Dinner Meeting: November 1999

Speaker: Mary Ann Gorko
DuPont Pharmaceuticals
Title: Incorporating Statistical Methods into Auditing Clinical Data Listings


Members of the Biometrics and Quality Assurance staffs met to discuss improvements in the audit process for clinical data listings. With the advent of the International Conference on Harmonization (ICH) good clinical practices (GCPs) they were concerned about assuring that the procedures and processes for managing incoming clinical data and reporting to regulatory agencies were appropriately rigorous to ensure complete and accurate processing of clinical trial data.

This talk describes a statistically based audit plan that takes into consideration the phase of the trial, the importance of the trial to regulatory filings, and key study variables. The audit plan also includes a procedure for randomly selecting studies and patients for audit, and establishes statistically based acceptance and rejection criteria. This audit process has been in use for two years and has resulted in more efficient planning and execution of clinical data audits. Due to the randomness of the process and high standard for acceptable quality levels (AQL), interval quality control (QA) procedures have been strengthened to assure that all data listings meet these standards.


Thursday, November 11, 1999

Social hour -- 6:00 pm
Dinner -- 6:30 pm
Speaker -- 7:15 pm

Newark Holiday Inn
Oliver's Restaurant

$20 for members, $5 for students

Reservations to Jane Buck by Friday, November 5, 1999.
410-885-3117,  buck@count.com

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