We are in the setting up phase of a clinical research study and we are exploring the use of SharePoint as a potential eTMF, we are a University CTU with an institutional SharePoint licence. We can create a secure space which only those who have rights to access will be able. The system holds all the metadata for the documents and history of any changes or moves.

All the documents will be created in the Microsoft environment and would streamline processes and avoid duplication.

This will enable us to update our SOPs to move away from the paper TMF and reduce points of failure in record keeping. The site can be given an auto archive date and the cost of the site in free to the clinical trials unit and to the studies we support.

Would this be acceptable for MHRA and GCP standards?