The GCP provide in fact that the "Trial Master File" must contain a summary document for each person involved in the trial. If this document has been drafted by the biologist as advised by the decree of 26 November 1999 relating to the proper performance of medical biology analyses, it must indicate:
- the different results with the date and time of sampling and the time of performance of the tests,
- control sample results with the same time series information,
- any comments and incidents that may have occurred.