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

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History of DSMB • First used for large randomized multicenter trials in 1960s that were federally funded in the U.S. • Recognition that interim monitoring of accumulating study data was essential to ensure the ongoing safety of participants • Involvement of expert advisors external to trial would address problems in an unbiased way
Functions of DSMB • Reviews the accumulating data from clinical trial on an ongoing basis • Advises sponsor regarding continuing safety of trial subjects • Advises sponsor regarding continuing validity and scientific merit of the trial
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: Data Standards • Determine Access
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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