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

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Independence of DSMB (2) • Sponsor interaction with DSMB • “Open” part of meeting to review enrollment, compliance, event rates in aggregate as well as sponsor goals, plans, and resources • DSMB can address questions from interim comparative data review to sponsor
Independence of DSMB (3) • Independence of statistician • Primary trial statistician has most knowledge about trial but doing interim analysis and participating in DSMB would compromise objectivity of DSMB as well as statistician’s objectivity with ongoing study management • Recommendation is to employ a contractor statistician
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 and 8: Blinding • Safety monitoring •
Page 9 and 10: Clinical Event Committees • Devel
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: Independence of DSMB • Independen
Page 30: Thank You

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

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