Audit of a Clinical Trial Site
-
Upload
pavanbagga -
Category
Documents
-
view
217 -
download
0
Transcript of Audit of a Clinical Trial Site
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 1/30
3/10/12
Audit of a Clinical Trial
Site
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 2/30
Click to edit Master subtitle style
3/10/12
What is Audit ?
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 3/30
3/10/12
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
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 4/30
Click to edit Master subtitle style
3/10/12
Type of audits
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 5/30
3/10/12
Routine
To assure compliance with
sponsor,
federal and local regulations
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 6/30
3/10/12
“For cause”
Auditing group has evidence orsuspects non-compliance with
some aspect of the clinical trialrequirements
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 7/30
Click to edit Master subtitle style
3/10/12
Who conducts audits ?
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 8/303/10/12
Who conducts audits ?
Sponsor regulatory departmentrepresentatives
International regulatoryauthorities
US FDA
EU Authorities (UK, France)
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 9/30
Click to edit Master subtitle style
3/10/12
When audits occur ?
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 10/303/10/12
When audits occur ?
During the trial
After the trial has beencompleted
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 11/30
Click to edit Master subtitle style
3/10/12
Why ?
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 12/303/10/12
Regulatory requirement
ICH GCP 5.19
Indian GCP 3.1.14
Sponsor should perform audit as apart of QA system
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 13/30
Click to edit Master subtitle style
3/10/12
Sponsor audit
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 14/303/10/12
Sponsor Audit Visit
Typically conducted by sponsorregulatory department
An independent examination of trial-related activities anddocuments
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 15/303/10/12
Sponsor Audit VisitObjectives and Goals
Assure subject rights andwelfare are being adequatelyprotected
Assess investigator sitecompliance to protocol
Assure regulatory compliance
Assess sponsor monitoring
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 16/30
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 17/30
3/10/12
1. Auditor
2. Auditee
3. Audit plan
4. Sampling
5. Checklist6. Audit report
7. CAPA
8. Follow-up
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 18/30
3/10/12
Audit Visit Activities
Inspect facility
Review qualifications of staff
Discuss trial roles and
responsibilities of staff
Review trial document file
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 19/30
3/10/12
Preparation of audit
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 20/30
3/10/12
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 21/30
3/10/12
Face the audit
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 22/30
3/10/12
DON’T PANIC!Most likely, your site has beenchosen for inspection becausethe data are felt to have been animportant contribution to thetrial conclusion
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 23/30
3/10/12
Responding to anAuditor
Request to see identification
Identify which trial the auditorwants to inspect
Retrieve the CRF’s and trialdocument file for that specifictrial
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 24/30
Click to edit Master subtitle style
3/10/12
Common Audit Findings
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 25/30
3/10/12
Protocol noncompliance
Inadequate source documents
Inadequate investigational
product(s) records
Informed consent issues
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 26/30
3/10/12
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:
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 27/30
3/10/12
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:
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 28/30
3/10/12
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
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 29/30
3/10/12
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
8/2/2019 Audit of a Clinical Trial Site
http://slidepdf.com/reader/full/audit-of-a-clinical-trial-site 30/30
3/10/12