Page 203 - eBook Version 8 Book 1 of 2 JUL 2022

Internal Quality reviews Research Administration SOP No: R-Reg-104 SOP Title: Internal Quality Reviews
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 quality review observations according to the plan proposed by the study team. This documentation should be filed in the regulatory binder.
RELATED DOCUMENTS
Chart Quality review Tool
Maintenance Checklist (Essential Quality Review) Study Close-Out Checklist
Note to file Template
ALCOA Documentation
UPIRSOs Tracking
7. PROCEDURE PROCESS MAP
At the Appropriate Intervals / Upon Inheritance of an Existing Study
D057
Discuss Audit Obtain Direct Confirm Study Intervals with
Accesses Approvals Study Team for Study Needs
Conduct Audit Using Interval Tool
Draft a Report and Discuss with Study Team
Corrective Action
Follow Up / Review Documents
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Study Coordinator
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