Ich Gcp Essential Document Checklist
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1
2ICH GCP Essential Document Checklist
Study Number: _______________________________ Status:
Pre-Activation;
Active Study;
Closing
Study Type:
Clinical Drug Trial;
Non-Drug Subject Research
(ICF);
Non-Drug Research (No ICF)
Usual Regulatory Binder Items:
Location of Document (if/when applicable) date:
Regulation Section
Document
Not
Regulatory
Coordinator
Other
Number
Applicable
Binder
Manual
Location
8.3.20
Subject Screening log
5.5.5,
8.3.21
&
8.4.3
Subject ID code list
8.3.22
Subject enrollment Log
8.3.12
Signed ICFs
8.2.2
&
8.3.2
(Signed) Protocol & Amendments
5.5.2
Data Safety Monitoring Plan (if applicable)
8.2.7,
8.2.9
&
8.3.4
IRB approval
8.2.8
IRB Membership Roster
8.2.3
&
8.3.2
&
8.3.3
Ongoing approved ICF & subject materials
8.2.9
&
8.3.4
^IND (1571, 3674, FDA correspondence)
Clinicaltrials.gov
8.3.19
Interim/annual IRB reports
8.4.4
Audit certificate (if performed)
^Sponsor only
^Sponsor only
8.4.5
Final close-out monitor & DSMB reports
8.4.7
IRB/FDA closure report(s)
8.3.17
PI to IRB/FDA: SAE reports
^Sponsor only
8.2.19
Pre-Trial Monitor report
8.2.20
Trial Initiation (SIV) Monitoring Report
^Sponsor only
8.3.10
Monitoring visit reports
8.3.11
Relevant correspondence
8.4.8
Clinical study report (if applicable)
8.2.11
&
8.3.6
Lab normal reference ranges (& updates)
8.2.12
&
8.3.7
Lab Certificate, CV, ML (& updates)
8.2.1
&
8.3.1
Investigator Brochure & Updates
8.3.18
Sponsor to Site: safety & DSMB reports
8.2.10
&
8.3.5
CV, ML, FDF of PI & sub-Is
4.1.5
Delegation Log or List
8.3.24
signatures/initials for CRF entry/corrections
4.2.4
Training (Documentation)
21CFR312.53c
Completed FDA form 1572
Place NTF in binder noting ‘other location’ as necessary.
______________________________________________________________
_____________________
Regulatory contact signature
Initial review date
Pre-activation
requirements,
Active study
requirements, Study closure requirements,
Other required
documents.
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Parent category: Life