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

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• Managing data Blinding • Limit access to data • Develop list of assigned personnel and their roles • Limit printing of data including where to print • Shred printed items unless required for recordkeeping • do not place in trash (too easy for others to pick up and read) • Provide isolated area for data review, analysis, data entry, source document collection for safety monitoring • Use computer screen shades when working in open areas
Blinding • Safety monitoring • Limit access to incoming source documentation • Redact key identifiers (patient information, product usage)
Page 1 and 2: Quality Control in Clinical Trials
Page 3 and 4: Documentation • Most important to
Page 5: • During the study Blinding • U
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 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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