GCP INSPECTION CHECKLIST

(This list is not all inclusive; item may be added &/or deleted as per the Study/Site/Sponsor/Lab)

I. General
1. Name and address of the
clinical trial site

2. Date of Inspection
Inspection Team Members:
3.

Personnel present during

4.
Inspection (with name and
role/designation.)

Address & Contact details of

5.
Investigator:

6. Name & address of the Sponsor

7. Name & address of clinical trial

NOC holder

8. Name & address of EC

9. Protocol Title

10. Protocol Number

Version/date
Protocol amendments, if any.

11. Investigational Product

 GCP INSPECTION CHECKLIST
Central Drugs Standard Control Organization

12. Stage of study: (A) Before Trial Commencement

(Mark the relevant) (B) During Conduct of the trial
(C) After Completion of Trial

13. Type of Inspection: Surveillance

For Cause

II.LEGAL & ADMINISTRATIVE ASPECTS:

S. no. Item Yes No NA Remark
1 Clinical trial NOC from O/o DCGI
(Note: mention along with Protocol no., Ver.,
date)

2 NOC for subsequent protocol amendments,

if any from O/o DCGI

3 Ethics Committee approval date

(Note: mention along with Protocol no., Ver.,
date)

3 Appendix VII as per Sch.-Y

(mention revision(s) and notification to O/o
DCGI, if any)

4 Whether valid financial agreement between

the Sponsor, Investigator & Institution
available.

5 Whether liability of involved parties

(Investigator, Sponsor and Institution)
clearly agreed.

6 Is the valid clinical trial Insurance available?

7 Site Initiation date

Date of screening of first subject,
8
Date of signing ICF by the first subject
9
Date of Last Patient-Last Follow-Up (if
10
applicable)

Whether SOP for various activities are

11
established and documented.

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Verify, whether the hospital/institute/site has

12
adequate emergency care facilities to handle
emergency situation.

III Organisation & Personnel

1 Assure that signed & dated, Curriculum
Vitae is available for the Investigator, Sub
Investigator /Co-Investigator

2 Confirm the educational qualification of the

Investigator with registration by Medical
Council of State/India.

3 Confirm the GCP, Schedule Y and protocol

specific training of Investigator, Sub-
Investigator/Co-Investigator and its team.

4 Determine whether authority for conducting

various clinical trial activities were delegated
properly by Investigator to competent
personnel (obtain the list of personnel and
duty delegation log).
5 Check whether the person whom the
authority is delegated is adequately qualified
and trained for the activity/activities
assigned.

6 Obtain the list of all clinical trials performed

by Investigator (Preferably for last three
years)
7 Ensure that the Investigator is involved in
conduct of not more than three clinical trials
at a time.

IV Conduct of Trial
A. Screening of subjects:
1 Check and review the informed consent for
the screening of the subjects.

2 Check site screening log & enrolment log

and obtain authenticated copy.

3 Check whether the subjects are meeting the inclusion/exclusion criteria as per the approved
protocol w.r.t review of source documents &/or CRF.
3.1 Clinical Examination by Investigator
( Check patient file/Source documents)

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3.2 Verify ,Clinical Laboratory Evaluation

( Check Blood Cell Counts, Biochemical
test, Urine analysis etc.as required by
protocol)

3.3 Verify X-Ray, MRI, ECG, USG or any other

technique required to ascertain the
inclusion/exclusion criteria.

3.4 Verify, Whether all conditions of Clinical

trial NOC are followed or not?

B. Subject record and Informed consent:

1 Whether ICF have all the elements enlisted
in Appendix V of Schedule Y.

Whether ICF is approved by Ethics

Committee prior to consent process.
Whether IC has been obtained from each
2
subject prior to participation of the subject in
the study.

Whether signature/thumb impression of the

3
subjects/legal representative have been
affixed with date.

4 Whether in case of illiterate subjects or

illiterate representative of a subject, there are
signature and details of an impartial witness.
Have witness/ signature being personally
5
dated.( If applicable).

6 Have patient/witness signature been

personally dated?
Has the dated signature of the designated
7
person for administering informed consent
(IC) been affixed?

Is the designated person for administering IC

8
medically qualified?

If IC has been administered by a designated

9
person who is not medically qualified, is
there evidence that subject's queries of a
medical nature were answered by a
medically qualified person or the
investigator?

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Is the completed ICF signed and dated by the

10
investigator?

Check weather re-consenting is done for

11
changes in ICF, if any.

B.1 Audio-Visual recording of Informed Consent Process( For ‘vulnerable population’ in ‘New
Chemical Entities (NCEs) clinical trial’ only & Anti HIV & Anti-Leprosy patients only Audio
recording) ( Verify as per GSR 611(E) dated 31.07.2015 )
Whether audio-visual recording is performed
1
for all subjects, independently.

Is audio-visual recording conducted in a

2
room conducive to recording of disturbance
free audio and video of the consent process?

Check whether the video recording is free

3
from disturbance to ensure that the image is
recognizable and the audio is clearly audible.

Check whether the recording of informed

4
consent process is preserved safely.

C. Source Documents and Case Record Form

Verify condition, completeness, legibility,
1
accessibility of the investigators source data
file. ( source data includes study subject’s
files, recording from automated instruments,
tracings, X-ray and other films, laboratory
notes, photograph negatives, magnetic
media, hospital records, clinical and office
charts, subject’s diaries, evaluation checklists
and pharmacy dispensing records)

Whether subject received the test drug with

2
respect to dose and frequency according to
the protocol;

Determine whether safety/ efficacy end point

3
data( Clinical, laboratory examination
results) were collected and reported in
accordance with the protocol

Does medical record mentions subject ID/

4
name /hospital registration number / and
indication that subjects are participating in a
clinical trial

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Compare the source document with CRF and

5
determine whether source data have been
correctly transcribed in CRF;

Verify the drop-outs and reason for drop-out

6
of subject is appropriately recorded.

Whether the withdrawal of subject from the

7
study is recorded and appropriately justified
in accordance with approved protocol.

Verify whether Standard Operating

8
Procedure of handling of Serious Adverse
Event occurred in clinical trial is available.

Verify whether all SAE’s have been reported

9
to the sponsor, EC and Licensing authority as
per the timelines in accordance with
Schedule Y.

(Verify as per GSR 53(E) dated 30.01.2013

& GSR 889 (E) dated 12.12.14 effective
from 12.06.2015 )

Verify Whether SOP for medical care during

10
serious adverse event is available or not.

Verify whether adequate medical care have

11
been given to the subject especially in the
event of inter current illness, adverse events
including abnormal lab parameters;

Verify whether all study related activities are

12
performed at site approved by O/o DCGI.

VI. Sponsor
Whether investigator maintain copies of all
1
report submitted to the sponsor;

Whether all CRF were submitted to sponsor

2
after completion of study;

Determine whether all dropout and reason

3
thereof were reported to sponsor;

Determine the method and frequency of

4
monitoring the progress of the study by the
sponsor and corrective action by site.

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Whether sponsor appointed a monitor with

5
appropriate qualification and experience to
monitor trial at the site.

Whether a log of onsite monitoring visit is

6
maintained at the site.

Is monitor submits visit report with

7
deviations if any to the sponsor.

Whether sponsor performed an audit as a part

8
of QA in order to independent and separate
from routine monitoring of quality control
function.

In case the investigator and sponsor agrees

9
to prematurely terminate or suspend the
study for any reason, whether it was
promptly informed to study subjects, Ethics
Committee and Licensing Authority.

VII. Investigational Product

Review individual subject record to verify
1
the correct dose administration with respect
to dose, frequency, route of administration

Determine whether unqualified /unauthorised

2
persons administered/dispensed the test drug

Determine whether adequate record of

3
quantity of test drug received , dispensed is
maintained.( Check the test drug
reconciliation and verify the leftover drug or
balance on the day of inspection).

Determine whether storage

4
condition/monitoring method are as per
protocol/recommendation;

Whether trial medication are maintained in

5
secured manner with controlled access;

Have un-used trial medications been returned

6
to the sponsor or disposed of according to
protocol?

Are the drugs dispensing records being

7
maintained properly?

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Whether the records for reconciliation of all

8
IP’s are maintained?

Are electronic or hand-written temperature

9
logs available for the storage area of the
investigational products?

Verify that investigation product is

10
appropriately labelled. (For clinical trial use
only).

VIII. Ethics Committee

Identify the name, address of the EC/ IEC in
1
the approval letter and compare it with one
stated in Investigator Undertaking.

Verify the Status of EC-whether Institutional

2
or Independent, Check Registration
certificate ( Verify as per GSR 72(E) dated
08.12.2013)

Verify if EC approval letter mention study

2
code , title and version number of the
protocol, list of other documents reviewed,
list of members present at the meeting,
quorum of five members as specified in
Schedule Y satisfied, date, time , venue of
the meeting, signature and date of member
secretary / Chairman.

Verify whether the EC recorded minutes of

3
meeting.

Verify whether EC is performed on site

4
monitoring of the clinical trial approved.

(Frequency and SOP)

Verify whether EC members have conflict of

5
interest in the approved trial, if yes then the
member should abstain from such approval
meeting.

Verify whether the communications between

6
Investigator and EC are available for
changes, Serious Adverse Event and
deviations occurred in clinical trial.

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Verify whether EC is function in accordance

7
with conditions of registration by LA.

IX Pathology Laboratory ( for Screening/ Assessment)

Name and address of the clinical laboratory
1
used in the study. (Local and Outside).
Whether financial & Confidentiality
2
agreement with Investigator and concerned
laboratory (ies) in place.
3 Is investigator/Sponsor verified the
accreditation status and adequacy of the
facilities to perform the specified tests as per
protocol.

4 Verify whether the SOP for sample

preparation, handling and transportation is
available. Verify the appropriateness of the
SOP.

X Quality Assurance
1 Verify whether SOP for all procedures
conducted at site are available
i.e. have a copy of Site Specific and Trial
specific SOPs

2 Verify the essential components of SOP like

who prepared, checked, authorized and
when, frequency of SOP revision
3 Whether SOPs for all operation like
screening and Informed consent Process, AV
recording of ICP of vulnerable population in
NCE-CTs, SAEs & its Management,
Communication with EC/Sponsor/CDSCO,
GCP/Sch.Y, training to trial team, training
assessment

4 Whether SOPs for all operation like IP

handling and distribution to study subjects,
blood samples collection, processing
preservation and transportation to local
laboratory.

5 Whether SOPs for all operation of storage

cabinets, refrigerators/deep freezers used to
store samples and IP are available.

6 Verify, whether records for job

description/responsibilities, qualification and
training for all personnel involved in the
clinical trial is maintained and stored.

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7 Verify whether the activities performed are

in compliance with duty delegated by
Investigator.

8 Verify whether concern staff is adequately

trained and records maintained there of

9 In case of vaccines, are a spillage SOP

available and the study team trained to
handle such an incidence?

XI Record keeping and data handling

1 Is adequate space available for document
retention?

2 Determine whether documents are

maintained properly and for the period as
specified.

3 Whether necessary measures have been taken

to prevent accidental or premature
destruction.

4 Whether the archival access controlled or

restricted to authorized personnel.

5 Weather SOP available to document all steps

in data management in order to allow step by
step retrospective assessment of data quality
and study performance.
6 Whether corrections in documents carry the
date and initials of Investigators and
authorized person.

XI-a Electronic data processing

1 Is electronic data processing is done by
authorized person?

2 Verify whether list of authorized persons to

make changes is maintained

3 Verify if provision for recording of trail of

changes and deletions made is available.

4 Whether the hardware and software use for

data recording and processing is validated

Collect authenticated copies as exhibit wherever any Critical &/or Major non-compliance has been observed.

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