The Sponsor Lead Pharmacist will be required to keep all correspondence and documentation related to the trial for a specific section of the Trial Master File for regulatory purposes.
This section will be collated to the overall Trial Master File at the end of the trial, according to the Sponsor processes.
Archiving of the Trial Master File must be done in accordance with regulation and local procedures.
Final monitoring visit
As part of trial close down, Sponsor monitoring staff should perform a final monitoring visit to ensure the site trial folder is complete, and all deviations closed. Once complete the site may archive their folder in line with the relevant document retention requirements.