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

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Core Labs • Core Lab analysis • Trained personnel with current training records, daily feedback, weekly training sessions, and annual training updates • Establish a standard process for the Core lab cycle: receiving, labeling, analyzing, reviewing, managing data, and communicating with data management group and sponsor • QC of analysis varies: US standard is 100% review of technical aspects of analysis • Validation with measurement accuracy and precision of quantitative measures and qualitative measures • Process, validations, analysis must be detailed in SOPs that are well maintained and current
Data Standards • Design effective CRFs • Design with the final analysis in mind • Well designed CRFs limit data issues and increase data entry efficiency and compliance • Validate Databases • Ensures proper data collection and reporting • Perform for both the data collection database and associated edit checks • Require independent review (programmers and other associates who did not develop the database should perform the validation)
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: • CRF Design Core Labs • Design
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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