Audit of a Clinical Trial Site

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What is Audit ?

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ICH GCP 1.6 Audit

A systematic and independent examination trial-related activities and documents

of

determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, 3/10/12 sponsors standard operating

to

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Type of audits

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Routine
To

assure compliance with

sponsor, federal and local regulations

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For cause
Auditing

group has evidence or suspects non-compliance with some aspect of the clinical trial requirements

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Who conducts audits ?

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Who conducts audits ?

Sponsor

regulatory department representatives regulatory

International

authorities
US FDA EU Authorities (UK, France)
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When audits occur ?

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When audits occur ?

During After

the trial

the trial has been completed

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Why ?

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Regulatory requirement
ICH

GCP 5.19 GCP 3.1.14

Indian

Sponsor

should perform audit as a part of QA system

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Sponsor audit

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Sponsor Audit Visit

Typically

conducted by sponsor regulatory department independent examination of trial-related activities and documents

An

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Sponsor Audit Visit Objectives and Goals

Assure

subject rights and welfare are being adequately protected investigator site compliance to protocol regulatory compliance sponsor monitoring

Assess

Assure
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Assess

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HOW ?

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1. 2. 3. 4. 5. 6. 7.

Auditor Auditee Audit plan Sampling Checklist Audit report CAPA Follow-up

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Audit Visit Activities

Inspect Review Discuss

facility qualifications of staff

trial roles and responsibilities of staff trial document file

Review
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Preparation of audit

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Face the audit

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DONT

PANIC! Most likely, your site has been chosen for inspection because the data are felt to have been an important contribution to the trial conclusion

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Responding to an Auditor
Request Identify

to see identification

which trial the auditor wants to inspect the CRFs and trial document file for that specific trial

Retrieve

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Common Audit Findings

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Protocol

noncompliance source documents

Inadequate Inadequate

investigational product(s) records consent issues

Informed
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Common Audit Findings: Protocol Noncompliance

Serious

adverse event or deaths not reported in timely manner or exclusion criteria

Inclusion

violated
Prohibited

concomitant medications taken

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Common Audit Findings: Inadequate Source Documents

Documents

for all subjects not

available
Records

on screen failures not maintained between CRF and source documents

Discrepancies

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Common Audit Findings: Inadequate Investigational Product(s) Records

No

records of investigational product(s) receipt and return product(s) log and dosing in CRF inconsistent documentation of the investigational product(s) that subjects forgot to return

Investigational

Unclear

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Common Audit Findings: Informed Consent Issues

Subject

did not sign informed consent form prior to protocol procedures being performed failed to sign informed consent form amendments consent form not properly dated

Subject

Informed
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