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Sunday, April 8 • 8:00am - 5:00pm
Workshop 6 - GCP 301: Audits in Biostatistics (1 day)

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RQAP re-registration units: 2 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

GCP Audits in biostatistics are a relatively rare occurrence, especially when compared to the vast number of investigator site audits in a clinical trial. Reasons for this include that biostatistics processes are done only once for a clinical trial regardless of the number of trial sites included and subjects enrolled. Also because of the strong focus on investigator site audits, many GCP auditors have little opportunity and therefore lack the knowledge to perform audits in biostatistics. The course offers a unique training opportunity for GCP auditors to be better equipped to assess data integrity and enhance inspection readiness in biostatistics.

At the end of the course, the participants shall be able to: 
  • Understand core procedures in biostatistics related to the conduct of clinical trials
  • Know the GCP regulatory requirements and expected documentation for biostatistics
  • Perform audits and identify deficiencies and weaknesses in biostatistics procedures followed in GCP trials

Target Audience
GCP auditors with an interest in broadening their audit portfolio and wish to assess processes in biostatistics. Experience in the conduct of GCP audits is expected for this course. Biostatisticians who are interested to learn what GCP auditors are looking for in such audits and would like to be better prepared for audits and inspections.

  • 08:00 - 09:00 Introduction, GCP Requirements pertinent to Biostatistics
  • 09:00 - 10:00 Overview on GCP Audits (preparation, conduct, follow-up)
  • 10:15 - 12:00 Auditing Biostatistics Processes (Part I): Protocol and Amendments, Sample Size Estimation, Randomization, Data Monitoring Committee
  • 13:00 - 15:00 Auditing Biostatistics Processes (Part II): Statistical Analysis Plan, Statistical Analysis Programming, Interim Analysis, (Blind) Data Review Meeting
  • 15:15 - 16:30 Auditing Biostatistics Processes (Part III): Unblinding & Final Analysis, Statistical Report & Final Report, Validation of Computerized Systems
  • 16:30 - 17:00 Wrap-Up, Questions & Answers
The course includes four exercises:
1. Protocol Sections on Statistics
2. SAP and Tracking Sheet
3. Table and Figure
4. CSR and Protocol Deviations


Rita Hattemer-Apostel

CEO/ Consultant, Verdandi AG
Rita Hattemer-Apostel is an expert in Quality Management and Good Clinical Practice Quality Assurance. Since 1994, she has performed more than 700 audits worldwide in all clinical trial areas at sponsors, CROs, laboratories, technical service providers, clinical investigators and... Read More →
avatar for Allan Rosen

Allan Rosen

Chief Scientific Officer, Array Biostatistics
Allan Rosen, MS is Chief Scientific Officer at Array Biostatistics, a company which provides statistical and statistical programming services to the pharmaceutical, medical device, and biotechnology industry. He has over 35 years of experience in clinical trial research including... Read More →

Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 9

Attendees (2)