Reply To: Archiving eTMF with no in house eTMF solution

Home Forums Archiving Archiving eTMF with no in house eTMF solution Reply To: Archiving eTMF with no in house eTMF solution

Kathie Clark

Taking a step backward, you also need to have a good understanding of your data quality as part of the archiving process. Of course, some organizations do a better job than others in their TMFs, and that becomes obvious when an archive is created.

For example, if you do not have reliable data for every record for its artifact, study, country and site, it will be difficult to create an organized artifact. I have seen exports where site level documents were missing site numbers, and instances where the originating organization has assured the recipient that all information was coded into a file name, which proved not to be true.

So no matter the archive used, you will need to ensure that your data and documents are organized in a manner that will facilitate retrieval and inspection.

Also, quoting from MHRA GCP:

Minimum requirements for an eTMF system should enable appropriate
security to be in place, which would include role-based permissions for activities being undertaken through the use of secure passwords. Accounts should be created and deleted within a formal approval process and in a timely manner. This is analogous to the paper system where the TMF is kept in a secure location, with retricted access.

and from EMA Guidelines:

An external archive providing retention of paper documents or electronic media or electronic storage (e.g. cloud data centre) may be used for archiving of the TMF. When an external archive is used by the sponsor or
nvestigator/institution, they should undertake an assessment of the suitability of the facility prior to use and continue quality assurance measures once the organisation has been contracted. There should be a formal agreement in place between the sponsor/investigator/institution and the external archive. In cases the external archive has several storage locations, the sponsor and/or investigator/institution should ensure they are informed about the actual storage location of their TMF and notified if this changes. The agreement is recommended to include provisions for the situation of
the sponsor or external archive going out of business.