- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
9. STATISTICS AND CALCULATIONS
The use of qualified biostatistical expertise is necessary before and throughout the entire clinical trial procedure, commencing with the design of the protocol and case-report forms (CRFs) and ending with the completion of the final report and/or publication of the results.
The sponsor and the investigator should agree where and by whom the statistical work should be carried out. This information and the name of the responsible statistician should be recorded in the protocol.