- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
11.2 On-site inspections
As permitted by national regulations, the drug regulatory authority may carry out on-site inspections of the clinical trial site. Such inspections may be carried out routinely, randomly and/or for specific reasons, and should consist of a comparison of the procedures and practices of the investigator with those set out in the protocol and reports submitted to the drug regulatory authority by the investigator or the sponsor.
The inspection should determine whether the investigator has custody of the required records or, if not, who has assumed this responsibility. The data archives should be tested for ease of retrieval.
Inspections may include data audit. The drug regulatory authority should have easy access to all patient files and raw data used for and generated during the trial.