Chapter VIII CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS
United Kingdom
- 47Compliance with the protocol and good clinical practice
- 48Monitoring
- 49Suitability of individuals involved in conducting the clinical trial
- 50Suitability of clinical trial sites
- 51Traceability, storage, return and destruction of investigational medicinal products
- 52Reporting of serious breaches
- 53Other reporting obligations relevant for subject safety
- 54Urgent safety measures
- 55Investigator's brochure
- 56Recording, processing, handling and storage of information
- 57Clinical trial master file
- 58Archiving of the clinical trial master file
- 59Auxiliary medicinal products