SOP : Internal Quality Audit At Sites

1. INTERNAL QUALITY AUDIT AT SITES
SOP Number: Effective Date :
Version Number & Date:
Review Date:
Superseded Version Number & Date :
PURPOSE
This SOP describes an overview of the procedure followed for
internal quality audit at investigational sites.
RESPONSIBILITY
This SOP is applicable to Internal Quality Assurance Auditors of
XXXXX conducting internal audits at investigational sites.
PROCEDURE
1. The XXXXXX Quality Assurance designate will conduct internal
audits at all sites where clinical trials are going on. Internal
quality audit shall be conducted at intervals as deemed,
depending on the duration of study.
2. XXXXXX Quality Assurance designate shall plan the conduct of an
audit well in advance (XX days) and inform the Site team by
sending an official audit notification letter (Appendix A) for
mutual confirmation of a convenient date.
3. An internal file audit at XXXXXX shall be done every quarterly
before & also before site audit and any discrepancy noted shall
be resolved in conjunction with the site team well before the site
audit. (See Appendix B for File audit checklist)
4. The Quality Assurance designate shall prepare an audit
checklist, which details the list of activities that will be performed
at the site.
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2. INTERNAL QUALITY AUDIT AT SITES
SOP Number: Effective Date :
Version Number & Date:
Review Date:
Superseded Version Number & Date :
Along with this, an audit agenda mentioning what information
(documents) will be audited, who must be present, and when
each portion of the audit will occur shall be sent to the site team
at least X weeks/days in advance (See Appendix C for Site Audit
checklist).
5. The auditor must confirm that all necessary site personnel and
the documentation that will be reviewed will be available during
the audit.
6. On the day of audit the auditor will present his/her identification
to the site team and brief information on how the audit process
will be conducted. This will include rationale and scope of the
audit, expected duration of audit, administrative procedures, how
findings will be reported, and discussion with site team involved
in the study.
7. All components of audit findings will be categorized as
• Category 1, 2, 3 and 4
(See Appendix D for details of Categories)
8. On completion of the audit the auditor will have an exit
discussion with the site team on audit findings and
recommendations, and immediate feedback and clarifications.
9. Findings under category 4 will be sent to PI and the CRC for
necessary actions.
10. CAPA will be sent to the CRC and will be followed up until all
queries are resolved.
11. After resolution of all findings/queries, the auditor will
complete the final audit report, which will contain details of audit
findings and the answers, provided by the CRC & site team. The
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3. INTERNAL QUALITY AUDIT AT SITES
SOP Number: Effective Date :
Version Number & Date:
Review Date:
Superseded Version Number & Date :
final audit report will be sent to the MD, after the answers from
the PI are received.
The Audit Report
The observations discussed during the wrap-up meeting will be
documented in the report so that effective corrective actions should
be taken. The audit report will be prepared under following sections.
• Scope.
• Introduction
• Executive Summary
• Major Findings
• Regulatory Documents
• Clinical Data Review
• Conclusion
CONTACTS
1. Quality Assurance Designate
2. Regional Head of Quality Assurance
3. Director of Quality Assurance
LINKS
None
APPENDIX
Appendix A: Audit notification letter
Appendix B: File audit checklist
Appendix C: Site Audit checklist
Appendix D: Categories- components of audit findings
FOR FURTHER DETAILS CONTACT:
clinswift@gmail.com
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