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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

of trial-related activities anddocuments 

to determine whether the evaluated

trial related activities wereconducted, and the data wererecorded, analyzed and accurately 

reported according to the protocol,s onsor’s standard o eratin

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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 orsuspects non-compliance with

some aspect of the clinical trialrequirements

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Who conducts audits ?

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Who conducts audits ?

Sponsor regulatory departmentrepresentatives

International regulatoryauthorities

US FDA

EU Authorities (UK, France)

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When audits occur ?

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When audits occur ?

During the trial

After the trial has beencompleted

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Why ?

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Regulatory requirement

ICH GCP 5.19

Indian GCP 3.1.14

Sponsor should perform audit as apart of QA system

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Sponsor audit

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Sponsor Audit Visit

Typically conducted by sponsorregulatory department

An independent examination of trial-related activities anddocuments

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Sponsor Audit VisitObjectives and Goals

Assure subject rights andwelfare are being adequatelyprotected

Assess investigator sitecompliance to protocol

Assure regulatory compliance

Assess sponsor monitoring

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1. Auditor

2. Auditee

3. Audit plan

4. Sampling

5. Checklist6. Audit report

7. CAPA

8. Follow-up

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Audit Visit Activities

Inspect facility

Review qualifications of staff 

Discuss trial roles and

responsibilities of staff 

Review trial document file

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Preparation of audit 

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Face the audit

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DON’T PANIC!Most likely, your site has beenchosen for inspection becausethe data are felt to have been animportant contribution to thetrial conclusion

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Responding to anAuditor

Request to see identification

Identify which trial the auditorwants to inspect

Retrieve the CRF’s and trialdocument file for that specifictrial

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Common Audit Findings

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Protocol noncompliance

Inadequate source documents

Inadequate investigational

product(s) records

Informed consent issues

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Common Audit Findings:Protocol Noncompliance

Serious adverse event or deathsnot reported in timely manner

Inclusion or exclusion criteriaviolated

Prohibited concomitantmedications taken

o o u s:

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o o u s:Inadequate Source

DocumentsDocuments for all subjects notavailable

Records on screen failures notmaintained

Discrepancies between CRF andsource documents

ommon u t F n ngs:

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ommon u t F n ngs:Inadequate InvestigationalProduct(s) Records

No records of investigationalproduct(s) receipt and return

Investigational product(s) logand dosing in CRF inconsistent

Unclear documentation of theinvestigational product(s) thatsubjects forgot to return

C di i di

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Common Audit Findings:Informed Consent Issues

Subject did not sign informedconsent form prior to protocolprocedures being performed

Subject failed to sign informedconsent form amendments

Informed consent form notproperly dated

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