Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com

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Clinical Event Committees • Develop standardized processes for source document collection • Request and receipt logs • Review for completeness and compile into written dossier prior to CEC meeting • Follow-up for ongoing events • Develop CEC Charter for each trial • Determine well-defined and consistent terms in the protocol / investigational plan so these definitions can be used for consistency during the adjudication • Determine which events are to be adjudicated
Clinical Event Committees • Develop standardized CEC processes • Meeting schedule and required attendees • Signature form for each meeting • Adjudication process • Meeting minutes • Tracking process for event adjudication status • Develop a reconciliation process • For events discovered by the CEC during adjudication that meet study endpoints but were not coded or reported as such by site staff • Reconciliation of the clinical database site reported events against CEC adjudicated events and all database entries (multiple Core Lab database entries- QCA, IVUS, ECG, etc.) and CEC adjudicated outcomes
Page 1 and 2: Quality Control in Clinical Trials
Page 3 and 4: Documentation • Most important to
Page 5 and 6: • During the study Blinding • U
Page 7: Blinding • Safety monitoring •
Page 11 and 12: • CRF Design Core Labs • Design
Page 13 and 14: Data Standards • Design effective
Page 15 and 16: Data Standards • Determine Access
Page 17 and 18: Functions of DSMB • Reviews the a
Page 19 and 20: Determining Need for DSMB (2) • I
Page 21 and 22: DSMB Relation to Other Groups • I
Page 23 and 24: DSMB Charter • Procedural issues
Page 25 and 26: Independence of DSMB • Independen
Page 27 and 28: Independence of DSMB (3) • Indepe
Page 30: Thank You

Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com

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