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

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Determining Need for DSMB (3) • Will DSMB help assure scientific validity of the trial? • Changes over time in understanding of disease, affected population and standard of care during long duration can lead to modifications to trial – best if recommended by unbiased group • Accumulating event rates may suggest need for modifications
DSMB Relation to Other Groups • IRBs / Ethics Committees • Clinical Trial Steering Committee • Endpoint Adjudication Committee or Clinical Events Committee (CEC) • Site / Clinical Monitoring • Investigators • Sponsor
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: Determining Need for DSMB (2) • 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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