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

More documents

Recommendations

Info

Data Standards • Develop Data Management Plan • Provides a clear map for how data will be collected, stored, cleaned, protected and reported • Ensures understanding of required functions and study personnel responsibilities • Develop Edit Checks, Queries and Reports • Ensures data quality prior to analysis • Review how data points interact with other data points • Design with the final analysis in mind • Track queries to ensure resolutions are made in a timely manner • Develop database reporting tools to communicate with investigative sites, manage enrollment, visit data entry, outstanding queries and event reportings
Data Standards • Determine Access Control and Accountability • Prevents unexpected and unauthorized changes to the database • Databases should be equipped with audit trails so any changes, additions or deletions can be easily traced • Develop Data Recovery Strategy • Develop a plan and test it prior to data collection • Back-up databases routinely to ensure easy recovery if needed due to unexpected failures
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: Data Standards • Design effective
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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?