This topic describes the process for documenting a clinical trial. This includes:
How all documentation generated for a study (at the site of the investigator and of the sponsor) gets compiled for a potential inspection by the competent authorities.
A clinical trial is organised to generate information to enhance the knowledge about a new or existing treatment. Information means data. The quality of the data needs to be good to ensure that the conclusions drawn from this data are reliable. Therefore, data collection, handling and storage needs to be controlled. This means that there must be a process in place that ensures reliable data collection and control. In clinical trials, ‘source documents’ and ‘case report forms’ (CRFs) are used for this purpose.