Trial Master File and Essential Documents
The Trial Master File should contain all the Essential Documents required by ICH-GCP that are appropriate for your clinical trial. The Trial Master File can be thought of as a file storage system that orders all the regulatory documents and approvals that are required for your clinical trial. This may be in the form of a single file or a more complex filing system (a series of cabinets etc.) depending on the complexity of your trial and the requirements of the approvals process. If a complex filing system is needed you may consider developing a Document Management System. Case report forms and source documentation should be kept with the Trial Master File in an ordered, readily accessible and controlled manner. This is an important part of the quality system and will make any monitoring and auditing easier to conduct.
The following resources may be useful in helping you set up a Trial Master File and identifying the documents that should be present. However, bear in mind that this is an extensive list and not all documents may be required depending on the nature and extent of the trial and your local regulatory obligations.
1. ICH-GCP Essential Documents Table
2. Trial/Research Studies Master File, SOPS and Templates: http://www.admin.ox.ac.uk/rso/clinical/downloads.shtml
3. Imperial College London, SOP on Trial Master File and Essential Documents checklist: http://workspace.imperial.ac.uk/clinicalresearchgovernanceoffice/public/JRO%20SOP%20005%20TMF%20Guidance%20Controlled%202010.pdf
4. Information on setting up a Trial Management System: http://www.cttoolkit.ac.uk/_db/_documents/Trial_MS.pdf
5. Regulatory binder table of contents and structure
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