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

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DSMB Responsibilities • Interim monitoring • Monitoring for effectiveness • Monitoring for safety • Monitoring study conduct • Consideration of external data • Making recommendations • Maintaining meeting records
Independence of DSMB • Independence from sponsor • DSMB remains objective • Increases credibility of trial’s conclusions • Sponsor maintains ability to make trial modifications in response to external data without introducing bias
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: DSMB Charter • Procedural issues
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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