1. GCP Processes
A TMF should be the complete documentation of all activities over the entire life of a trial, from beginning to end -- an accumulation of all records and processes.
2. Financial Aspects Of The Clinical Trial
TMF should be established right at the beginning of the trial, and maintained throughout the entire trial, including both at the investigator/institution's site, and at the sponsor's office.
3. Audit Function
TMF documents must be retained for at least 5 years, and must always be available for audit.
4. Quality Of Essential Documents
Four key words to remember for your TMF: Complete, Legible, Accurate and Unambigious.
5. TMF File Storage
You have to store TMF files electronically in the correct fashion. That means in a way which ensures that TMF files cannot be altered without authorization. An audit trial should be created which showcases changes, and it must be demonstrate that data has not been lost or altered.
6. Physical Storage
Physical storage facilities or processes must be secure, providing environmental control to protect from physical damage, enough space for storage, and confidential, safe, storage. All documents should be accessible and retrievable upon request.
7. Phases of TMF
Remember the three stage life of the TMF, the before trial documentation, during trial documentation and post-trial documentation. Consider the TMF a "living document" which is continually accumulated.
8. Proper Maintenance
Your TMF must be properly organized and maintained, and must always be complete. Keeping proper records and organizing them in the correct manner goes a very long way.