Essential Documents for Conduct of Clinical Trial: Checklist

Documents Before the Clinical Phase of the Trial Commences:

Title of the document Purpose Located in files of:

Inv Spons CRO IEC

Investigator’s brochure To document that relevant and current

1 scientific information about the · · · ·
investigational product has been provided
to the investigator
Signed protocol To document investigator and sponsor
2 And amendments, if any, agreement to the protocol/amendment(s) · · · ·
and sample and CRF
case report form(CRF)

Information given to trial To document the informed consent

3 subject · · · ·
- informed consent form
(including all applicable
translations)
- Any other To document that subjects will be given
4 written information appropriate information (content and · · · ·
wording) to support their ability to give
fully informed consent

- Advertisement To document that recruitment measures

5 for subject recruitment are appropriate and not coercive · · · ·
(if used)

Financial aspects of the To document the financial agreement

6 trial between the investigator/institution and · · · ·
the sponsor for the trial

Insurance statement To document that compensation to

7 (where required) subject(s) for trial-related injury will be · · · ·
available

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 Title of the document Purpose Located in files of:
Inv Spons CRO IEC

8 Dated, documented To document that the trial has been · · · ·

approval / favourable subject to IEC review and given approval /
opinion of independent favourable opinion.
ethics committee (IEC) of To identify the version number and date
the following: of the document(s)

- protocol and any

amendments

- CRF (if applicable)

- informed consent
form(s)

- any other
written information to be
provided to the subject(s)

- advertisement
for subject recruitment

9 Independent ethics To document that the IEC · · · ·

committee composition is constituted in agreement with GCP

10 Regulatory authority(ies) To document appropriate authorisation / · · · ·

authorisation / approval / approval / notification by the regulatory
notification of protocol authority(ies) has been obtained prior to
(where required) initiation of the trial in compliance with
11 Curriculum vitae and/or the applicablequalifications
To document regulatory requirement(s)
and eligibility · · · ·
other relevant to conduct trial and/or provide medical
documents evidencing supervision of subjects
qualifications of
Investigator(s) and Co-
Investigator / Sub-
Investigator(s)

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 Title of the document Purpose Located in files of:
Inv Spons CRO IEC

12 Normal value(s) / To document normal values and/or · · · N/A

range(s) for medical / ranges of the tests
laboratory / technical
procedure(s) and/or
test(s) included in the
protocol

13 Sample of label(s) To document compliance with applicable · · · N/A

attached to labelling regulations and appropriateness
investigational product of instructions provided to the subjects
container(s)

14 Instructions for handling To document instructions needed to · · · N/A

of investigational ensure proper storage, packaging,
product(s) and trial- dispensing and disposition of
related materials investigational products and trial-related
(if not included in materials
protocol or Investigator’s
Brochure)

15 Shipping records for To document shipment dates, batch · · · N/A

investigational product(s) numbers and method of shipment of
and trial-related investigational product(s) and trial-related
materials materials. Allows tracking of product
batch, review of shipping conditions, and
accountability
16 Certificate(s) of analysis To document identity, purity, and N/A · · N/A
of investigational strength of investigational product(s) to
product(s) shipped be used in the trial
Decoding procedures for To document how, in case of an · · · N/A
blinded trials emergency, identity of blinded
investigational product can be revealed
17 without
Master randomization listTo breaking
document the blind
method for the
for randomization N/A · · N/A
of trial population
18 Pre-trial monitoring To document that the site is suitable for N/A · · N/A
report trial (may be combined with Trial
initiation monitoring report)

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Global Health Network. Please reference The Global Health Network when
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 Title of the document Purpose Located in files of:
Inv Spons CRO IEC

19 Trial initiation monitoring To document that the trial procedures · · · N/A

report were reviewed with the investigator and
the investigator’s trial staff

(may be combined with Pre-trial

monitoring report)

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Global Health Network. Please reference The Global Health Network when
you use it, and share your own materials in exchange.
www.theglobalhealthnetwork.org.
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 During the Clinical Conduct of the Trial

In addition to having on file the above documents, the following should be added to the files
during the trial as evidence that all new relevant information is documented as it becomes
available.

Title of the document Purpose Retained in the file of:

Inv Spons CRO IEC
20 Investigator’s brochure To document that investigator is · · · ·
updates informed in a timely manner of
relevant information as it
becomes available
21 Any revision to: To document revisions of these · · · ·
- protocol amendment(s) trial related documents that take
and CRF effect during trial
- informed consent form
- any other written
information provided to
subjects
- advertisement for
subject recruitment(if
used)

22 Dated, documented To document that the trial has

approval / favourable been subject to IEC review and
opinion of IEC of the given approval / favourable
following: opinion.
- protocol amendment(s) To identify the version number
- revision(s) of: and date of the document(s).
- informed consent form
- any other written
Information provided to
subject
- advertisement for
Subject recruitment(if
used)
- any other documents
given approval /
favourable opinion
- continuing review of
trial (where required)
Regulatory authority(ies) To document compliance with · · · ·
23 authorisations / applicable regulatory
approvals / notifications requirements
where required for:
- protocol amendment(s)
and other documents

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Global Health Network. Please reference The Global Health Network when
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 Title of the document Purpose Retained in the file of:
Inv Spons CRO IEC
Curriculum vitae for new To document qualifications and
24 investigator(s) and / or eligibility to conduct trial and/or · · · ·
sub- investigator(s) provide medical supervision of
subjects

Updates to normal To document normal values and N/A

25 value(s) / range(s) for ranges that are revised during the · · ·
medical / laboratory / trial
technical procedure(s) /
test(s) included in the
protocol
Medical / laboratory / To document that tests remain N/A
26 technical procedures / adequate throughout the trial · · ·
tests period
- certification or
- accreditation or
- established quality
control and / or external
quality assessment or
- other validation (where
required)

Documentation of To document shipment dates, N/A

27 investigational product(s) batch numbers and method of · · ·
and trial-related material shipment of investigational
shipment product(s) and trial-related
materials. Allows tracking of
product batch, review of shipping
conditions, and accountability
Certificate(s) of analysis To document identity, purity, and N/A N/A
28 for new batches of strength of investigational · ·
investigational products product(s) to be used in the trial

Monitoring visit reports To document site visits by, and N/A N/A
29 findings of, the monitor · ·

Relevant To document any agreements or N/A N/A

30 communications other significant discussions regarding · ·
than site visits trial administration, protocol
- letters violations, trial conduct, adverse
- meeting notes event (AE) reporting
- notes of telephone calls
31 Signed informed consent To document that consent is (Original) (Copy) (Copy)

forms obtained in accordance with GCP N/A

and protocol and dated prior to
participation of each subject in

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Global Health Network. Please reference The Global Health Network when
you use it, and share your own materials in exchange.
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 Title of the document
Source documents
32
Signed, dated and
33 completed case report
forms (CRF)
Documentation of CRF
34 corrections
Notification by
35 originating investigator to
sponsor of serious
adverse events and
related reports
Notification by sponsor
36 and/or investigator,
where applicable, to
regulatory authority(ies)
and IEC(s) of unexpected
serious aderse drug
reactions and of other
safety information
37 Notification by sponsor
to investigators of safety
information
Interim or annual reports
38 to IEC and authority(ies)
Subject screening log
39
Subject identification
40 code list
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Purpose Retained in the file of:
Inv Spons CRO IEC
trial. Also to document direct
access permission
To document the existence of the (Original) (Copy) (Copy)
subject and substantiate integrity N/A
of trial data collected. To include
original documents related to the
trials, to medical treatment, and
history of subject
To document the existence of the (Copy) (Copy) Copy) N/A
subject and substantiate integrity
of trial data collected. To include
original documents related to the
trial, to medical treatment, and
history of subject
To document all changes / (Original) (Copy) (Copy) N/A
additions or corrections made to
CRFafter initial data were
recorded
Notification by originating
investigator to sponsor of serious · · · ·
adverse events and related
reports
Notification by sponsor and/or
investigator, where applicable, to · · · ·
regulatory authorities and IEC(s) of
unexpected serious adverse drug
reactions and of other safety
information
Notification by sponsor to
investigators of safety information · · · ·
Interim or annual reports provided
to IEC and to authority(ies) · · · ·
To document identification of · (Where (Where N/A
required required)
subjects who entered pre-trial )
screening
To document that investigator / N/A
Institution keeps a confidential list · · ·
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Global Health Network. Please reference The Global Health Network when
you use it, and share your own materials in exchange.
www.theglobalhealthnetwork.org.
 Title of the document Purpose Retained in the file of:
Inv Spons CRO IEC
of names of all subjects allocated
to trial numbers on enrolling in
the trial. Allows investigator/
Institution to reveal identity of any
subject

Subject enrolment log To document chronological N/A

41 enrolment of subjects by trial · · ·
number

Investigational products To document that investigational N/A

42 accountability at the site product(s) have been used · · ·
according to the protocol

To document signatures and N/A

43 Signature sheet initials of all persons authorised to · · ·
make entries and / or corrections
on CRFs
N/A
44 Record of retained body To document location and · · ·
fluids/ tissue samples identification of retained samples
(if any) if assays need to be repeated

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Global Health Network. Please reference The Global Health Network when
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 After Completion or Termination of the Trial

After completion or termination of the trial, all of the documents identified should be in the file
together with the following

Title of the document Purpose Retained in the files of:

Inv Spo CRO IEC
ns
N/A
45 Investigational product(s) To document that the investigational · · ·
accountability at site product(s) have been used according to
the protocol. To documents the final
accounting of

investigational product(s) received at the

site, dispensed to subjects, return by the
subjects, and returned to sponsors
Documentation of To document destruction of unused N/A
(if
46 investigational product investigational products by sponsor or at destro · ·
destruction site yed at
site)

Completed subject To permit identification of all subjects N/A

47 identification code list enrolled in the trial in case follow-up is · · ·
required. List should be kept in a
confidential manner and for agreed upon
time
Audit certificate (if To document that audit was performed N/A N/A
48 available) · ·

Final trial close-out To document that all activities required for N/A N/A
49 monitoring report trial close-out are completed, and copies · ·
of essential documents are held in the
appropriate files
Treatment allocation and Returned to sponsor to document any N/A N/A
50 decoding documentation decoding that may have occurred · ·

Final report by To document completion of the trial

51 investigator to IEC where · · · ·
required, and where
applicable, to the
regulatory authority(ies)
Clinical study report To document results and interpretation of
52 trial · · · ·

This template has been freely provided by Dr Sreedhar Tirunagari via The
Global Health Network. Please reference The Global Health Network when
you use it, and share your own materials in exchange.
www.theglobalhealthnetwork.org.
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