The use of institutional SharePoint bespoke site for a eTMF

[mcclave]

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?

Thanks

Andy

[skerridge]

Hi,

We would be very interested in any update on this question, relating to the use of SharePoint. We are also looking at options to move to either an in house or commercial eTMF system. We are also aware of the general requirements of eTMF systems needing to be audit trailed, access controlled and accessible to auditors and inspectors, and the points Andy has raised in the initial question. We are an academic CTU and are therefore limited in funding for this.

It would be useful to understand from an inspectors point of view or from anyone who has implemented a SharePoint system, and has subsequently been inspected, if SharePoint has the capability to meet GCP requirements.

Thanks

Simon

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?

Thanks

Andy