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

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Clinical Event Committees • Include CEC members who are • Independent from the study • Knowledgeable in the therapeutic area being studied • Experienced in the conduct of clinical research • Train CEC members to • Study protocol, study definitions, CEC procedures, case report forms, adjudication forms
• CRF Design Core Labs • Design of CRF (and analysis) tailored to protocol and knowledge of software capabilities for valid reproducible analysis • CRF programming requires validation and built in cross checks • Data entry requires 100% QC: double data entry is optimal, if single data entry then second pass visual validation should be employed • Site training • Provide detailed, but easy to use instructions to the sites to acquire medium in a standard manner to ensure data quality
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: Clinical Event Committees • Devel
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 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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