Internal Quality Audit At Sites

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SOP :
Internal Quality Audit At Sites

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Internal Quality Audit At Sites

  1. 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 INTERNAL QUALITY AUDIT AT SITES SOP Number: Effective Date : Version Number & Date: Review Date: Superseded Version Number & Date : PURPOSE This SOP describes an overview of the procedure followed for internal quality audit at investigational sites.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. CONFIDENTIAL – STRICTLY FOR REFERENCE USE ONLY Page 1 of 3
  2. 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 INTERNAL QUALITY AUDIT AT SITES SOP Number: Effective Date : Version Number & Date: Review Date: Superseded Version Number & Date : Along with this, an audit agenda mentioning what information (documents) will be audited, who must be present, and when each portion of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 CONFIDENTIAL – STRICTLY FOR REFERENCE USE ONLY Page 2 of 3
  3. 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 CONFIDENTIAL – STRICTLY FOR REFERENCE USE ONLY Page 3 of 3

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