Page 301 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Internal Audits Research Administration SOP No: R106 SOP Title: Internal Audits
5.3.3.3 Study Data: Verify data is accurate legible, verifiable and consistent across the subject’s binder, subject’s medical records, results, EDC entry, and documentation.
The auditor will generate report upon completion of the audit and notify members of the team if further action items need to be addressed.
5.4 Addressing Audit Observations
Upon completing the internal audit report with the team, evaluate the observations and devise a plan for addressing the items and documenting the corrective actions.
5.4.1 Delegate the items for corrective action to the appropriate study team member.
5.4.2 Discuss how each item should be corrected.
5.4.3 Discuss a time course for resolving each item.
5.4.4 Discuss how and when a follow-up review will take place in order to track the progress of closing the report.
5.4.5 For all reportable events, a designated team member should follow the regulations, protocol, or procedures for accurately reporting to the appropriate entities. Documentation of all correspondence, and participation of reporting the reportable events should be documented and kept in the regulatory and subject binders as appropriate.
5.4.6 Documentation should be made of the resolution and corrective actions to all audit observations according to the plan proposed by the study team. This documentation should be filed in the regulatory binder.
6. RELATED DOCUMENTS
Chart Audit Tool Maintenance Checklist Study Close-Out Checklist Note to file Template ALCOA Documentation UPIRSOs Tracking
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