Compilation, review and maintenance of Trial Master File/Investigator Site File (TMF/ISF) is being performed according to ICH GCP requirements, which requires, that documentation contained within the TMF/ISF should be sufficient to reconstruct the trial activities undertaken, along with the key decisions made concerning the trial.
To assists the successful management of a trial by the investigator/institution and the sponsor, TMF is maintained with all documentation added in a timely manner during the trial and ensuring that all clinical trial information is recorded, handled, and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of the trial subjects remains protected.
Quality checks (QC) and review processes are implemented to ensure the TMF is being maintained up-to-date and that all essential documents are appropriately filed in the TMF. The main QC and review areas include the following:
• Availability in TMF/ISF of all essential documents generated during the course of the trial;
• Documents filed in the appropriate locations;
• Documents added to the TMF in a timely manner;
• Accurate version control is being kept of all trial related documents including Protocol, Patient Information Sheet (PIS), Informed Consent Form (ICF), Investigator Brochure (IB), trial specific procedures and Standard Operating Procedures (SOP);
• Documents only accessible according to the assigned roles and permissions.