ICMR-Central Ethics Committee on Human Research (CECHR)

Self-checklist for ICMR Scientists

to check eligibility of project submission to ICMR-CECHR
(For ICMR internal purposes only)
This checklist will serve as a self-assessment for ICMR scientists to ascertain the suitability of their proposals for submission to ICMR-CECHR.
(If the proposal is referred with approval from DG ICMR, the applicant is eligible for ICMR-CECHR submission, irrespective of affiliation and role of the applicant)

Name of the applicant: ……………………………………………………………………………………………………………………

Designation: ………………………………………………………………………………………………………………………………………

Department: ………………………………………………………………………………………………………………………………………

Proposal Title: ……………………………………………………………………………………………………………………………………

SN Criteria Please type or tick (✓) as appropriate

ICMR headquarters
1. Affiliation1
ICMR Institutes
Principal Investigator (PI)
Role of
2.
applicant2 PI/ Co-PI & Co-ordinator
Biomedical
Clinical Trial

Observational
Research
Implementation

Epidemiological
3. Type of
Any other: ____________________
proposal
Policy/ Ethical
Guidance
Any other: ____________________

Referred by Institutional Ethics

Query Committee
or Referred with approval from DG ICMR
Referral Referral from DHR
Referral from MoHFW
Others: ______________________

1 Non ICMR Scientists are not eligible to apply

2 Sponsors/ Co-ordinator of the study are not eligible to apply
 ICMR-Central Ethics Committee on Human Research (CECHR)

Application Form for Initial Review

EC Ref. No.(for office use):

General Instructions: a) Tick or more as applicable. Mark NA if not applicable

b) Attach additional sheets of required

SECTION A- BASIC INFORMATION

1. ADMINISTRATIVE DETAILS
a) Name of Organization:
b) Name of the Ethics Committee:
c) Name of Principal Investigator:
d)Department/Division: e) Date of Submission: Click here to enter a date.

f) Type of review requested1:

Exemption from Review Expedited Review Full Committee Review

g) Title of the study:

Acronym/ Short title, (If any):

h) Protocol number (If any): Version number:
i) Details of Investigators:
Name Designation and Qualification Department and Address for communication2
Institution
Principal Investigator/Guide

Co-investigator/student/fellow

j) Number of studies where applicant is a:

i)Principal Investigator at time of submission:

ii) Co-Investigator at time of submission:

k) Duration of the study:

2. FUNDING DETAILS AND BUDGET

a) Total estimated budget for site:

At site In India Globally

b)Self-funding Institutional funding Funding agency (Specify)

 SECTION B - RESEARCH RELATED INFORMATION
3. OVERVIEW OF RESEARCH
a) Lay Summary3 (within 300 words)

(b) Type of study:

Basic Sciences Clinical Cross Sectional
Retrospective Epidemiological/ Public Health Case Control
Prospective Socio-behavioural Cohort
Qualitative Biological samples/Data Systematic Review
Quantitative Mixed Method
Any others (Specify)

4. METHODOLOGY
a) Sample size/ No. of Participants (as applicable)

At site In India Globally

Control group Study Group
Justification for the sample size chosen (100 words); In case of qualitative study, mention the criteria used for saturation

b) Is there an external laboratory/ outsourcing involved for investigations? 4 Yes No NA

c) How was the scientific quality of the study assessed?

Independent external review Review by Sponsor/Funder Review within PI’s institution

Review within multi-centre research group No Review

Date of review: Click here to enter a date.

Comments of Scientific Committee, if any(100 words)

SECTION C - PARTICIPANT RELATED INFORMATION

5. RECRUITMENT AND RESEARCH PARTICIPANTS
a) Type of participants in the study:

Healthy volunteer Patient Vulnerable person/ Special groups

Others (Specify)
Who will do the recruitment?
Participant recruitment methods used:

Posters/ leaflets/Letters TV/Radio ads/Social media/Institution website

Patients / Family/Friends visiting hospitals Telephone

Others(Specify)

b) i. Will there be vulnerable person/special groups involved? Yes No NA

ii) If yes, type of vulnerable person /special groups

Children under 18 yrs Pregnant or lactating women

Differently abled (Mental/Physical) Employees/Students/Nurses/Staff

Elderly Institutionalized

Economically and socially disadvantaged Refugees/Migrants/Homeless

Terminally Ill (stigmatized or rare diseases)

Any other (Specify):
iii) Provide justification for inclusion/exclusion

iv) Are there any additional safeguards to protect research participants?

c) Is there any reimbursement to the participant? Yes No

If yes, Monetary Non-monetary Provide details

d) Are there any incentives to the participant? Yes No

If yes, Monetary Non-monetary Provide details

e) Are there any participant recruitment fees/ incentives for the study provided to the PI/ Institution?

If yes, Monetary Non-monetary Provide details Yes No

6.BENEFITS AND RISKS

a) i. Are there any anticipated physical/social/psychological discomforts/ risk to participants? Yes No

If yes, categorize the level of risk5:
 Less than Minimal risk Minimal risk

Minor increase over minimal risk or Low Risk More than Minimal Risk or High Risk
ii) Describe the risk management strategy:

b) What are the potential benefits from the study? Yes No If yes, Direct Indirect

For the participant

For the society/community

For improvement in science

Please describe how the benefits justify the risks

c) Are Adverse Events expected in the study6? Yes No NA

Are reporting procedures and management strategies described in the study? Yes No
If Yes, Specify
7. INFORMED CONSENT

a) Are you seeking waiver of consent? If yes, please specify reasons and skip to item no. 8 Yes No

b) Version number and date of Participant Information Sheet (PIS):

Version number and date of Informed Consent Form (ICF):
c) Type of consent planned for :
Signed consent Verbal/Oral consent Witnessed consent Audio-Video (AV) consent

Consent from LAR (If so, For children <7 yrs Verbal assent from o minor Written assent from o minor (13-18
specify from whom) parental/ LAR Consent (7-12 yrs)along with yrs) along with parental consent
parental consent

Other (specify)

d) Who will obtain the informed consent?

PI/Co-I Nurse/Counselor Research Staff Other(Specify)

Any tools to be used

e) Participant Information Sheet(PIS) and Informed Consent Form (ICF)

English Local language other (specify)

List the languages in which translations were done

 If translation has not been done, please justify

f) Provide details of Consent requirement for previously stored samples if used in the study 7
g) Elements contained in the Participant Information Sheet(PIS) and Informed Consent Form (ICF)
Simple language Data/ Sample sharing Compensation for study
related injury
Risks and discomforts Need to recontact Statement that consent is
voluntary
Alternatives to participation Confidentiality Commercialization/benefit
sharing
Right to withdraw Storage of samples Statement that study
involves research
Benefits return of research results Use of photographs/
identifying data
Purpose and procedure Payment for participation Contact information of PI
and Member Secretary of
EC
Others(Specify)
8. PAYMENT/COMPENSATION
a) Who will bear the costs related to participation and procedures8?

PI Institution Sponsor Other agencies(specify)

b) Is there a provision for free treatment of research related injuries? Yes No NA

If yes, then who will provide the treatment?

c) Is there a provision for compensation of research related SAE? If yes, specify. Yes No NA

Sponsor Institution/ Corpus funds Project grants Insurance

d) Is there any provision for medical treatment or management till the relatedness is determined for injury to the

participants during the study period? If yes, specify. Yes No NA

e) Is there a provision for ancillary care for unrelated illness during the study period? If yes, please
specify.

Yes No NA
9. STORAGE AND CONFIDENTIALITY
a) Identifying Information: Study Involves samples/data. If Yes, Specify Yes No NA

Anonymous/unidentified Anonymized: reversibly coded Irreversibly coded Identifiable

If identifiers must be retained, what additional precautions will be taken to ensure that access is limited / data is
safeguarded? (e.g. data stored in a cabinet, password protected computer etc.)
b) Who will be maintaining the data pertaining to the study?
c) Where will the data be analyzed9 and by whom?
d) For how long will the data be stored?

e) Do you propose to use stored samples/data in future studies? Yes No Maybe

If yes, explain how you might use stored material/data in the future?

SECTION D: OTHER ISSUES

10. PUBLICATION, BENEFIT SHARING AND IPR ISSUES

(a) Will the results of the study be reported and disseminated? If yes, specify. Yes No NA

(b) Will you inform participants about the results of the study? Yes No NA

(c) Are there any arrangements for continued provision of the intervention for participants, if effective, once the study

has finished? If yes describe in brief (Max 50 words) Yes No NA

(d) Is there any plan for post research benefit sharing with participants? If yes, specify

Yes No NA

(e) Is there is any commercial value or a plan to patent/IPR issues. If yes, Please provide details

Yes No NA

(f) Do you have any additional information to add in support of the application, which is not included elsewhere in the
form? If yes, provide details.

Yes No

SECTION E: DECLARATION AND CHECKLIST 10

11. DECLARATION (Please tick as applicable)
I/We certify that the information provided in this application is complete and correct.
I/We confirm that all investigators have approved the submitted version of proposal/related documents.
I/We confirm that this study will be conducted in accordance with the latest ICMR National Ethical Guidelines for
Biomedical and Health Research involving Human Participants and other applicable regulations and guidelines.
 I/We confirm that this study will be conducted in accordance with the Drugs and Cosmetics Act 1940 and its Rules
1945 as amended from time to time, GCP guidelines and other applicable regulations and guidelines.
I/We will comply with all policies and guidelines of the institute and affiliated/collaborating institutions where this
study will be conducted.
I/We will ensure that personnel performing this study are qualified, appropriately trained and will adhere to the
provisions of the EC approved protocol.
I/We declare that the expenditure in case of injury related to the study will be taken care of.
If applicable, I/We confirm that an undertaking of what will be done with the leftover samples is provided, if
applicable.
I/We confirm that we shall submit any protocol amendments, adverse events report, significant deviations from
protocols, progress reports (if required) and a final report and also participate in any audit of the study if needed.
I/We confirm that we will maintain accurate and complete records of all aspects of the study.
I/We will protect the privacy of participants and assure safety and confidentiality of study data and biological
samples.
I/We hereby declare that I/any of the investigators, researchers and/or close relative(s), have no conflict of interest
(Financial/Non-Financial) with the sponsor(s) and outcome of study.
I/We have the following conflict of interest (PI/Co-PI):
1.
2.
I/We declare/confirm that all necessary government approvals will be obtained as per requirements wherever
applicable.

Name of PI: Signature: Click here to enter a date.

Name of Co-PI: Signature: Click here to enter a date.

Name of Guide: Signature: Click here to enter a date.

Name of HOD: Signature: Click here to enter a date.

12. CHECKLIST
S.No Items Yes No NA Enclosure No. EC Remarks
(If applicable)
ADMINISTRATIVE REQUIREMENTS
1. Cover letter
 2. Brief CV of all Investigators
3. Good Clinical Practice (GCP) training
of investigators in last 3 years
4. Approval of Scientific Committee
5. EC clearance of other centers*
6. Agreement between collaborating
partners*
7. MTA between collaborating
partners*
8. Insurance policy/certificate
9. Evidence of external laboratory
credentials in case of an externally
outsourced laboratory study QA/QC
certification
10. Copy of contract or agreement
signed with the sponsor or donor
agency
11. Provide all significant previous
decisions (e.g. those leading to a
negative decision or modified
protocol) by other ECs/Regulatory
authorities for proposed study
(whether in same location or
elsewhere) and modification(s) to
protocol
PROPOSAL RELATED
12. Copy of the detailed protocol11
13. Investigators Brochure (If applicable
for drug/biologicals/device trials)
14. Participant Information Sheet (PIS)
and Informed Consent Form
(ICF)(English and translated)
15. Assent form for minors (12-18 years)
(English and Translated)
16. Proforma/Questionnaire / Case
Report Forms (CRF)/ Interview
guides/ Guides for Focused Group
Discussions (FGDs) (English and
translated)
17. Advertisement/material to recruit
participants (fliers, posters etc)
PERMISSION FROM GOVERNING AUTHORITIES
Other Registration/ permissions Required Not Received Applied EC Remarks
Required dd/mm/yy
18. CTRI Enter date
19. DCGI Enter date
20. HMSC Enter date
21. NAC-SCRT Enter date
22. ICSCR Enter date
23. RCGM Enter date
24. GEAC Enter date
25. BARC Enter date
26. Tribal Board Enter date
 27. Others (Specify) Enter date
ANY OTHER RELEVANT INFORMATION/DOCUMENTS RELATED TO THE STUDY
Item YES NO NA Enclosure no. EC remarks
28.
29.

1Refer to National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017 on Page 36 Table 4.2. for types
of review
2Include telephone/mobile, fax numbers and email id

3Summarize in the simplest possible way such that a person with no prior knowledge of the subject can easily understand it.

4If participant samples are sent outside for investigations, provide details of the same and attach relevant documentation such as an MTA /

MoU
5For categories of risk refer to National Ethical Guidelines for Biomedical & Health Research Involving Human Participants 2017, Page 6 Table

2.1
6The term adverse events in this regard encompass both serious and non-serious adverse events.

7Information on re-consent requirements can be found at National Ethical Guidelines for Biomedical and Health Research Involving Human

Participants 2017, Page 54 in Section 5.8.

8Enclose undertaking from PI confirming the same

9For example, a data entry room, a protected computer etc.

10These formats are adaptable and can be modified by the Ethics Committee members depending on their needs and requirements

Acknowledgement for Receipt of Application (Copy to be provided to PI)

*For multicentre research. MTA-Material transfer agreement; CTRI-Clinical Trial Registry-India; DCGI-Drug Controller General of India; HMSC-
Health Ministry’s Screening Committee; NAC-SCRT- National Apex Committee for Stem Cell Research and Therapy; IC-SCR-Institutional
committee for Stem Cell Research; RCGM- Review Committee on Genetic Manipulation; GEAC- Genetic Engineering Approval Committee;
BARC- Bhabha Atomic Research Centre
11Refer to National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017, section 4 Page no. 35 Box

4.4(b)
 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 1)
Application Form for Expedited Review
EC Ref. No. *(for office use):

Title of study:
Principal Investigator (Name, Designation and Affiliation):
1. Choose reasons why expedited review from EC is requested12?
i. Involve non-identifiable specimen and human tissue from sources like blood banks, tissue banks
and left-over clinical samples
ii. Involve clinical documentation materials that are non-identifiable (data, documents, records).
iii. Modification or amendment to approved protocol (administrative changes/correction of
typographical errors and change in researcher(s))
iv. Revised proposals previously approved through expedited review, full review or continuing
review of approved proposals
v. Minor deviations from originally approved research causing no risk or minimal risk
vi. Progress/annual reports where there is no additional risk, for example activity limited to data
analysis. Expedited review of SAEs/unexpected AEs will be conducted by SAE subcommittee.

vii. For multicentre research where a designated EC has approved the proposal, a participating EC
may review participating centre specific information and modification in the study proposal
through full committee meeting/ expedited review depending on the importance of local
consent related issues involved specific to the centre.
viii. Research during emergencies and disasters (See Section 12 of ICMR Ethical Guidelines, 2017).

ix. Any other (please specify)

2. Is waiver of consent being requested ? Yes No

3. Does the research involve vulnerable person13? Yes No

If Yes give details:

Signature of PI: Click here to enter a date.

Comments of EC Secretariat:

Signature of Member Secretary: Click here to enter a date.

12
Refer to National Ethical Guidelines for Biomedical & Health Research Involving Human Participants 2017, Page 51 Table 4.2
13For details, refer to application for initial review, Section-C, 5(b)
*In case this is first submission, leave it

blank
 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 2)
Application Form for Exemption from Review
………………………………………………………………………………………………………………
(Name of the Institution) EC Ref. No.(for office use):

Title of study:
Principal Investigator (Name, Designation and Affiliation):
1. Choose reasons why exemption from ethics review is requested 14?
i. Research on data in the public domain/ systematic reviews or meta-analyses;
ii. Observation of public behavior/ information recorded without linked identifiers and disclosure
would not harm the interests of the observed person
iii. Quality control and quality assurance audits in the institution
iv. Comparison among instructional techniques, curricula, or classroom management methods

v. Consumer acceptance studies related to taste and food quality

vi. Public health programmes by government agencies 15
vii. Any other (please specify in 100 words):

Signature of PI: Click here to enter a date.

Comments of EC Secretariat:

Signature of Member Secretary: Click here to enter a date.

14Selectthe category that applies best to your study and justify why you feel it should be exempted from review. For a detailed
understanding of the type of studies that are exempt from review, refer to National Ethical Guidelines for Biomedical & Health Research
Involving Human Participants 2017, Page 51 Table 4.2.

15Suchas programme evaluation where the sole purpose of the exercise is refinement and improvement of the programme or monitoring
(where there are no individual identifiers)
 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 3)
Continuing Review/ Annual report format
EC Ref. No. (for office use):

Title of study:
Principal Investigator (Name, Designation and Affiliation):
1.
CECHR Reference No.: --- ----
2.
Date of EC Approval: Click here to enter a date. Duration of Approval months/ years
3.
Date of Start of study: Click here to enter a date. Proposed date of Completion: Click here to enter a date.

Period of Continuing Report Click here to enter a date. To Click here to enter a date.
4. Does the study involve recruitment of participants? Yes No
(a) If yes, Total number expected No. Screened: No. Enrolled:

Number Completed: No. on followup: .

(b) Enrolment status – ongoing / completed/ stopped

(c) Report of DSMB16 Yes No NA

(d) Any other remark

(e) Have any participants withdrawn from this study since the last approval? Yes No NA
If yes, total number withdrawn and reasons:
5. Is the study likely to extend beyond the stated period17? Yes No
If yes, please provide reasons for the extension
6. Have there been any amendments in the research protocol/informed consent document (ICD) during the
past approval period?
If No, skip to item no.6 Yes No
(a) If yes, date of approval for protocol and ICD : Click here to enter a date.

(b) In case of amendments in the research protocol/ICD, was re-consent sought from participants?
If yes, when / how: Yes No

16In
case there is a Data Safety Monitoring Board (DSMB) for the study provide a copy of the report from the DSMB. If not write NA.
17
Problems encountered since the last continuing review application with respect to implementation of the protocol as cleared by the EC

7. Is any new information available that changes the benefit -risk analysis of human participants involved
in this study? Yes No
If yes, discuss in detail:
8. Have any ethical concerns occurred during this period? Yes No
If yes, give details
9. (a) Have any adverse events been noted since the last review? Yes No

Describe in brief:
(b) Have any SAE’s occurred since last review? Yes No
If yes, number of SAE’s : Type of SAE’s:
(c) Is the SAE related to the study? Yes No
Have you reported the SAE to EC? If no, state reasons Yes No

10. Has there been any protocol deviations/violations that occurred during this period?
If yes, number of deviations
Have you reported the deviations to EC? If no, state reasons Yes No

11. In case of multicentric trials, whether reports of off-site SAEs have been submitted to the EC
Yes No NA
12. Are there any publications or presentations during this period? If yes give details Yes No

13. Brief Summary of the Study (up to 500 words) (to briefly describe the status, findings, activities
undertaken, any deviations or changes, special mentions etc.)

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 4)
Application/ Notification form for Amendments
EC Ref. No.(for office use):

18
Location implies page number in the ICD/protocol where the amendment is proposed.
Title of study:
Principal Investigator (Name, Designation and Affiliation):

1. Date of EC approval: Click here to enter a date. Date of start of study: Click here to enter a date.

2. Details of amendment(s)

S.No Existing Provision Proposed Amendment Reason Location in the

protocol/ICD18

3. Impact on benefit-risk analysis Yes No

If yes, describe in brief:

4. Is any re-consent necessary? Yes No

If yes, have necessary changes been made in the informed consent? Yes No

5. Type of review requested for amendment:

Expedited review (No alteration in risk to participants)
Full review by EC (There is an increased alteration in the risk to participants)

6. Version number of amended Protocol/Investigator’s brochure/ICD:

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 5)
Protocol Violation/ Deviation Reporting form
(Reporting by case)
EC Ref. No.(for office use):

1. Title
EC approval
of study:date: Click here to enter a date. Date of start of study: Click here to enter a date.

2. Principal Investigator
Participant ID: (Name, Designation and Affiliation):
Date of occurrence: Click here to enter a date.

3. Total number of deviations /violations reported till date in the study:

4. Deviation/Violation identified by: Principal Investigator/study team Sponsor/Monitor

SAE Sub Committee/EC
5. Is the deviation related to (Tick the appropriate box) :
Consenting Source documentation
Enrollment Staff
Laboratory assessment Participant non-compliance
Investigational Product Others (specify)
Safety Reporting

6. Provide details of Deviation/Violation:

7. Corrective action taken by PI/Co-PI:

8. Impact on (if any): Study participant Quality of data

9. Are any changes to the study/protocol required? Yes No

If yes, give details

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 6)
Serious Adverse Event Reporting Format
(Biomedical Health Research)
EC Ref. No.(for office use):

Title of study:

Principal Investigator (Name, Designation and Affiliation)

1. Participant details :
Initials and ID Age at the time of Gender Weight: (Kgs)
event Male Female
Height: (cms)
2. Suspected SAE diagnosis:

3. Date of onset of SAE: Click here to enter a date. Describe the event19:

Date of reporting SAE: Click here to enter a date.

4. Details of suspected intervention causing SAE20

5. Report type: Initial Follow-up Final

If Follow-up report, state date of Initial report Click here to enter a date.

6. Have any similar SAE occurred previously in this study? If yes, please provide details. Yes No

7. In case of a multi-centric study, have any of the other study sites reported similar SAEs (Please list
number of cases with details if available).

8. Tick whichever is applicable for the SAE: (Kindly note that this refers to the Intervention being
evaluated and NOT disease process)

9. A. Expected event Unexpected event

B.
Hopitalization Increased Death Congenital
Hospital Stay anomaly/birth
defect
Persistent or Event requiring Event which Others
significant intervention poses threat to
disability/incap (surgical or life
acity medical) to
prevent SAE
 C. No permanent/significant functional/cosmetic impairment

Permanent/significant functional/cosmetic impairment

Not Applicable
9. Describe the medical management provided for adverse reaction (if any) to the research
participants. (include the information on who paid, how much was paid and to whom)

10. Proide details of compensation provided/ to be provided to participants (include the information
on who paid, how much was paid and to whom)

11. Outcome of SAE

Fatal Recovered
Continuing Unknown
Recovering others(specify)
12. Provide any other relevant information to that can facilitate assessment of the case such as
medical history

13. Provide details about PI’s final assessment of SAE relatedness to trial.

Signature of PI: Click here to enter a date.

20Refers to research intervention including basic, applied and operational research or clinical research, except for investigational new drugs.
If it is an academic clinical trial, mention name, indications, dosage, form and strength of the drug(s)
19Duration, setting, site, signs, symptoms, severity, criteria for regarding the event serious
 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 7)
Premature Termination/ Suspension/Discontinuation
Report Format
EC Ref. No.(for office use):

Title of study:
Principal Investigator (Name, Designation and Affiliation):

1. Date of EC Approval: Click here to enter a date. Date of start of study: Click here to enter a date.
2. Date of Last Progress Report Submitted to EC: Click here to enter a date.

3. Date of Termination/suspension/discontinuation: Click here to enter a date.

4. Tick the appropriate

Premature Termination Suspension Discontinuation
Reason for Termination/Suspension/Discontinuation:
Action taken Post Termination/ Suspension/Discontinuation:

5. Plans for post study follow up/withdrawal21 (if any):

6. Details of study participants:

Total participants to be recruited: Screened: Screen failures:

Enrolled: Consent Withdrawn: Reason(Give details):

Withdrawn by PI: Reason(Give details):

Active on treatment: Completed treatment : Participants on Follow-up:

Participants lost to follow up: Any other: No. of drop outs:

Reasons for each drop-out:

7. Total Number of SAEs reported till date in the study:

Have any unexpected adverse events or outcomes observed in the study been reported to the EC?
Yes No
8. Have there been participant complaints or feedback about the study? Yes No
If yes, provide details

21 Describe post-termination/suspension/ discontinuation follow up plans if any. Also describe any withdrawal plans for the study.
9. Have there been any suggestions from the SAE Sub Committee? Yes No
If yes, have you implemented that suggestion? Yes No
10. Do the procedures for withdrawal of enrolled participants take into account their rights and welfare?
(e.g., making arrangements for medical care of research participants): If yes, provide details
Yes No

Summary of Results (if any):

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 8)
Application form for Clinical Trials
EC Ref. No.(for office use):

Title of study:

Principal Investigator (Name, Designation and Affiliation) :

1. 1. 3. Type of clinical trial Regulatory trial Academic trial

2.
CTRI registration number: NABH accreditation number EC registration number:
4. 2. If regulatory trial, provide status of CDSCO permission letter

Approved and letter attached

Applied, under process

Not applied (State reason)
5. 3. Tick all categories that apply to your trial
6.
Phase - I Phase II
Phase III Phase IV or Post Marketing Surveillance
Investigational medicinal products Investigational New drug
Medical devices New innovative procedure
Drug/device combination Bioavailability/Bioequivalence studies
Non-drug intervention Repurposing an existing intervention
Indian system of medicine (AYUSH) Stem cells
Phytopharmaceutical drug Approved drug for any new indication or new
route of administration
Phase - I Phase II

Others (specify)

.4 Trial design of the study (May choose more than one)

Randomized Factorial
Non randomized Stratified
Parallel Adaptive
Cross-over Comparison trial
Cluster Superiority trial
Matched-pair Non-inferiority trial
 Others (specify) Equivalence trial

ii. If there is randomization, how will the participants be allocated to the control and study group(s)?

II. Describe the method of allocation concealment (blinding / masking), if applicable

List the primary / secondary outcomes of the trial.

7. 6. Is there a Contract Research Organization (CRO) /Site Management Organisation (SMO) / Any Other
Agency such as public relation/Human resource? Yes No
If yes, Name and Contact details:
State how the CRO/SMO/agency will be involved in the conduct of the trial (tick all that apply)
Project management Clinical and medical monitoring
Regulatory affairs Data management
Statistical support Medical writing
Site management Audits, quality control, quality assurance
Finance management Recruitment and training
Administrative support Others (specify)

7. Please provide the following details about the intervention being used in the protocol
I. Drug/s, device/s and/or biologics; If yes, provide regulatory approval details
Yes No NA

II. Already approved drugs or a combination of two or more drugs with new indications / change in
dosage form / route of administration. If yes, provide details Yes No NA

III. Provide contact details of who prepared and /or is manufacturing the drug/s, device/s and biologics

IV. Provide details of patent of the drug/s, device/s and biologics.

8. Describe in brief any preparatory work or site preparedness for the protocol? Yes No NA
If yes, (100words)

9. Is there an initial screening/ use of existing database for participant selection? Yes No NA
If Yes, provide details22
10. Are there any anticipated incidence, frequency and duration of adverse events related to the
intervention? If yes, provide details of arrangements made to address them. Yes No NA

11. Does the study use a placebo?

If yes, justify the use of the placebo and risks entailed to participants. Yes No NA

12. Will current standard of care be provided to the control arm in the study? Yes No NA
If no, please justify.

13. Are there any plans to withdraw standard therapy during the study ?If yes, please justify.
Yes No NA

14. Are there any rules to stop the protocol in case of any adverse events? If yes, please specify.
Yes No NA

15. Does the study have a Data and Safety Monitoring Plan? If no, please justify. Yes No

16. Participant Information Sheet(PIS) and Informed Consent Form (ICF)

English Local language Other(Specify)
(Certified that local version (s) is/are
a true translation of the English
version and can be easily
understood by the participants)
List the languages in which translations were done
Justify if translation not done
22
In order to select participants for your protcol does the protocol require you to screen an initial population or refer to an existing database
before shortlisting participants. If yes, provide details on the same

17. Involvement/consultation of statistician in the study design Yes No NA

18. Is there any insurance coverage of the trial? If yes, provide details. Yes No

i. Is the PI registered with Medical Council of India (MCI) or the State Medical Council registration?
Please provide details. Yes No

ii. Is the PI trained in GCP in last 3 years?. If yes, Please enclose certificate Yes No

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 9)
Serious Adverse Event Reporting Format (Clinical trials)
EC Ref. No. (for office use):

Title of study:
Principal Investigator (Name, Designation and Affiliation):
1. Participant details :

Initials and Case Age at the time of event Gender Weight: (Kgs)
No./Subject ID
Male Height: (cms)
Female

2. Report type: Initial Follow-up Final

If Follow-up report, state date of Initial report Click here to enter a date.

What was the assessment of relatedness to the trial in the initial report?

By PI- Related By sponsor - Related By EC - Related

Unrelated Unrelated Unrelated

3. Describe the event and specify suspected SAE diagnosis:

4. Date of onset of SAE: Click here to enter a date. Date of reporting: Click here to enter a date.

5. Onset lag time after administration of intervention: Location of SAE (Clinic/Ward/Home/Other)

6. Details of suspected study drug/device/investigational procedure causing SAE:

I. Suspect study drug (include generic name) device/intervention:

II. Indication(s) for which suspect study drug was prescribed or tested:
III. Route(s) of administration, daily dose and regimen, dosage form and strength:
IV. Therapy start date: Click here to enter a date. Stop date: Click here to enter a date.

7. Was study intervention discontinued due to event? Yes No

8. Did the reaction decline after stopping or reducing the dosage of the study drug / procedure?
Yes No

If yes, provide details about the reduced dose.

9. Did the reaction reappear after reintroducing the study drug / procedure? Yes No NA

If yes, provide details about the dose.

10. Concomitant study drugs history and lab investigations:

 I. Concomitant study drug (s) and date of administration: Click here to enter a date.

II. Relevant test/laboratory data with dates:Click here to enter a date.

III. Patient relevant history including pre-existing medical conditions (e.g. allergies, race, pregnancy,
smoking, alcohol use, hepatic/ renal dysfunction etc)

11. Have any similar SAE occurred previously in this study? If yes, please provide details. Yes No

12. Seriousness of the SAE:

Death Congenital anomaly

Life threatening Required intervention to prevent

permanent impairment / damage
Hospitalization-initial or prolonged
Others (specify)
Disability

13. Describe the medical management provided for adverse reaction (if any) to the research participant.
(Include information on who paid, how much was paid and to whom).

14. Outcome of SAE:

Fatal Recovered
Continuing Unknown
Recovering Other (specify)

15. Was the research subject continued on the trial? Yes No NA

16. Provide the details about PI final assessment of SAE relatedness to trial.

17. Has this information been communicated to sponsor/CRO/regulatory agencies? Yes No

Provide details if communicated (including date)

18. Does this report require any alteration in trial protocol? Yes No

19. Provide details of compensation provided/ to be provided the participants (include information on who
pays, how much, and to whom)

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 10)
Application Form for Human Genetics Testing Research
EC Ref. No.(for office use):

Title of study:

Principal Investigator (Name, Designation and Affiliation)

1. Describe the nature of genetic testing research being conducted.
(e.g.- screening/gene therapy/newer technologies/human embryos/foetal autopsy)

2. Does the study involve pretest and post-test counselling? If yes, please describe. Yes No NA

3. Explain the additional safeguards provided to maintain confidentiality of data generated.

4. If there is a need to share the participants’ information/investigations with family/community, is it addressed

in the informed consent? Yes No NA

If findings are to be disclosed, describe the disclosure procedures (e.g. genetic counseling)

5. Is there involvement of secondary participants? Yes No NA

If yes, will informed consent be obtained? State reasons if not. Yes No NA

6. What measures are taken to minimize/ mitigate/eliminate conflict of interest?

7. Is there plan for future use of stored sample for research? Yes No

If yes, has this been addressed in the informed consent. Yes No

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 11)
Application Form for Socio-Behavioural and Public
Health Research
EC Ref. No.(for office use):

Title of study:

Principal Investigator (Name, Designation and Affiliation)

1. Data collection method used in the study

Focus group Questionnaire/survey Observation

Interviews Documents and records Ethnographies/oral

history/case studies

Others(Specify)

If it is an interview, will there be audio-video recording of participants’ interview? If yes, justify the
reasons and storage strategies. Yes No

2. Type of informed consent is used in the study?

Individual consent Gate-keeper consent Community consent

Others (specify)

3. Provide details of safeguards to ensure privacy and confidentiality of participants in the event of data
sharing? Yes No

4. Describe strategies to manage if any patterns of behavior of self-harm or harm to the society are
identified.(e.g.: Suicide or infanticide) Yes No NA

5. Are cultural norms and/or social considerations/sensitivities taken into account while designing the
study and participant recruitment? Yes No

6. Is there a use of an interpreter? If yes, describe the selection process. Yes No NA

7. Describe any preparatory work or site preparedness for the study Yes No NA

8. I. Type of risk related to procedures involved in the study

Potentially harmful
 Describe the risk minimization strategies.

II. Justify reasons if individual harm is overriding societal benefit. Yes No NA

III. Describe how do societal benefits outweigh individual harm.

9. Does the study use incomplete disclosure or active deception or authorized deception? If yes, provide
details and rationale for deception. Yes No

10. Describe the debriefing process that will be used to make participants aware of the incomplete
disclosure or deception, including their right to withdraw any record of their participation.

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 12)
Study completion/ Final report format
EC Ref. No.(for office use):

Title of study:
Principal Investigator (Name, Designation and Affiliation)
1. Date of EC Approval: Click here to enter a date.

2. Date of Start of Study: Click here to enter a date. Date of study completion:Click here to enter a date.
Date of Start of Study: Click here to enter a date. Date of study completion:Click here to enter a date.

3. Provide details of:

a) Total no. of study participants approved by the EC for recruitment:
b) Total no. of study participants recruited:
c) Total number of participants withdrawn from the study (if any):
Provide the reasons for withdrawal of participants23:

4. Describe in brief the publication/ presentation/dissemination plans of the study findings. (Also,
mention if both positive and negative results will be shared)

5. Describe the main Ethical issues encountered in the study (if any)

6. State the number (if any) of Deviations/Violations/ Amendments made to the study protocol during the
study period
Deviations: Violation: Amendments:
7. Describe in brief Plans for archival of records / Record Retention:
8. Is there a plan for post study follow-up Yes No
If yes, describe in brief:
9. Do you have plans for ensuring that the data from the study can be shared/ accessed easily?

If yes, describe in brief: Yes No

10. Is there a plan for post study benefit sharing with the study participants? Yes No
If yes, describe in brief:

11. Describe results (summary) with Conclusion24:

12. Number of SAEs that occurred in the study:

13. Have all SAEs been intimated to the EC: Yes No

14. Is medical management or compensation for SAE provided to the participants? Yes No
If yes, provide details
Signature of PI: Click here to enter a date.

24 For sponsored studies, if the final report is not available from sponsor, it may be submitted later to the EC once it is ready.
23 Explanation for the withdrawal of participants whether by self or by the PI
 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 13)
Format for Curriculum Vitae for Investigators
……………………………………………………………………………………
(Name of the Institution) EC Ref. No.(for office use):

Name:

Present affiliation(Job title, department, and organisation):

Address(Full work address):

Telephone number: Email address:

Qualifications:

Professional registration (Name of body, registration number and date of registration):

Previous and other affiliations(Include previous affiliations in the last 5 years and other current affiliations):

Projects undertaken in the last 5 years:

Relevant research training/experience in the area25:

Relevant publications (Give references to all relevant publications in the last five years):

Date: Click here to enter a date.

Signature

25
Details of any relevant training in the design or conduct of research, for example in the Ethics Training, Human participants’ protection
courses, Clinical Trials Regulations, Good Clinical Practice, consent, research ethics training or other training appropriate to non-clinical
research. Give the date of the training
 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 14)
Project extension form
EC Ref. No. (for office use):

*The project extension must be duly submitted no later than 30 days before the approval expires.

Title of study:

Principal Investigator (Name, Designation and Affiliation)

1. CECHR Reference No.: CECHR ---- / ----

2. Date of EC Approval: Click here to enter a date. Duration of Approval months/ years

3. Date of Start of study: Click here to enter a date. Date of Completion: Click here to enter a date.

(As per the first approval granted)

Duration of Extension sought: months/ years

Period of Extension sought from Click here to enter a date. To Click here to enter a date.
Have there been any modifications in the budget for the extension sought?
4.
If No, skip to item no.5 Yes No

If yes, discuss in detail:

Does the study involve recruitment of participants? Yes No

5.

(f) If yes, Total number for study No.

(g) Screened: No. Enrolled: No.
(h) Number Completed: No. on followup: No.
(i) Enrolment status – ongoing / completed/ stopped No.
(j) If ongoing , Expected No.

(k) Report of DSMB* Yes No

NA
* In case there is a Data Safety Monitoring Board (DSMB) for the study provide a copy of the report from the DSMB. If not write NA.
(l) Any other remark

(m) Have any participants withdrawn from this study since the last approval? Yes No NA

If yes, total number withdrawn and reasons:

6. Have there been any amendments in the research protocol/informed consent document (ICD) for the

extension sought? Yes No

If No, skip to item no.7

(a) If yes, discuss in detail:

(b) In case of amendments in the research protocol/ICD, will re-consent be sought from
participants?
If yes, when / how: Yes No

7. Is any new information available that changes the benefit -risk analysis of human participants involved

in this study? Yes

No
If yes, discuss in detail:
8. Have any ethical concerns occurred during the study? Yes No

If yes, give details

9. (a) Have any adverse events been noted since the last review? Yes No

Describe in brief:

(b) Have any SAE’s occurred since last review? Yes No

If yes, number of SAE’s : Type of SAE’s:

(c) Is the SAE related to the study? Yes No

Have you reported the SAE to EC? If no, state reasons Yes No

10. Is any new information available that changes the benefit -risk analysis of human participants involved
in this study?
If yes, discuss in detail:

Have any ethical concerns occurred during the study? Yes No

11. In case of multicentric trials, whether reports of off-site SAEs have been submitted to the EC

Yes No NA
12. Are there any publications or presentations during this period? If yes give details Yes No

13. Briefly explain the reason for the extension sought (up to 500 words) (Please attach the relevant
documents in support of the extension.)

Signature of PI: Click here to enter a date.

 ICMR-Central Ethics Committee on Human Research (CECHR)
(Annexure 15)
Initial Review Form for Multicentric Research
EC Ref. No. (for office use):
PART 1 (To be filled by coordinating PI)

General Instructions:
a) Tick one or more as applicable. Mark NA if not applicable. Attach additional sheets if required
b) For submission to Designated Ethics Committee and to be shared with PIs at Participating Centres

SECTION B – RESEARCH-RELATED INFORMATION

SECTION A - BASIC INFORMATION

1. ADMINISTRATIVE DETAILS
(a) Name of Institute under which Designated Ethics Committee is constituted:

(b) Name of the Ethics Committee:

(c) Name of Coordinating Principal Investigator:
(d) Designation and Qualification:
(e) Department/Division: (e) Date of Submission: Click here to enter a date.

(f) Address for communication (include email and mobile no.)

(f) Type of review requested1:

Exemption from Review Expedited Review Full Committee Review

(g) Title of the study:

Acronym/ Short title, (If any):

(h) Protocol number (If any): Version number: Date: Click here to enter a date.
(i) Number of studies where applicant is a:
i) Principal Investigator at time of submission: ii) Co-Investigator at time of submission:

(j) Duration of the study:

2. FUNDING DETAILS AND BUDGET

(a) Total estimated budget for study:
At site In India Globally
(b) Self-funding Institutional funding Funding agency
(Specify)
3. OVERVIEW OF RESEARCH

1Refer to National Ethical Guidelines for Biomedical & Health Research Involving Human Participants 2017on Page 36 Table 4.2. for the types
of review
 (a) Lay Summary of study2 (within 300 words)

(b) Type of study:

Basic Sciences Clinical Cross Sectional
Retrospective Epidemiological/ Public Case Control
Health
Prospective Socio-behavioural Cohort
Qualitative Systematic Review
Quantitative Biological
samples/Data
Mixed Method Any others (Specify)

4. METHODOLOGY
(a) Sample size/ No. of Participants (as applicable)
At site In India Globally
Control group Study Group
Justification for the sample size chosen (100 words); In case of qualitative study, mention the criteria
used for selection

(b) Is there an external laboratory/ outsourcing involved for investigations?3Yes No NA

(c) How was the scientific quality of the study assessed?
Independent external Review by Review within
review Sponsor/Funder PI’s institution
Review within multi- No Review
centre research group

Date of review: Click here to enter a date.

Comments of Scientific Committee, if any (100 words)

SECTION C - PARTICIPANT RELATED INFORMATION

5. RECRUITMENT AND RESEARCH PARTICIPANTS

2
Summarize in the simplest possible way such that a person with no prior knowledge of the subject can easily understand it.

3If
participant samples are sent outside for investigations, provide details of the same and attach relevant documentation such as an MTA/
MoU etc.
 (a) Type of participants in the study:
Healthy Patient Vulnerable person/ Others
volunteer Special groups (Specify)

Who will do the recruitment?

Participant recruitment methods used:
Posters/ TV/Radio Patients / Telephone
leaflets/Letters ads/social Family/Friends
media/Institution visiting
website hospitals
Others (Specify)

(b) i. Will there be vulnerable person/special groups involved? Yes No NA

ii. If yes, type of vulnerable person /special groups
Children under 18 yrs. Pregnant or lactating women

Differently abled (Mental/Physical) Employees/Students/Nurses/

Staff
Elderly Institutionalized

Economically and socially disadvantaged Refugees/Migrants/Homeless

Terminally Ill (stigmatized or rare
diseases)
Any other (Specify):

iii. Provide justification for inclusion/exclusion

iv. Are there any additional safeguards to protect research participants?

(c) Is there any reimbursement to the participant? Yes No

If yes, Monetary Non-monetary Provide details

(d) Are there any incentives to the participant? Yes No

If yes, Monetary Non-monetary Provide details

(e) Are there any participant recruitment fees/ incentives for the study provided to the PI/ Institution?

If yes, Monetary Non-monetary Provide details Yes No

6. BENEFITS AND RISKS

(a) i. Are there any anticipated physical/social/psychological discomforts/ risk to participants?
Yes No
 If yes, categorize the level of risk4:
Less than Minimal risk Minimal risk

Minor increase over minimal risk or More than Minimal Risk or High Risk
Low Risk
ii. Describe the risk management strategy:

(b) What are the potential benefits from the study? Yes No If yes, Direct Indirect
For the participant
For the society/community
For improvement in science
Please describe how the benefits justify the risks

(c) Are Adverse Events expected in the study5? Yes No NA

Are reporting procedures and management strategies described in the study? Yes No
If Yes, Specify

7. INFORMED CONSENT

(a) Are you seeking waiver of consent? If yes, please specify reasons and skip to question 8. Yes No

(b) Version number and date of Participant Information Sheet (PIS):

Version number and date of Informed Consent Form (ICF):
(c) Type of consent planned for:
Signed consent Verbal/ oral Witnessed Audio-Video
consent consent (A/V) consent
Consent from LAR For children<7 yrs Verbal assent Written Assent
(If so, specify from parental/LAR from minor (7- from Minor (13-
whom) consent 12 yrs) along 18 yrs) along with
with parental parental consent
consent
Other (specify)
(d) Who will obtain the informed consent?
PI/Co-I Nurse/Counselor Research Staff Other (Specify)

Any tools to be used

(e) Participant Information Sheet (PIS) and Informed Consent Form (ICF)
English Local language other (specify)
List the languages in which translations were done

If translation has not been done, please justify

(f) Provide details of Consent requirement for previously stored samples if used in the study6

4Forcategories of risk refer to National Ethical Guidelines for Biomedical & Health Research Involving Human Participants 2017. Page 6 in
Table 2.1

5The term adverse events in this regard encompass both serious and non-serious adverse events.
(g) Elements contained in the Participant Information Sheet (PIS) and Informed Consent Form (ICF)

Simple language Data/ Sample Compensation for study related injury

sharing
Risks and Need to recontact Statement that consent is voluntary
discomforts
Alternatives to Confidentiality Commercialization/benefit sharing
participation
Right to Storage of Statement that study involves research
withdraw samples
Benefits return of research Use of photographs/ identifying data
results
Purpose and Payment for Contact information of PI and Member
procedure participation Secretary of EC
Others(Specify)

8. PAYMENT/COMPENSATION
(a) Who will bear the costs related to participation and procedures7?
PI Institution Sponsor Other agencies(specify)

(b) Is there a provision for free treatment of research related injuries? Yes No NA

If yes, then who will provide the treatment?

(c) Is there a provision for compensation of research related SAE? If yes, specify. Yes No NA

Sponsor Institution/ Corpus funds Project grants Insurance

(d) Is there any provision for medical treatment or management till the relatedness is determined for
injury to the participants during the study period? If yes, specify. Yes No NA

(e) Is there a provision for ancillary care for unrelated illness during the study period? If yes, please
specify. Yes No NA

6Information on re-consent requiremnts can be found at National Ethical Guidelines for Biomedical & Health Research Involving Human
Particpants 2017, Page 54 in Section 5.8
7 Enclose undertaking from PI confirming the same

9. STORAGE AND CONFIDENTIALITY

(a) Identifying Information: Study Involves samples/data. If Yes, Specify Yes No NA

Anonymous/unidentified Anonymized: Irreversibly Identifiable

reversibly coded coded
If identifiers must be retained, what additional precautions will be taken to ensure that access is limited
/ data is safeguarded? (e.g. data stored in a cabinet, password protected computer etc.)
 (b) Who will be maintaining the data pertaining to the study?

(c) Where will the data be analyzed7 and by whom?

(d) For how long will the data be stored?

(e) Do you propose to use stored samples/data in future studies? Yes No Maybe
If yes, explain how you might use stored material/data in the future?

SECTION D: OTHER ISSUES

10. PUBLICATION, BENEFIT SHARING AND IPR ISSUES

(a) Will the results of the study be reported and disseminated? If yes, specify. Yes No NA

(b) Will you inform participants about the results of the study? Yes No NA

(c) Are there any arrangements for continued provision of the intervention for participants, if effective,
once the study has finished? If yes describe in brief (Max 50 words) Yes No NA

(d) Is there any plan for post research benefit sharing with participants? If yes, specify
Yes No NA

(e) Is there is any commercial value or a plan to patent/IPR issues. If yes, Please provide details
Yes No NA

(f) Do you have any additional information to add in support of the application, which is not included
elsewhere in the form? If yes, provide the details. Yes No

7For example, a data entry room, a protected computer etc.

SECTION E: CHECKLIST FOR COORDINATING PI

11. CHECKLIST
Enclosure EC
S.No Items Yes No NA No. Remarks
ADMINISTRATIVE REQUIREMENTS
1. Cover letter

2. Brief CV of all Investigators

3. Good Clinical Practice (GCP) training of investigators in

last 3 years
4. Approval of Scientific Committee/ NTF/ Central
Advisory Committee/ Any other
5. Agreement/MTA / LOA between collaborating
partners
6. Insurance policy/certificate

7. Evidence of external laboratory credentials in case of

an externally outsourced laboratory study QA/QC
certification
8. Copy of contract or agreement signed with the
sponsor or donor agency
PROPOSAL RELATED
9. Copy of the detailed protocol

10. Participant Information Sheet (PIS) and Informed

Consent Form (ICF)(English and translated)
11. Assent form for minors (12-18 years) (English and
Translated)
12. Proforma/Questionnaire / Case Report Forms (CRF)/
Interview guides/ Guides for Focused Group
Discussions (FGDs) (English and translated)
13. Advertisement/material to recruit participants (fliers,
posters etc)
PERMISSION FROM GOVERNING AUTHORITIES
Other Registration/ Required Not Received Applied EC Remarks
permissions required dd/mm/yy
14. CTRI8 Enter date

15. HMSC9 Enter date

16. Tribal Board Enter date

17. Any Other Enter date

ANY OTHER RELEVANT INFORMATION/DOCUMENTS RELATED TO THE STUDY

Item YES NO NA Enclosure EC remarks
no.
18.
8CTRI: Clinical Trial Registry- India, 9HMSC: Health Ministry’s Screening Committee

PART 2 (To be filled by S-PI at the Participating Centre)

General Instructions: a) Tick one or more as applicable. Mark NA if not applicable. Attach additional sheets if required
b) For submission to Participating Ethics Committee (PEC) and to be shared with coordinating PI
SECTION A - BASIC INFORMATION
1. ADMINISTRATIVE DETAILS
a) Name of the institute under which PEC is constituted:
b) Name of the Ethics Committee:
c) Name of Site Principal Investigator:
d) Designation/ Qualification: e) Department/ Division:
f) Address for communication (include mobile no. and email address):

g) Expected duration of the study: Estimated budget at the participating site:

SECTION B - RESEARCH INFORMATION

1. OVERVIEW OF RESEARCH
a) Briefly describe the role of the participating center in the study (50-100 words):

b) Briefly mention local changes made in protocol, if any:

c) Type of review requested:

Exemption from Review Expedited Review Full Committee Review

SECTION C – PARTICPANT RELATED INFORMATION

1. PATIENT RECRUITMENT AND RESEARCH PATIENTS
a) Number of participants to be recruited at site:
b) Site specific/ community concerns, if any

c) Briefly mention local changes in Recruitment/ Advocacy material:

d) Copy of the Local Recruitment/ Advocacy material: Yes No

2. INFORMED CONSENT
a) Who will obtain the informed consent?
S-PI/Co-S-PI Nurse/Counselor Research Staff Other (Specify)

Any tools to be used

b) Language/s ICD is translated in:

c) Version number and date of the Participant Informed Sheet (PIS) :
d) Version number and date of the Informed Consent form (ICF) :
e) Copy of the Local ICD translations enclosed: Yes No
f) Back translation of the ICD in English with the translation certificate Yes No

g) Changes made in informed consent form (ICF), if any:

 h) Copy of the audio / visual transcript for consent enclosed, if any: Yes No

3. DATA AND STORAGE

i) Brief details on data collection, storage, sharing, transfer, if any?

SECTION D – OTHER ISSUES

a) Do you have any additional information to add in support of the application, which is not included
elsewhere in the form? If yes, provide the details. Yes No

SECTION E – CHECKLIST FOR S-PI AT PARTICPATING CENTER

1. CHECKLIST
Sr.No Items Yes No NA EnclosureNo. EC Remarks
ADMINISTRATIVE REQUIREMENTS
1. Cover letter
Brief CV of Site Principal Investigator / other site
2.
Co-PI
Good Clinical Practice (GCP) training of
3.
investigator in last 3 years
4. Agreement between collaborating partners

5. MTA between collaborating partners

6. Insurance policy/certificate
PROPOSAL RELATED
7. Copy of the modified protocol
Participant Information Sheet (PIS) and Informed
8.
Consent Form (ICF) (English and translated)
Assent form for minors (12-18 years) (English and
9.
Translated)
Proforma/Questionnaire / Case Report Forms
10. (CRF)/ Interview guides/ Guides for Focused
Group Discussions (FGDs) (English and translated)
Advertisement/material to recruit participants
11.
(fliers, posters etc)
Any other relevant information/documents
12.
related to the study