Checklist: Clinical Investigator Site Audit

This is a ready-to-use checklist for a GCP investigator site audit. Work it against a defined subject sample, mark each item Pass, Fail, or N/A, and record objective evidence for anything you fail. It is a working aid, not a substitute for professional judgment; follow the data wherever it leads. Replace every <<FILL: ...>> placeholder and align it to your protocol and SOPs. A partly filled sample and the common findings follow.

Audit identification

Field	Entry
Audit ID	`<<FILL>>`
Site number and name	`<<FILL>>`
Protocol	`<<FILL>>`
Auditor	`<<FILL>>`
Dates	`<<FILL>>`
Subject sample	`<<FILL: subject IDs and frame>>`
ICH E6 version applied	`<<FILL: R2 / R3>>`

How to score

Mark each item P (pass), F (fail), or N/A. For every F, record objective evidence (document, page, timestamp) and a preliminary classification (critical/major/minor). Do not mark P without seeing the evidence.

1. Regulatory and essential documents

#	Item	Reference
1.1	Signed, current protocol and all amendments on file	ICH E6 4.5; 8.2
1.2	IRB/EC approval current for protocol, ICF, and amendments	ICH E6 4.4; 21 CFR 56
1.3	Delegation log complete, signed, and matches who actually did the work	ICH E6 4.1.5
1.4	Investigator and staff CVs, licenses, and GCP training current	ICH E6 4.1
1.5	Lab certifications and current normal ranges on file	ICH E6 4.1; 8.2
1.6	Financial disclosure information collected	21 CFR 54

#	Item	Reference
2.1	Correct IRB/EC-approved ICF version used for each subject	ICH E6 4.8; 21 CFR 50
2.2	ICF signed and dated by subject before any trial procedure	ICH E6 4.8.8; 21 CFR 50.27
2.3	Consent process documented in source (who, when, opportunity to ask)	ICH E6 4.8.10
2.4	Re-consent performed on relevant amendments	ICH E6 4.8.2
2.5	For remote/eConsent, identity verification and version control evidenced	ICH E6 (R3 Annex 2 where applicable)

3. Eligibility

#	Item	Reference	P/F/NA	Evidence
3.1	Inclusion/exclusion criteria confirmed and documented before enrollment	ICH E6 4.5
3.2	Eligibility source data supports each enrollment	ICH E6 4.9

4. Source data and CRF

#	Item	Reference
4.1	Source-to-CRF verification on the sample: data match, no transcription errors	ICH E6 4.9
4.2	ALCOA+ attributes met (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available)	ICH E6 4.9; DI guidance
4.3	Corrections made properly (original legible, dated, initialed, reason where required)	ICH E6 4.9
4.4	eCRF audit trail intact and reviewable	21 CFR 11; ICH E6

5. Investigational product

#	Item	Reference
5.1	IP receipt, storage temperature records, and conditions within requirement	ICH E6 4.6
5.2	Accountability reconciles (received, dispensed, returned, destroyed)	ICH E6 4.6.3
5.3	Randomization followed; blinding maintained; unblinding controlled	ICH E6 4.7

6. Safety reporting

#	Item	Reference
6.1	AEs and SAEs captured in source	ICH E6 4.11
6.2	SAE reporting timelines to sponsor met	ICH E6 4.11.1; protocol
6.3	Causality and severity assessed; follow-up documented	ICH E6 4.11

7. Protocol compliance

#	Item	Reference
7.1	Visits within windows; procedures performed as required	ICH E6 4.5
7.2	Deviations recorded and reported per protocol/SOP	ICH E6 4.5.3
7.3	PI oversight of delegated staff evidenced	ICH E6 4.1; 4.2

8. Facilities and equipment

#	Item	Reference	P/F/NA	Evidence
8.1	Equipment calibration current; sample handling adequate	ICH E6 4.2
8.2	Restricted access to records, IP, and pharmacy	ICH E6 4.2; 4.6

Signoff

Role	Name	Signature	Date
Auditor	`<<FILL>>`
QA review	`<<FILL>>`

References

ICH E6 Good Clinical Practice (Section 4, investigator obligations; confirm R3 locations). 21 CFR Parts 312, 50, 54, 56. EU CTR 536/2014. MHRA and PIC/S data-integrity guidance for ALCOA+.

Confirm the current version of each reference and the ICH E6 version in force before use.

Filled sample (extract)

The following shows a partly completed extract for an illustrative audit. The subjects and evidence are illustrative.

#	Item	P/F/NA	Evidence
2.2	ICF signed before any trial procedure	F	Subject 014: screening draw 12-Mar, ICF signed 13-Mar (ICF p4, lab req). Preliminary: Critical
4.1	Source-to-CRF match on sample	P	12/12 sampled subjects match; no transcription errors
5.2	IP accountability reconciles	F	3 kits unaccounted across subjects 007, 019; no destruction record. Preliminary: Major
6.2	SAE reporting timelines met	F	SAEs for 007 and 019 reported day 6 and day 8 vs 24-hour requirement. Preliminary: Major

The extract shows the checklist doing its real job: it does not just tick boxes, it captures the specific evidence and a preliminary classification that flows straight into the audit report.

Common inspection findings this checklist targets

Informed consent obtained late, on the wrong version, or without re-consent after an amendment (the most common serious site finding).
Source data and records that miss the ALCOA+ attributes.
IP accountability that does not reconcile.
SAEs not reported to the sponsor or IRB/EC in the required timeframe.
Delegation log not matching who actually performed assessments.
Inadequate PI oversight of delegated staff.

How to adapt this checklist

Set the audit identification and the ICH E6 version applied.
Add protocol-specific items (special procedures, complex IP handling, decentralized elements) so the checklist matches this trial.
Where the trial has decentralized or real-world-data elements, add items for identity verification, distributed source data, and data provenance per ICH E6(R3) Annex 2.
Confirm every reference and the regulation set for the region before use.