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

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DSMB Composition • Clinicians with expertise in relevant clinical specialty • Statistician familiar with statistical methods for clinical trials and sequential analysis of data • Others might include epidemiologist, ethicist, pharmacologist • No conflicts of interest (financial, intellectual, influence on trial)
DSMB Charter • Procedural issues • Meeting schedule, format, structure, quorum, minutes • Report formats and codes • Statistical methods • Group sequential methods with interim analyses defined by time intervals or amount of information • Stopping rules
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: DSMB Relation to Other Groups • I
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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