applications submitted after the regular deadline,
during the extended deadline period, incur an additional Late Fee of $150.
Exam fees vary depending on membership with ACRP or its affiliate, the Academy of Physicians in Clinical
Research (APCR). To understand the various rates, use the cost calculator on the ACRP website at:
www.acrpnet.org/popups/crc-fee-calculator.html. To learn more about membership, visit:

12

www.acrpnet.org/membership. To activate the ACRP member rate, the applicant must join or rejoin ACRP
before applying for the exam. Membership fees are non-refundable.
All exam fees include a nonrefundable $115 application fee regardless of eligibility status or cancellation.
The late fee is also nonrefundable.

CCRC Application and Exam Fees

Standard Fee
Regular Deadline

ACRP Member Fee

Regular Deadline

Standard Fee
Extended Deadline

ACRP Member Fee

Extended Deadline

$115

$115

$115

$115

$547

$347

$547

$347

Late Fee
Nonrefundable

--

---

$150

$150

TOTAL
AMOUNT DUE
at Application

$662

$462

$812

$612

Application Fee
Nonrefundable
Exam Fee

Submitting the Application

Only applications received with required supporting documentation and full payment will be processed.

CCRC Methods of Payment and Delivery

Payment Method

Application
Method
Online via
ACRP website
(recommended)

1. CV/resume
2. Job description
3. Educational program certificate (if required)
Upload documents as part of application

Printable form from

ACRP website
Mailed or Faxed
accepted

1. CV/resume
2. Job description
3. Educational program certificate (if required)
Mail or Fax documents together

Printable form from

ACRP website
Mailed as hard
copy

1. CV/resume
2. Job description
3. Educational program certificate (if required)
Mail documents with application

Credit Card

Check or
Bank/Wire Transfer

Documents Required to be Submitted WITH Application

VERY IMPORTANT: Incomplete applications, or applications submitted without the correct fee, will not be
processed. It is the candidates responsibility to submit all relevant documents at the time of application. All fees
must be paid in full by check or credit card (American Express, VISA, or MasterCard). Corporate checks must
reference each applicants name.

13

Submission of the application constitutes agreement that the candidate has read, understood, and agrees to
abide by the ACRP/APCR Code of Ethics and Professional Conduct. Applicants are required to sign a disclosure
statement attesting to the accuracy of the information provided as part of the application process. By submitting
an application, the applicant consents to and authorizes the Academy to verify the candidates academic and
employment records. Application for, and achievement of, Academy Certification is between the Academy and an
individual candidate. Therefore, application details and status, fees, eligibility status, exam appointments, and
exam results are confidential to the individual and cannot be disclosed, regardless of payer. Only the candidate is
permitted to withdraw an application or cancel an exam appointment, regardless of payer.

Receipt of Application
An e-mail confirmation of payment is automatically sent once payment is processed. A second e-mail confirms
that the application was received by the Academy and is being prepared for the Eligibility Review process.
NOTE: These confirmations do not confer eligibility. A separate notification will be sent regarding an eligibility
decision. Please take any necessary steps to prevent filtering of ACRP e-mails.
If the printable application is submitted, it is highly recommended that the applicant mail it to the Academy via
certified mail, express parcel service, or another traceable courier to ensure receipt by the application receipt
deadline. Keep fax confirmations for tracking purposes, if sending the application via fax.

Withdrawal of Application
Once a candidate submits an application, it cannot be withdrawn. Candidates who wish to discontinue the
Certification process may submit a request via e-mail to [email protected] to obtain a refund of the
Exam Fee only. The application fee is nonrefundable. Only the candidate may request to cancel the
Certification process. If a candidate submits such a request after the candidate has received an Eligibility ID, the
ID number will be invalidated.

Meet Eligibility
Requirements

Apply

Eligibility
Schedule
Review
Exam
Eligibility Review

Prepare

Take
Exam

The Eligibility Review process includes determining completeness of the application and determining whether or
not the applicant meets the eligibility criteria for the exam. This process begins within one week of receiving the
application and may take up to two weeks to review before any update is emailed.
It is not unusual for an applicant to receive a request for additional and/or clarifying information from an Eligibility
Reviewer. These requests will come via e-mail. Applicants will have seven (7) calendar days to respond to the
request. Applicants who do not respond to the request for additional or clarifying information will automatically
have their applications determined incomplete and therefore are ineligible to take the exam. Ineligible applicants
will be refunded the exam fee ONLY, and will need to re-apply to the program and pay all fees if they decide to
pursue Certification in the future. Incomplete applications will not be returned.

Confirmation of Eligibility and Testing Information

If an applicant is determined to be eligible after the application has been reviewed, the candidate will be emailed an Eligibility Notice, with further instructions as to how to schedule his/her exam appointment.
If an applicant is determined to be ineligible during initial review, the application is automatically reviewed by a
second reviewer. If the second reviewer also determines the applicant to be ineligible, the application is

14

automatically sent to the Director of Certification for a third review. Applicants are notified via e-mail at each step
of the review with an explanation of the deficiency identified.
If, after the three levels of review, the applicant is still determined to be ineligible, the applicant can choose to
appeal to the Academy Board of Trustees. However, after the third level of review by the Director of Certification,
applicants can no longer submit NEW documents to overturn an eligibility decision.
Applicants found to be ineligible who do not initiate the Appeals process within the stipulated timeframe will
automatically be refunded the exam fee ONLY, within a month.

Ineligibility Decision Appeals Process

The Academy of Clinical Research Professionals (the Academy) makes every attempt to make fair and accurate
eligibility decisions based on the information provided by the applicants. An appeal procedure is available to any
applicant who has applied for certification by the Academy and who wishes to contest any adverse decision
affecting his or her application for certification status. Any individual who does not file a request for an appeal
within the required time limit shall waive the right to appeal.
Candidates are permitted to appeal a decision made during the review of his/her application for certification.
Candidates are not permitted to appeal:
1. The passing score for the exam, or the process used to establish that passing score, which may result in failure
of the certification examination.
2. Existence of an eligibility requirement. The Policy on the Appeal of Denial of Eligibility provides for appeal of the
interpretation of the eligibility requirements in individual applicants circumstances.
Candidates do have the ability to appeal the content and quality of the examination, as well as questions and
answers. However, candidates may not have access to the test form, their answers, or the answer key. Read the
Academys Policy on Appeal of Denial of Eligibility section, for details.

Meet Eligibility
Requirements

Apply

Eligibility
Review

Schedule
Exam

Prepare

Take
Exam

Exam Scheduling
Exam Dates
February 28 March 16, 2013
The Academy offers a 17-day testing window. All candidates who have been determined eligible must schedule
an appointment to take the exam.
Exams are scheduled through Prometric, the Academys testing partner, and may be taken at approximately 600
testing centers internationally. Only candidates determined to be eligible will receive an Eligibility Notice
immediately following the Eligibility Review process. This important notice includes a Prometric ID number, the

15

Prometric Exam Scheduling web address, and instructions for scheduling a personal exam appointment.
Candidates select the testing center, exam date, and time on a first-come, first-served basis.
To view testing locations, visit www.prometric.com/acrp at any time. For detailed assistance with selecting your
test center, view www.acrpnet.org/PDF/ExamSites.pdf.

Services for People with Disabilities

The Academy is committed to ensuring that no individual with a disability is deprived of the opportunity to take an
exam solely by reason of that disability. The Academy will provide reasonable accommodations for candidates
with disabilities pursuant to the Americans with Disabilities Act (ADA). The following reasonable accommodations
may be addressed:

Wheelchair access is available at all established test centers.

Candidates with visual, sensory, cognitive, or physical disabilities that would prevent them from taking an
exam under standard conditions may request reasonable accommodations and arrangements.

To request a reasonable accommodation, one is required to:

Submit to the Academy a Special Accommodations Form, signed by a licensed health professional
approving the request as accurate and reasonable.
Check the designated box on the exam application.

The Special Accommodations Form is available in Appendix 2. A link to the Special Accommodations Form is
also available in both the online and printable applications. Complete and submit this form with your application to
[email protected]. Only reasonable accommodation will be made during the available exam window.

Rescheduling Exam Within Same Exam Cycle

Rescheduling your exam appointment (test center location, date, or time) is permitted by Prometric up to five (5)
days before your scheduled appointment. Contact Prometric directly at 800-853-6769 or online at
www.prometric.com/ACRP. There may be fees associated with appointment changes, as detailed below.

Rescheduling Exam Appointments

Time Before Appointment
More than 30 days before
scheduled appointment

29 to 16 days before scheduled

appointment

15 to 5 days before scheduled

appointment

Prometric Fees

Method
Online or via phone

No charge

$25

Online or via phone

Online or via phone

$50

16

Less than 5 days before

scheduled appointment

Not permitted full exam fee

forfeited

Rescheduling due to emergency

See policy below

Failure to appear for scheduled

exam

All fees forfeited

Emergency Exam Cancellation

Form sent to the Academy

Transfer to Next Exam Window

The Academy offers a one-time* transfer from the current exam offering to the next. There are two situations in
which candidates may take advantage of this:
1. If a candidate is determined INELIGIBLE for the current exam window, but will have met the eligibility
requirements by the next exam window; or
2. If an ELIGIBLE candidate withdraws from taking the original exam for any reason (up to five [5] days
before a scheduled exam appointment)
Transfers are applied toward the next exam ONLY.
If a candidate wishes to transfer to the next exam window for one of the two reasons above, the candidate must
complete an Exam Transfer Request Form before the end of the exam window for which the candidate originally
applied.
If a transfer candidate does not submit the Exam Transfer Request Form before the end of the current exam
testing window, then all funds originally submitted will be forfeited.
Transfer of eligibility and associated fees will be applied only to the original candidate and are not transferable to
another person, even if paid for by a third party. Exam fees associated with transferring may be used only toward
the next exam and not toward other products or services.
If the candidate originally paid the member price, but his or her membership has expired when reactivating the
credit for the next exam, the candidate must pay the difference between the standard and membership price.
If the exam fee increases from one cycle to the next, the original exam fee submitted will be honored unless
membership fees or the difference between the standard and membership rates is due.

Reactivation Form (for Transferred Exams)

Once a candidate has indicated his/her interest in transferring to the next testing window, he or she must submit a
Reactivation Form to signal his/her intent to test. The Reactivation Form is e-mailed directly to the candidate at
the start of the next exam application period. The form must be submitted by the regular deadline for the next
testing window. If a candidate who has transferred his/her eligibility does not submit a Reactivation Form by the
regular deadline, the candidate will forfeit all fees.

Cancellations
Cancelling your exam appointment (test center location, date, or time) is permitted by Prometric up to five (5)
days before your scheduled appointment by contacting Prometric directly at 800-853-6769 or online at
www.prometric.com/ACRP. There may be fees associated with appointment cancellations, as detailed below.

17

Cancelling Exam Appointments

Time Before Appointment

Prometric Fees

More than 30 days before

scheduled appointment

No charge

29 to 16 days before scheduled

appointment

$25

15 to 5 days before scheduled

appointment

$50

Less than 5 days before

scheduled appointment

Method
Online or via phone

Online or via phone

Online or via phone

Not permitted full exam fee

forfeited

Cancellations due to emergency

See policy below

Failure to appear for scheduled

exam

All fees forfeited

Emergency Exam Cancellation

Form sent to the Academy

Note: See the Refunds section below. The Academy does not refund fees for exam cancellation requests
received fewer than five (5) days prior to the scheduled exam.
To cancel an exam appointment it is mandatory that the candidate FIRST contact Prometric directly at 800-8536769 and SECOND contact the Academy at [email protected]. Only the candidate may request a
cancellation, regardless of whether the exam fee was paid by the candidate or another party.
Refer to the Transfer to Next Exam Window section for an alternative to cancellation.

Emergencies
If a candidate will be unable to keep his/her exam appointment due to an emergency situation that arises within
five (5) days prior to his/her exam date, the candidate is required to submit an Emergency Cancellation Form
and official documentation to the Academy at [email protected]. This information must be received by
or up to seven (7) calendar days after the candidates scheduled exam date. The following situations will be
considered with documentation:

Emergency room visit or hospitalization

Severe medical condition requiring hospitalization
Death of an immediate family member (e.g., spouse, child/dependent, parent, grandparent, sibling)
Jury duty
Call to active military duty

Refunds
If a candidate must cancel an exam, the only portion of the total amount submitted that will be refunded is the
exam fee, provided that the request for cancellation is received at least five (5) calendar days prior to a scheduled
exam appointment. Application and late fees are nonrefundable. Cancellation requests received after that time will
not be honored. Refunds are not available to candidates who do not attend the exam. Refund requests will be
accepted only if made by the candidate.

18

Applicants who do not meet the eligibility requirements for the exam (i.e., those who are ineligible), or who are
ineligible due to an incomplete application, will receive a refund of the exam fee only, within three weeks of the
final ineligibility notification.
Refund requests can be made by the candidate only. Employers supporting a candidates fees cannot request or
receive a refund for fees paid to the Academy. Any refund will be sent to the party who initially paid for the exam.
If payment was made by credit card, that card will receive the credit. If the payment was made by check, the
Academy will mail a refund check to the original payer.

Meet Eligibility
Requirements

Eligibility
Review

Apply

Schedule
Exam

Prepare

Take
Exam

Prepare to Take the Exam

Preparation to take the Certified Clinical Research Coordinator (CCRC ) Examination can begin as early as one
decides to pursue Certification. Understanding the exam content, as well as how to apply ones knowledge and
experience while taking the exam, is essential to successfully becoming certified.

Written Exam

The CCRC Examination is designed as a practice-based exam for individuals involved in the performance of the
essential duties of a clinical research coordinator to assess proficiency of the five (5) core knowledge areas:
1. Investigational Product Management
2. Protocol
3. Safety
4. Trial Management
5. Trial Oversight
The examination consists of 125 multiple-choice questions (25 of these questions are pre-test items and do not
affect a candidates score). Candidates are presented with a question and are asked to choose the single BEST
answer from the four options provided. Only one answer is correct. The questions test recall, application, and
analysis. Some questions use hypothetical scenarios. The exam content is based on a process of expert peer

review, performed by the Global CCRC Exam Committee. There are no trick questions on the exam, and there
is no penalty for guessing.
Each candidate is allowed a maximum of three (3) hours to complete the exam.

Language

The CCRC Exam is provided in English.

Exam candidates may bring a hard-copy English-German/Spanish/Chinese/Hindi/etc. translation dictionary to the
exam. Electronic dictionaries are not permitted. The dictionary will be inspected by the proctor prior to and after
the exam is completed. Any attempt to compromise the exam will be grounds for immediate dismissal from the
site, invalidation of the exam score, and possible legal action. No additional time is given to those using a
translation dictionary.

What is Covered on the Exam?

19

To be certified, clinical research coordinators are expected to have general knowledge of:

laboratory terminology, tests, and procedures

basic math, including adding, subtracting, multiplying, dividing, and calculating percentages

To be certified, clinical research coordinators are expected to have proficiency in the areas of:

The Detailed Content Outline (DCO) for the Clinical Research Coordinator Exam.

Detailed Content Outline (DCO)

The DCO is derived from the 2010 ACRP Job Analysis Survey, a careful description of the tasks performed by
clinical research coordinators. Nearly 4,000 clinical research professionals participated in the 2010 survey. This
survey is conducted every five (5) years. The DCO is updated accordingly and the exam questions revised to
reflect any changes in practice. Each question on the exam is based on this outline. Therefore, to prepare to take
the exam, one should study this outline and especially consider the underlying knowledge, skills, and abilities
needed to perform as a clinical research coordinator:
Certified Clinical Research Coordinators (CCRCs) shall have proficiency in:

I.

Investigational Product Management

Ensure adequacy of investigational product and other supplies at site

Ensure randomization and emergency codes of investigational product have been maintained
Ensure proper storage, dispensing, handling, and disposition of investigational product and other
supplies
Reconcile investigational product and other supplies
Maintain accountability of investigational product
Prepare investigational product according to the protocol
Dispense investigational product according to the protocol
Retrieve investigational product and calculate subject compliance
Maintain randomization and emergency codes of investigational product dispensing
Prepare emergency use report

Using knowledge of:

Investigational product (e.g., package insert, report of prior investigations, Investigator's
Brochure)
Investigational product inventory
Investigational product accountability
Investigational product storage
Packaging and labeling
Supplemental/rescue/comparator product
Investigational product compliance (e.g., protocol, standard operation procedures, local
governance)
Accountability records

II.

Protocol

Evaluate protocol for feasibility

Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data
capture (EDC)) with the study protocol
Verify the eligibility of potential trial subjects
Contribute to protocol development
Coordinate protocol approval process
Review protocol for feasibility

20

Review protocol during Investigators meeting

Execute study per protocol
Recommend and implement protocol amendments

Using knowledge of:

Protocol development
Protocol submission and approval procedures
Clinical trial phase
Study design characteristics (e.g., double-blind, crossover, randomized)
Study objective
Description of procedures
Amendment submission and approval procedures
Inclusion/exclusion criteria
Statistical plan

III.

Safety

Assess safety during trial participation

Minimize potential risks to subject safety
Oversee safety risks (e.g., clinical holds, product recalls)
Report required adverse events to regulatory authorities and/or IRB/IEC
Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected,
unexpected)
Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts)
Handle medical monitor oversight
Conduct study-related procedures and monitor the safety of the trial subjects and investigational
staff
Manage and motivate the investigational staff and other disciplines involved, and take measures
to minimize any potential risks
Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit
progress reports to the IRB/IEC per requirements
Review common laboratory values and alerts
Determine and document the causality of adverse events
Identify expected or unexpected results associated with investigational products
Implement Investigators plan of action for management of adverse event (e.g., stop
investigational product; call, retest, treat subject)
Maintain follow-up to determine resolution of adverse event
Report serious adverse event to Sponsor/CRO and IRB/IEC
Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
Record adverse event and relevant information on source document
Document reasons for subject discontinuation (i.e., causes, contact efforts)
Document follow-up medical care for study subjects, as applicable
Conduct safety monitoring/reporting activities
Initiate un-blinding procedures

Using knowledge of:

Investigators Brochure
Safety monitoring
Safety and clinical databases
Subject safety issues (e.g., toxicity, significant lab values)
Adverse events reporting
Serious adverse events reporting
Safety reporting requirements

21

IV.

Trial Management

Verify investigator/site feasibility

Develop timelines for conducting and completing the clinical trial
Prepare and conduct initiation activities
Ensure appropriate training of the investigational staff
Develop a recruitment strategy and study management plan
Follow a recruitment strategy and study management plan
Schedule and coordinate pre-study site visit
Identify minimum regulatory document requirements for site trial master file (e.g., country-specific
regulatory documents)
Ensure IRB/IEC review/approval of study and study documents
Facilitate site budget/contract approval process
Submit documents to regulatory authorities
Document and communicate site visit findings
Ensure clinical trial registry requirements are met
Ensure timely review of study data (e.g., laboratory results, x-rays)
Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
Prepare and conduct close-out monitoring visit(s)
Prepare study summary and/or close-out letter for IRB/IEC
Document protocol deviations/violations
Evaluate study for feasibility
Schedule subjects
Obtain informed consent and screen trial subjects
Prepare study documents for IRB/IEC and/or sponsor review/approval
Prepare study documentation (e.g., schedule of events, description of procedures)
Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g.,
protocol procedures, EDC)
Select the investigational staff and assign roles and responsibilities
Develop a recruitment strategy and site study management plan
Transmit CRFs to Data Management
Review CRF queries from Data Management
Coordinate study monitoring visits
Select and manage local vendors (e.g., laboratory, x-ray, MRI)
Draft study specific tools (e.g., source document, tracking tools)
Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
Conduct subject visits according to requirements
Implement corrective actions plans
Maintain trial master file (e.g., regulatory binder)
Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
Maintain standards for handling hazardous goods (e.g., IATA)
Manage study supplies (e.g., lab kits, case report forms)
Maintain equipment (e.g., calibration and preventive maintenance)
Manage study record retention and availability
Manage financial agreements
Comply with subject privacy regulations
Prescreen telephone calls for eligibility requirements
Maintain subject screening/enrollment log
Collect, record, and report accurate and verifiable data
Manage study issues

Using knowledge of:

22

Site Activities
Contract budget negotiations and approval process
Monitoring guidelines/plan and tools
Disposition of unused study-related materials (e.g., CRF at end of study, destruction of lab
kits)
Equipment and supplies (e.g., x-ray, computer, lab kits) and storage
Pre-study site visit
Investigator's meeting
Site initiation
Monitoring visit
Close-out visit
Site monitoring visit log
Site signature log
Delegation listing
Trial master file (e.g., site, sponsor)
Regulatory documents
Record retention
Visit reports (e.g., initiation, close-out)
Final report
Progress reports
Protocol Compliance
Project feasibility
Study project tools
Sample collection, shipment, and storage
Study management plan (e.g., timelines, data management)
Good Clinical Practice
Procedure manuals
Protocol deviations

Subject Scheduling, Screening, Recruitment, and Retention

Project timelines
Recruitment plan/strategies
Subject compliance
Subject visit logistics
Subject selection, screening, and recruitment
Subject retention
Subject discontinuation
Clinical trial registry
PI Oversight/Qualifications
Staff qualifications
Staff roles and responsibilities
Plan for staff oversight
Investigator qualifications/site selection (e.g., therapeutic area, education, experience)
Plan for ancillary staff education
CRF/Source Documents
Data management activities
Communication documentation (e.g., telephone, email)
Data management plan

23

Data query resolution

Electronic data (e.g., electronic health records, electronic case report forms)
Case Report Form
Essential documentation, subject related and non-subject related (e.g., past medical records,
lab reports, protocol, IRB approvals)
Source documentation

Consent/Assent
Vulnerable subject populations
Communication with subjects
Protection of human subjects
Subject reimbursement
Subject privacy regulations
Informed consent
Indemnification/insurance

V.

Trial Oversight

Ensure consistency between the sites standard operation procedures (SOPs) and the study
requirements
Ensure investigator/site protocol compliance
Facilitate investigator/site corrective actions
Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
Ensure adequate site management
Prepare the study site for audits and inspections
Respond to or facilitate response to audit/inspection findings
Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of
slides, freezing, refrigeration)
Ensure proper adverse event reporting by the investigator
Escalate problems to appropriate in-house management
Investigate potential fraud and misconduct
Report potential fraud and misconduct
Ensure follow-up medical care for study subjects is documented, as applicable
Ensure adequate consent and documentation
Ensure staff, facility, and equipment availability throughout the study
Ensure compliance with study requirements and regulations
Prepare for audits, inspections, and follow up
Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect
confidentiality by limiting unauthorized access
Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are
on file

Using knowledge of:

Issues management (e.g., escalation)
Audit preparation
Regulatory standards
Audit documents
Project monitoring guidelines
Project investigator supervision requirements

Study Texts
In order to prepare for the exam, all candidates should review and be familiar with the relevant regulations from:

ICH Guidelines (E2A, E6, E8, E9)

24

Declaration of Helsinki (latest version)

The most current copy of the ICH Guidelines and other regulatory materials may be found on the following
websites:

ICH Guidelines: www.ich.org

Declaration of Helsinki: www.wma.net/en/20activities/10ethics/10helsinki/index.html

Abbreviations List
Access to the Abbreviations List here is accessible on each screen during the exam. You can expect to see the
following terms abbreviated as shown.

Certification Exam Abbreviation List

ADR

Adverse Drug Reaction

AE

Adverse Event

ALT

Alanine transaminase

AST

Aspartate transaminase

b.i.d.

twice a day

BP
BUN
C
CIOMS
CK

blood pressure
Blood Urea Nitrogen
Celsius
Council for International Organizations of Medical Sciences
Creatine Kinase

CRA

Clinical Research Associate

CRC

Clinical Research Coordinator

CRF

Case Report Form

CRO

Contract Research Organization

CV
DCF
DSMB

Curriculum Vitae
Data Clarification Form
Data Safety Monitoring Board

ECG

Electrocardiogram

eCRF

Electronic Case Report Form

EDC

Electronic Data Capture

EKG

Electrocardiogram

FEV1

Forced Expiratory Volume in 1 Second

GCP

Good Clinical Practices

GI
GLP

Gastrointestinal
Good Laboratory Practices

25

GMP

Good Manufacturing Practices

hCG

Human Chorionic Gonadotrophin

HMO

Health Maintenance Organization

IB

Investigator's Brochure

ICF

Informed Consent Form

ICH

International Conference on Harmonization

IP
IRB/IEC

Investigational Product
Institutional Review Board/Independent Ethics Committee

LAR

Legally Acceptable Representative

MAO

Monoamine Oxidase

mcg

mircogram

mmHg

Millimeteres of mercury

NSAID

Non-Steroidal Anti-Inflammatory Drug

PI

Principal Investigator

PK

Pharmacokinetics

p.r.n.

as needed

QA

Quality Assurance

QC

Quality Control

q.d.

once a day

QTc

ECG / EKG QT interval corrected for heart rate

RBCs

Red Blood Cells

SAE

Serious Adverse Event

SMO

Site Management Organization

SOP

Standard Operating Procedure

SUSAR
t.i.d.
wBCs

Suspected Unexpected Serious Adverse Reaction

three times a day
White Blood Cells, or leukocytes

ACRP Online Preparation Support

Optional preparation support, developed by ACRPs Professional Development program, is available for purchase
on the ACRP website on the Certification Exam Preparation web page. The Academy offers an Internet-based
Exam Practice Exercise, consisting of 50 multiple-choice questions and reference to the applicable ICH
Guidelines to help you prepare for the ACRP Certification Exams. Each Exam Practice Exercise is tailored to help
you sit for the exam, in the job function you actually perform (i.e., CRA, CRC, or PI).
Additionally, ACRP offers an Exam Preparation Guide, which may be purchased separately from the Practice
Exercise or as a bundle. For complete details and purchasing, visit the Certification Exam Preparation web page.
ACRP members are invited to join the Certification Exam GPS group in ACRPs Online Community, where
exam candidates can gain valuable peer support, pose questions, make comments, and find periodic examrelated information from the Academy. To join the Certification Exam GPS group, log in to www.acrpnet.org

26

with your e-mail address and password and click Community/Visit Community. You must be a current ACRP
Member to participate.

Preparing for the CCRC Exam

The CCRC Examination is intended to assess your proficiency of the body of knowledge required to perform in
your job role as a clinical research coordinator. The knowledge and tasks that are being tested are based on
current practice in clinical research. It is testing your knowledge of ICH and GCP and the application of those
guidelines in the conduct of your job duties and responsibilities. It is not testing how your employer or you
personally carry out those duties.

The CCRC Examination is specific to the role that CRCs play in the conduct of a clinical trial. The exam content
expects that you will have a basic working knowledge of general laboratory terms, tests, and procedures, as well
as how to perform basic math. It requires a general working knowledge of the roles and responsibilities of CRCs,
even if your employer does not require you to function in that role.
No two candidates come to the exam with the same knowledge base. Since experience and educational
backgrounds are unique, these differences must be taken into consideration when determining a study method.
Although some individuals may take the exam without any preparation, the majority become involved in some
form of exam preparation. Because the exams measure proficiency of the application of the knowledge required
to be an effective CRC, it is impossible to train or teach to the exam. The best preparation is to understand the
CRC knowledge requirements (see the Detailed Content Outline, which was provided above) and their application
to clinical research.
A clinical research coordinator who has met the eligibility requirements to sit for the examination should have the
knowledge needed to take and pass the examination. You might want to review the Detailed Content Outline for
topics or subtopics with which you are less familiar. If you find a particular area with which you are not familiar or
comfortable, that would be an area on which to focus your study or review. Or, you may want to do a surface
review of all the content areas, even those you believe you know well.
Because of the nature of the exam, there is not one comprehensive source to go to in order to study. However,
the Academy does recommend that you review the content areas covered on the exam by using the Detailed
Content Outline, which was provided above.

Steps to Preparing for the CCRC Exam

STEP 1: Assess your own professional experience. Read carefully through the Detailed Content
Outline description provided in this handbook. Compare the detailed description of knowledge and tasks,
plus the proportion of questions, to your own professional experience. Rate your relative skill level and
experience on a scale of 05 (0 = no experience) as an indicator of how prepared you are and where to
invest more of your study focus in preparing for the exam.
STEP 2: Start early and plan ahead. You must complete and submit your detailed application at least 45
days before the exam. Dont leave this until the last minute! Focus some learning time on reading in every
content category, but spend extra time reading in those categories where your experience is limited.
Match your study efforts in relation to the time you have available and the specific study needs you have
identified for yourself. Every exam candidate will answer the same number of questions in every category.
STEP 3: Schedule your study time. If you decide to set up a study group, you should hold weekly
meetings that will take about two hours on one day/evening every week. Schedule flexible blocks of time
into your day timer. The key is not to memorize what you read, but to understand concepts behind
ICH/GCP and best practices in each knowledge category area to supplement your experience in
answering questions on the exam. Read at night, on the subway, over lunch, and read, read, read!

27

STEP 4: Assemble your study notes in a binder. It may help you to organize your study notes, articles,
book summaries, etc. in a binder using either the eight topics of the study manual modules, the six exam
categories, or your own index. Let your experience guide you in your strongest areas, and focus more
time in your weaker areas in relation to the relative value that each area will be to you on the exam. Or,
you can create flashcards to use as study aids.
STEP 5: Choose the methods that are right for YOUR study plan. Choose a mentor or colleague who
has more experience in the areas in which you are less familiar and ask him/her to review concepts with
you. As you perform your daily responsibilities, think about the underlying principles that lead you to take a
particular course of action.
STEP 6: Stick to your study groups plan. Pick a regular night and show up on time. Each of you has the
same goal, and everyone has something to offer. Sharing reading and exchanging book notes is a great
way to lighten the load. Study groups foster friendships and provide an incentive to stay focused on your
collective goal. Complete; dont compete.
STEP 7: Dont panic! Follow the excellent pre-exam advice that the Academy provides, and come to the exam
well-rested and prepared. Approximately 74% of candidates are successful on their first exam attempt.

Further Study Tips

In addition to reviewing the ICH Guidelines, one way to review is to select texts and training materials you used
when first taking on the role of a CRC. You can select a publication that you may already have on your bookshelf,
or one that you can borrow from a colleague. You should select books or publications that cover topics found on
the Detailed Content Outline, the ICH Guidelines, or the tenets of GCP.
If you have time, take a workshop or attend a conference session on topics in which you need to become more
familiar. Any professional development courses that cover clinical research topics will add to your knowledge
base and therefore will help you prepare for the exam.
NOTE: The Academy does not sponsor or endorse any specific educational courseseven if the course
is advertised as a prep or review course for the CCRC Exam. Courses titled this way are at the
discretion of the organization offering the course. Those creating the course have NOT had any inside information
about the exam. The same information that is included in this handbook to help you prepare is publicly available
to those creating educational content. Participation in these courses may help you learn or review topics covered
on the exam, but you should not expect them to directly cover exam content.

Test-Taking Strategies
Most adults havent taken a standardized exam recently. It can be helpful to be reminded of some key strategies
for how to approach a multiple-choice exam:

Read the entire question before you look at the possible answers.
Come up with the answer in your head before looking at the possible answers; this way, the choices
given on the test won't distract you from focusing on the question.
Eliminate answers you know are not correct.
Read all the choices before choosing your answer.
There is no guessing penalty, so its always best to take an educated guess and select an answer.
Don't keep on changing your answer; usually your first choice is the right one, unless you misread the
question.
Go through the exam and answer the questions you know first. Mark the others for review and then go
back to those you skipped over. This will ensure that you dont lose time by focusing on one question you
arent sure about.

28

Meet
Eligibility
Requirements

Apply

Eligibility
Review

Schedule
Exam

Prepare

Take
Exam

Taking the Exam

Identification
Exam candidates are required to present two (2) forms of valid and non-expired identification (ID) at the test
center, as follows:
1. The primary form must be a current government-issued photo- and signature-bearing ID for the
candidate. This includes a drivers license, passport, or other state- or government-issued ID.
2. The second form of ID must include the candidates signature. This may include a credit card, ATM card,
military ID, citizenship card, or social security card.
It is imperative that the candidate ensure the first name and last name (middle names excluded) on BOTH IDs are
identical and match the first and last name as they appear on the Appointment Confirmation. A marriage
license may only be used to verify a name change and is not considered to be a valid form of identification.
Contact the Academy office immediately, before the test appointment, at [email protected], if this
information is incorrect or changes.
Candidates will not be admitted to the exam without proper identification. If a candidate arrives at the test center
without proper ID, the appointment will be forfeited and the candidate will be required to reapply and repay fees to
take the exam.
Name changes are common, but can prevent a candidate access to the exam if not properly presented. If a
candidate is identified by a different name for the exam than that which is listed on the IDs, the candidate will be
permitted only if those IDs are accompanied by a government-issued certificate supporting the name change
(e.g., a marriage certificate with previous and current name).

Time
It is the candidates responsibility to arrive on time for the exam appointment. If the candidate is late by 15
minutes or more, the test center has the authority to turn the candidate away and not permit the candidate to take
the test. Candidates denied access due to lateness must first contact ACRP and pay the $65 rescheduling fee
before being permitted to reschedule the appointment. An appointment time will be rescheduled ONLY if one is
available at the test site within the current exam period. No refunds will be given if the exam cannot be
rescheduled.

29

Including check-in time, pre-exam procedures (computer tutorial), exam, and post-exam evaluation, be prepared
to stay at the exam site three-and-a-half to four hours.

Test Center Guidelines

Length of the exam: All Certification exams have a time limit of three hours from the time the exam is

started.
Supplies needed: An online calculator will be available at the test center and a whiteboard will be
provided for comments. Candidates can request a hand-held calculator, which will be provided by the test
center. Study aids are not permitted. Non-electronic strict translation dictionaries are the only dictionaries
permitted, but will be examined both before and at the end of the exam. Use of translation dictionaries is

discouraged, as this eats into valuable test time.

Personal items: Lockers are available for personal items that are not permitted in the exam room. Some
examples include cell phones, facial tissues, watches, and keys. It is recommended that you not bring

unnecessary personal items to the center.

Visitors: No visitors will be allowed in the test center.

Room temperature: It is advised to dress in layers to prevent being too hot or too cold during the exam.

Computer issues: If any issues arise, notify the proctor immediately (e.g., calculator malfunction, exam
stops prematurely, etc.) by raising your hand. The attendant is constantly monitoring the room either by

video monitor or in person.

Noise: Candidates will be testing in a room with other candidates who may be taking other types of
professional exams. The test center will have available noise-cancelling headphones, which a candidate
can request if desired. You cannot bring your own.

Exam Security
Exam content will be transmitted via encrypted electronic file to each exam site to ensure the security of the exam
questions. Computer-based testing allows for different versions of the exam to be offered and for changes in the
sequence of questions; this reduces the likelihood of misconduct and enhances the validity and integrity of the
exam. Each exam will be delivered via individual video-monitored testing carrelsboth to provide better privacy
while the candidate is taking the exam and to prevent unethical behavior.
Examinees will be presented with Prometric Testing Center Regulations upon arrival at the test site. It is
imperative to read the information provided. Those who violate security will not have their exams scored or
processed, and will be required to leave the room immediately. To view regulations in advance, visit
www.prometric.com/Testing-Center-Regulations.
Removing or attempting to remove exam material or content from the testing center will result in severe criminal
and civil legal consequences.

Exam Results
Computer-based testing provides participants with preliminary results immediately. On-site notices are preliminary
and candidates are not yet considered certified until official notification is received from the Academy.
Official confirmation of results will be mailed 30 days following the close of the testing window. Candidates who

30

pass the exam will be sent an official notice of Certification, a certificate, a CCRC pin, and Maintenance of
Certification information.
Candidates who do not pass the exam are advised to review the content area proficiency ratings and use this
information to assist in preparing for future exams.
Final exam results will NOT be given out over the telephone or by fax, nor will results be sent to employers,
schools, other individuals, or organizations under any circumstances. Candidates who pass the exam will be
added to the Academy Certification registry unless this option was de-selected at the time of application. The
registry can be accessed at www.avectraacrp.com/Certlist.

Exam Scores
Prometric, the Academys professional testing partner, scores all exams. One point is granted for each correct
answer. There is no penalty assessed for an incorrect answer; points are scored only for correct answers. The
number of questions answered correctly (or total points) is a candidates raw score.
A candidates raw score is converted to a scaled score. The "Total Scaled Score" will determine whether a
candidate has passed the exam. This scaled score is statistically derived from the candidate's raw score and can

range from 200 to 800. The passing scaled score for the CCRC exam is 600. The passing score reflects the
minimum amount of knowledge a committee of experts has determined to be appropriate for Certification,
according to accepted test development guidelines.
A criterion-referenced, standard-setting procedure and expert judgment are used to identify the passing point. The
Academy uses the widely accepted Modified Angoff method. A candidate's ability to pass the exam depends on
the amount of knowledge he or she demonstrates, not on the performance of other individuals taking the exam.
The reason for calculating scaled scores is that different forms or versions of the exam may vary in difficulty. As
new versions of the exams are introduced, a certain number of questions in each content area are replaced by
new questions. These changes may cause one version of the exam to be slightly more or less difficult than
another version.
To adjust for these differences in difficulty, a statistical procedure called "equating" is used. The goal of equating
is to ensure fairness to all candidates. In the equating process, the minimum raw score (number of correctly
answered questions) required to equal the passing scaled score is statistically adjusted (or equated). For
instance, if the exam is determined to be more difficult than the base form of the exam, then the minimum raw
score required to pass will be slightly lower than the passing scaled score. If the exam is a bit easier, then the
passing raw score will be slightly higher than the passing scaled score. Equating helps ensure that the passing
scaled score represents the same level of knowledge, regardless of which version of the exam a candidate takes.
A candidate scoring below the minimum scaled score has not been successful on the exam and cannot be
certified. The exam is not scored on a curve. There is no predetermined number of candidates permitted to pass.
Your score does not depend on the other candidates testing with you that day.
Note: The passing point set for the exam cannot be appealed. To score one point below the passing point is to be
unsuccessful on the exam; to score at the passing point or higher is to pass the exam. A score higher than the
passing point is not an indication of a higher proficiency in the subject matter.
Specific questions on the exam and/or answers to exam questions will not be discussed or released. Due
to the security of the item bank and because exam questions can be used on various exams, exam questions will
not be discussed with candidates and candidates may not have access to the exam or their answers.

31

Scaled Scores and Score-Reporting FAQs

Commonly asked questions and information about scaled scores and score reports is provided below.
1. Why are scaled scores used?
They are used to provide a consistent scale of measurement, so that from one test administration to the next, the
same scaled score represents the same level of knowledge. Each exam administration has multiple exam forms
in use, and some forms may be more difficult than others. A scaled score keeps the level of knowledge required
to pass constant.
2. Why not just use the number of items answered correctly?
This may provide useful information about your performance on different parts of the test, but does not take into
account the difficulty of the items.

3. Is a scaled score the same as a percentage score?

No. Calculation of a percent correct is a way to convert a raw score to another scale, but a scaled score is not
the same as a percent correct. You could calculate percentage scores by dividing the number correct by the total,
for example, a raw score of 9 in a category with 15 total items relates to 60% correct, but a scaled score of 600
does not relate to 60% correct.
4. How should I interpret my performance on the category scores?
When reviewing your proficiency for the major categories, bear in mind that all categories are not equally difficult.
Those areas indicating below proficient are areas where additional study or review would be helpful.
5. Why dont I get a percentage score on my report?
Similar to a raw score, converting your score to a percentage score would not take the difficulty of the items into
account.
6. How is the scaled score computed?
To calculate a scaled score, the raw score required to pass is first set equal to 600. An analogous situation is with
temperature: 0 degree and 32 degrees both represent freezing on different temperature scales. Raw scores
below the passing point are converted in linear fashion to scaled scores below 600; those above the passing point
are similarly converted to scaled scores above 600.
7. Why do I need a 600 to pass the test?
The amount of knowledge required to pass the test is based on the judgments of the content experts who are
certified in the job role tested. The raw score required to pass relates to the number of correct answers that a
minimally competent (borderline) candidate would be expected to provide, and this raw score is set equal to 600
scaled score units. Different raw scores may be required of different test forms, because all examinations are not
equally difficult. The scaled score of 600 required to pass indicates that, while a different number of correct
answers may be required from one administration to the next, the passing point for all examinations represents
the same level of knowledge.

How Are Certification Exams Developed?

In response to the ACRP membership's numerous requests for professional recognition, two exam committees
were established in 1990; by 1992, the first Certification exams were developed with the assistance of a
professional testing organization. The committeesone each for CRAs and CRCsidentify areas of competency
for testing, develop appropriate test questions, and assist with validation of the exams.
It is important to note that the Academys programs are accredited by the National Commission for Certifying
Agencies, which sets internationally recognized standards for the development and operation of certification
programs. The standards assure that a program is valid, reflects current practice, and treats candidates fairly.

32

The development of Certification examinations begins with a Job Analysis, which is a survey that goes to
members of a profession to create a definitive description of the tasks required to perform a job role and the
knowledge needed in order to complete those tasks. A Job Analysis Survey is typically conducted every five to
seven years to assure the exam is testing current practice in a job role.
In 2010, the Academy updated its CRC Job Analysis with a survey sent to thousands of clinical research
professionals, 3,636 of whom responded. The results of the survey identified for the Academy what to include on
the Detailed Content Outlines (DCOs) for each job role. Those task and knowledge statements that the majority of
CRCs said were essential to their job role and that they performed frequently are covered on the exam. The
results are then incorporated into the CRC DCO.

Individuals who are already certified as a CRC are then trained to write test questions. We call these volunteers
Subject Matter Experts, or SMEs. All questions must test knowledge and skills as defined by the DCO, and
must be referenced to specific areas of ICH Guidelines, as described in our candidate handbooks. Once the

SMEs have written draft questions, the questions go to the CCRC Exam Committee for review. This process is
constantly in motion, with new questions being written, current questions being reviewed, and older or
nonperforming questions being retired from the item bank.

The CCRC Exam Committee consists of a separate group of currently practicing, certified CRCs who review,
edit, discuss, and rewrite the draft test questions. Many draft test questions are discarded in the process. Others
still are completely rewritten or heavily edited. Each question must meet minimum standards for applicability to
the job role. All Exam Committee members must agree that the answer keyed as correct is, in fact, the only
correct answer possible.
Once a draft question is approved by the Exam Committee, it then becomes a pre-test question. All questions are
pre-tested before they are counted toward a candidates score. The exams given to candidates are 125 questions
long, and 100 of them count toward the candidates score while 25 are pre-test questions. This means the
Academy is collecting statistical data on the pre-test items to see if they are well-constructed enough to appear on
the exam as a scored item. Hundreds of candidates answer a pre-test question before it can be determined if it
can be used toward a candidates score.
Once enough data have been collected, analyses are performed on the item statistics in conjunction with the
Academys professional test development partner to see if items have performed well enough to be used. If they
have not performed well (for example, if many candidates are choosing the wrong answer; or each of the four
answers is being selected equally, which indicates test-takers are guessing; or candidates who score well on the
exam overall are selecting a wrong answer), then the questions are set aside for further review and rewriting, or
they may be discarded. Only those questions that demonstrate they are fair to the test taker and identify
proficiency in a candidate are used.
Several diverse groups of CRC volunteers are used to write the questions, review the questions, select questions
to be pre-tested, and select and review questions that actually appear on the exam. The Academy follows a
process that meets international standards for test development and works with a highly regarded testing partner.
To date, more than 27,000 clinical research professionals have been Certified by the Academy. On average, 77%
of those who sit for an exam pass it.

Reliability Measurements
After every Certification exam, the Exam Committees review the results with the assistance of Prometric, one of
the testing industry's leading firms. Each item is analyzed for appropriate psychometric characteristics. Those
items with poor statistical results are reviewed by the appropriate Exam Committee to ensure that they have been
scored properly. Participant feedback regarding the exam and its contents is also reviewed and taken into
consideration when reviewing the exam and future test items.

33

Duplicate Certificates
There is a $25 charge for a duplicate certificate if the request is made more than three months after the exam.
Requests may be made in writing by completing and sending the Duplicate Certificate Form to the Academy at
[email protected].

Maintenance of
Certification

Achieve
Certification

Pass
Exam

Maintenance of Certification
by Continuing Education/Continuing Involvement
Once a candidate has achieved Certification, it is valid for two (2) years. In order to continue to be certified and to
continue to use the designation after two (2) years, certificants will need to apply for Maintenance of Certification.

The Academy requires periodic Maintenance of Certification to ensure that individuals who hold a CCRC
credential maintain their ongoing commitment to professional development in their selected area of practice.
Through the Maintenance of Certification requirements, certificants demonstrate expansion and reinforcement of
their knowledge of current practice.
The Academy supports this purpose by requiring appropriate and relevant continuing education activities to
enhance the professional development of certificants. The Maintenance of Certification program also serves to
encourage and recognize individuals who participate in ongoing professional development.
CCRCs must maintain every two (2) years from the time of original Certification. The two-year Maintenance of
Certification cycle is based on the frequency of change in the clinical research field. Maintenance of Certification
requires the completion of 24 documented hours and/or points. These points can be earned through traditional
education contact hours or through continuing involvement. Updated information is available at
www.acrpnet.org/Maintenance.

Requirements

To maintain Certification successfully, CCRC certificants must:

1. Satisfy the requirements of using one of the three (3) options listed below.
2. Document the required points on the Maintenance application (online or printable form).
3. Submit the completed application together with appropriate payment by the expiration date.*
*Incomplete submissions will be charged the late fee if not rectified by the expiration date.

34

Maintenance of
Certification
Requirements

Clinical Research
Topics
(1 hour = 1 point)

Therapeutic
Topics
(1 hour = 1 point)

Continuing
Education/Continuing
Involvement Points
(see chart)

Total Points
Required

Option 1
Contact Hours Only

At least 12 points

No more than
12 points

24

At least 8 points

No more than
13 points

No more than 12
points

24

8 Clinical Research
Topic points

6 Therapeutic
Topic points

10 Continuing
Involvement points

24

Option 2
Contact Hours and
Continuing
Involvement Points
Option 2
Example
Option 3
Examination

Pass the current form of the exam for your designation

prior to your Certification expiration date

Other Pertinent Policies and Procedures

Nondiscrimination Policy
It is ACRP/APCRs philosophy and policy to avoid discrimination based on race, color, national origin, sex, age,
religion, marital status, sexual orientation, or other status or condition that is protected by applicable law.

Confidentiality
The Academy protects the confidential information of applicants and certificants. In addition to personal
information submitted in the application, application and eligibility status and exam results are also considered
confidential. Unless otherwise required by law, confidential information will be released only to the individual
applicant/certificant unless a signed release is provided.

Verification of Credentials
An individuals Certification status may be verified through the searchable Academy registry on the ACRP website
unless that individual has opted to be excluded from this public listing. Written verification may be requested only
by contacting the Academy at [email protected], and will require a signed release from the certificant.
Only a certificants status, date of initial Certification, and designation will be disclosed.

Certification Mark Use

The Academy grants limited permission to individuals who have met all of the Certification eligibility criteria,

passed the exam, and received notification of Certification from the Academy to use the CCRC designation that
has been granted to them.

Use of the CCRC credentials by individuals who have not been granted Certification, or who have failed to
properly maintain Certification in good standing, is prohibited. Improper use of the credentials or Certification
marks may result in disciplinary or legal action.

35

The CCRC designation is federally registered intellectual property of ACRP, and use of the designations and
Certification marks is subject to approval by ACRP.

Revocation of Certification
The Academy may revoke Certification, or take other disciplinary or legal action, in the case of falsification or the
provision of misleading or incomplete information in the CV or statement of experience. ACRP may also revoke
Certification, or take other disciplinary or legal action, in the event that an individual is in violation of the
ACRP/APCR Code of Ethics and Professional Conduct or has regulatory or professional restrictions placed on
his or her clinical research practice or professional license. ACRP will adhere to due process principles. If a
certificant is notified of revocation, he or she will also be notified of the appeal process. The Discipline and
Complaints Policy and Appeals Policy is available on the ACRP website.

Policy on Appeal of Denial of Eligibility

The Academy of Clinical Research Professionals (the Academy) makes every attempt to make fair and
accurate eligibility decisions based on the information provided by the applicants. An appeal procedure is
available to any applicant who has applied for certification by the Academy and who wishes to contest any
adverse decision affecting his or her application for certification status. Any individual who does not file a
request for an appeal within the required time limit shall waive the right to appeal.
Candidates are permitted to appeal a decision made during the review of his/her application for certification.
Candidates are not permitted to appeal:
1.
2.

The passing score for the exam, or the process used to establish that passing score, which may result
in failure of the certification examination.
Existence of an eligibility requirement. The Policy on the Appeal of Denial of Eligibility provides for
appeal of the interpretation of the eligibility requirements in individual applicants circumstances.

Candidates do have the ability to appeal the content and quality of the examination, as well as questions and
answers. However, candidates may not have access to the test form, their answers, or the answer key.

Appeal Process
ll complete applications submitted for certification are afforded three (3) levels of review automatically, as part of
the standard review process. All applicants are selected by a reviewer, based on the first letter in the applicants
last name. Reviewers can communicate directly with applicants via email to obtain additional or clarifying
information to make an eligibility determination. If the first reviewer determines the candidate is ineligible, the
applicant will be notified by email with an explanation of the deficiency identified. The application is then
automatically forwarded to a second reviewer (except for cases of incomplete application/ documentation), based
on the first letter of the applicants last name.
The second reviewer begins review of the application in its entirety. The second reviewer can communicate
directly with applicants via email to obtain additional or clarifying information to make an eligibility determination.
If the second reviewer determines the candidate is ineligible, the applicant will be notified by email with an
explanation of the deficiency identified. The application is then automatically forwarded to the Director of
Certification for the final level of automatic review.
The Director of Certification reviews the application in its entirety. The Director of Certification can communicate
directly with applicants via email to obtain additional or clarifying information to make an eligibility determination.
If Director of Certification determines the candidate is ineligible, the applicant will be notified by email of the final
denial with an explanation of the deficiency identified.

36

Upon receipt of the notice of denial by the Director of Certification, the applicant has the option to submit a final,
written notice of appeal to the Academy no more than 7 (seven) days following receipt of notice of denial by the
Director of Certification.
In the written notice of appeal, the applicant shall submit additional, written, factual documentation to support
his/her appeal with an explanation of why he or she believes the reviewer(s) erred in his/her decision. No new
documents pertaining to the applicants eligibility shall be accepted during the appeals process. The applicant
shall bear the burden of proving the denial of eligibility was based on erroneous factual determination of the
reviewer.
The Academy Board of Trustees will review the candidates application and accompanying documents
and the appeal letter and make a determination within fifteen (15) days of receipt of the appeal. The
applicant will be notified via hard-copy mail of the decision of the Academy Board of Trustees within
seven (7) days of their vote and the decision shall be final.

Discipline and Complaints Policy

ACRP enforces the ACRP/APCR Code of Ethics and Professional Conductfor all CRC, CRA, CTI, and PI
certificants and individuals in the process of obtaining CRA, CRC, CTI, or PI Certification.
ACRP will investigate reported violations of the Code of Ethics and Professional Conduct. Complaints regarding
alleged violations should be reported to ACRP in writing, and should include a detailed description of factual
allegations supporting the charges and any relevant supporting documentation.
Information submitted during the complaint and investigation process is considered confidential and will be
handled in accordance with ACRPs Confidentiality policy. ACRP adheres to due process principles. Adverse
disciplinary decisions made by ACRP (or its committees) may be appealed. A complete copy of the Discipline
and Complaints Policy and Appeals Policy is available from the ACRP website.

Frequently Asked Questions (FAQs)

How will I know if my exam application was received?
An e-mail confirmation is automatically sent once payment is applied. Applicants will also be sent an e-mail that
confirms that the application has entered the eligibility review process.
NOTE: Confirmations of receipt do not confer eligibility. A separate notification will be sent regarding an
eligibility decision. Please take any necessary steps to prevent filtering of ACRP e-mails.
How will I know if I am eligible to take the exam?
An e-mail will be sent within three weeks after receipt of the application to notify you of your eligibility status or
any deficiencies that may exist.
What should I bring to the test center?
Bring two forms of appropriate identification, as described in this handbook. Online and handheld calculators will
be provided.
What happens if I need to cancel the exam?
If a candidate has already scheduled an appointment with Prometric, then:
1. Contact Prometric to cancel the appointment, at +1.800.853.6769
2. Pay the appropriate cancellation fee to Prometric (if applicable)
3. Notify the Academy in writing at [email protected] once the appointment is cancelled
If the candidate has not yet scheduled an appointment with Prometric, then the candidate should notify the
Academy in writing at [email protected].

37

If you cancel at least five (5) days prior to the exam, you will receive a refund of the exam fee ONLY. No refunds
are available fewer than five (5) days prior to the exam.
What if I need to retake the exam?
An exam may be attempted only once during each testing window. Candidates may reapply for the exam and
reattempt to take it during any future testing window.
What happens if I miss the application deadline?
All applications must be received by the Academy (not postmarked) by the application deadline. Faxed
applications will be accepted. If you miss the deadline, you may reapply when the applications become available
for the next scheduled exam date. Your application will not be returned to you.
What tools does ACRP have available to help me prepare for the exams?

As noted earlier in this handbook, the Detailed Content Outline (DCO), and therefore the content of the CCRC
exam, has been updated for exams beginning in 2012. Use the DCO to build your study plan.
An Internet-based, 50-question CRC Exam Practice Exercise is available for purchase. A CRC Exam Guide is
another resource available to assist candidates in reviewing concepts that may be found on the exam. Both the
CRC Exam Guide and the CRC Exam Practice Exercise can be purchased separately or together as a bundle
from www.acrpnet.org/examprep, the Exam Preparation web page.
What is the Academys Maintenance of Certification process?

The Academy requires periodic Maintenance of Certification to ensure that individuals who hold a CCRC
credential maintain their ongoing commitment to professional development in their selected area of practice.
Through the Maintenance of Certification requirements, certificants demonstrate expansion and reinforcement of
their knowledge of current practice.
The Academy supports this purpose by requiring appropriate and relevant continuing education activities to
enhance the professional development of certificants. The Maintenance of Certification program also serves to
encourage and recognize individuals who participate in ongoing professional development.
CCRCs must maintain every two (2) years from the time of original Certification. The two-year Maintenance of
Certification cycle is based on the frequency of change in the clinical research field. Maintenance of Certification
requires the completion of 24 documented continuing education contact hours. A minimum of 12 of the 24 hours
completed MUST be in clinical research topics. Maintenance of Certification may also be achieved by completion
of a total of 24 documented points, with a maximum of 12 points coming from continuing involvement activities,
according to the schedule below:
Authoring a journal article 4 points per article 8 points maximum
Preparing/presenting a 1-hour presentation 3 points per presentation 6 points maximum*
Authoring/presenting a half-day workshop 6 points per workshop 12 points maximum*
Authoring/presenting a 1 day workshop 12 points per workshop 12 points maximum*
*Points may be claimed only one time regardless of how many times the same program is presented.
Continuing education contact hours must be used to complete the 24-point requirement if the full 12 points of
continuing involvement are not used.
If continuing involvement activities are used for Maintenance of Certification, at least 8 of the remaining points
earned through continuing education must be in clinical research topics.
What records of continuing education or continuing involvement activities should I keep?
Copies of certificates should not be submitted with the Maintenance of Certification submission. Certificants
should retain all certificates with their records in case of selection for a random verification. The Academy will
request these records if needed. All continuing education activities submitted for Certification maintenance are

38

subject to review and approval. The Academy reserves the right to request additional information and to verify any
documentation, including academic records. Credit may be denied for continuing education activities that fail to
meet the guidelines established in this policy.
What type of contact hours may I use to maintain?
The Maintenance of Certification Handbook explains that acceptable courses for earning continuing education
contact hours include those offered by:

All state and national nursing associations;

American Council on Pharmaceutical Education (ACPE);
Accreditation Council for Continuing Medical Education (ACCME); and
Other national healthcare-related associations (respiratory therapy, medical technician, etc.)

What are examples of unacceptable continuing education contact hours?

Attendance certificates for programs that do not offer continuing education contact hours with a provider number,
as well as, for example:

CPR or BLS training courses

Blood pressure training courses
Investigator meetings that don't offer contact hours
Courses that focus on self-improvement, changes in attitude, computer skills, investments, and liberal arts

What happens if I do not maintain my Certification?

Individuals who fail to properly maintain their Certification(s) will be decertified for failure to maintain by the
specified deadline. You will receive a two-week grace period in which you may maintain with payment of a late fee
and submission of the required continuing education credits/continuing involvement. If you do not respond by the
end of the grace period, you will be decertified and will receive notification of this action.
Can I reinstate my Certification if it has expired?
A certificant who has had a credential revoked due to not meeting the Maintenance of Certification requirements
may re-apply for Certification. The individual must meet the current eligibility requirements, pay all required fees,
and successfully pass the exam.

APPENDICES
The following appendices are attached:

Appendix 1 Sample CV
Appendix 2 Request for Special Accommodations
Appendix 3 Request to Transfer Application
Appendix 4 Emergency Cancellation Request
Appendix 5 Duplicate Certificate Printing Request

39

APPENDIX 1 SAMPLE CV
Betty Smith, R.N., B.S.N.
233 ABC Drive
Arlington, VA 22314
703-555-1111
Education:
XYZ State University
Bachelor of Science in Nursing
August 2003
Clinical Research Education only required if claiming completion in lieu of 1 year of CRC experience
Name of School CCC, Program Title: ABCs of Clinical Research, Name of Organization that
Accredits the Educational Institution Providing this Program Accrediting Bureau of Health
Education Schools, Dates Attended From To 10/07 10/08
Professional Experience:
Clinical Research Coordinator
JKL Hospital
Research Department

12/1/2005 to present

Job Duties:

Assists with investigational study selection and project negotiation, including initial site/sponsor
correspondence, budget preparation, regulatory document preparations for protocol, informed
consent and appropriate HIPPA inclusions for IRB submission.
Ongoing management of study review process according to site/sponsor/IRB guidelines.
Responsible for patient screening, recruitment, consent process and enrollment for ongoing
clinical research projects, including all follow up management visits and case report form
completion.
Maintains source documentation and drug/device accountability.
Conducts staff in-services prior to implementation of new research trials.

Cardiovascular Nurse Clinician / Clinical Research Coordinator

University of XYZ Medical Center
Division of Cardiovascular Diseases

6/22/2004 to 11/30/2005

Job Duties:

Responsible for managing protocols, patient consent forms, patient screening, source
documents, recruitment and follow up management.
Completed case report forms and regulatory documents.
Participated with physician on hospital rounds and discharge teaching.
Performed noninvasive exercise and echocardiographic exercise testing.

40

APPENDIX 2

Special Accommodations Request Form

Please have this form completed by an appropriate, licensed health professional to ensure that
Prometric is able to provide a reasonable examination accommodation. The information you provide
and any documentation regarding your disability and your need for accommodation in testing will be
treated with strict confidentiality.
Please submit this form with your Certification application or fax to 703-254-8102
Attn: Certification Program by January 21, 2013

Professional Documentation:
I have known __________________________________________ since
Exam Candidate

Date

in my capacity as____________________________________. The candidate discussed with

Professional Title

me the nature of the examination to be administered. It is my opinion that because of this

candidates disability, described below, he/she should be accommodated by providing the
special arrangements as indicated.
Disability:
Please check all that apply:

Extended testing time:

hour
1 hour
Enlarged text
Other (describe):

3 hours

Accommodation is being requested for the ___CCRA ___CCRC ___CPI Exam

Exam location_______________________ _______________________ (city, state, country)
Print Name

Phone

Signed

Date

41

APPENDIX 3

Request to Transfer Exam Application to September 2013

Must be received Exam appointment is cancelled, by the Academy by 16 March 2013
The Academy offers a one-time transfer of an applicants application from one exam cycle to the
next.
There are two situations in which applicants may take advantage of this option to transfer to the
September 2013 Exam cycle:
1. If an applicant is determined Ineligible for the current exam window, but will have met the
eligibility requirements by the next exam window
2. If an applicant is determined Eligible, but must withdraw from the exam window (up to 5 days
before a scheduled exam appointment time)*
If you wish to transfer your application, you may transfer to the next exam cycle only. All fees will
become non-refundable. If for any reason you are unable to take the exam during our next exam
cycle, all fees will be forfeited.
*You must cancel your exam appointment with Prometric testing centers before submitting this
form.
Please note that if you paid the Member Rate for the exam, you will need to keep your Membership
current for the next exam cycle. If your Membership expires before the next exam cycle, you will need
to renew your Membership, or pay the difference between Member and Standard Exam Fees.
Candidate Name (printed):
Name of Exam:
Reason for Transfer:
I have read the Transfer Terms & Conditions page
I have canceled my exam appointment with Prometric (if one was scheduled) at
+1.800.853.6769.
Candidate Signature:

Date:

E-mail this form to [email protected], or fax it to +1.703.254.8102 by 16 March 2013.

42

APPENDIX 4
Emergency Exam Cancellation Form
Usually, if a candidate does not cancel his/her scheduled exam appointment at least five (5) days prior
to the scheduled date, or does not appear for the exam as scheduled, he/she forfeits all fees. However,
if a candidate will be unable to keep their exam appointment due to an emergency situation that arises
within less than five (5) days prior or the day of the scheduled exam appointment date, the Academy
may consider waiving the forfeited fee.
In order to be considered for such a waiver, the candidate is required to submit the Emergency Exam
Cancellation Form along with official supporting documentation of the emergency, to the Academy at
[email protected]. This information should be received by the Academy before the candidates
scheduled exam date, OR as soon as the emergency has passed, but NO LATER than seven (7) days after
the scheduled exam date.
The following situations will be considered:

Emergency room visit or hospitalization

Severe medical condition requiring hospitalization
Death of an immediate family member (spouse, child/dependent, parent, grandparent, sibling)
Jury duty
Call to active military duty

Notification and documentation of the emergency must be submitted by the candidate to the Academy
no later than seven (7) calendar days past the scheduled exam date.
Candidate Name: ________________________________________________
Date of Missed Exam: ________________________________________________
Reason: ________________________________________________
Supporting Document Type Attached (e.g. Emergency room release, death certificate):
___________________________________________________________________________________
____________________________________________________________________________________

Email this form and corresponding documentation to the Academy at [email protected]

NO LATER THAN SEVEN (7) DAYS AFTER THE SCHEDULED EXAM DATE.
Fax is also accepted - 703.254.8102.

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APPENDIX 5

Duplicate Certificate Request Form

Those currently holding a Certification through the Academy may request a duplicate copy of their
certificate. A $25.00 USD fee will be charged if the request is made more than three (3) months after the
original certificate was issued. If you would also like a copy of your certificate faxed or e-mailed to you,
please indicate that below.
These requests can only be made by the current certificant.

Please select all that apply:

I am requesting a duplicate certificate, and include my address and payment information below.
I am requesting that a duplicate certificate also be faxed*
I am requesting that a duplicate certificate also be e-mailed*

Certificant Name (printed): ________________________________________________

Certificant Signature: _____________________________________

Date:_____________

*Fax Number or E-mail Address: ____________________________________________

Mailing Address: ________________________________________________________
City: ________________________________State: ____

Zip code: _________

Payment Information
METHOD OF PAYMENT: Check

MC Visa AMEX

(circle one)

Credit Card Number: ______________________________________ Expiration Date: ____________

Total Amount Due $________
Please return to us via e-mail at [email protected], or fax it to 703-254-8102.

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