Last week, we covered the concept of a TMF map and discussed the importance of mapping the TMF over time. Today, we're going to consider what happens to our various TMF repositories post-archival.
At some point in time after a study is completed, most sponsors move the documents in their primary TMF repository to a read-only archive. This may involve flipping a switch in an eTMF that prevents users from making additional updates, or it may involve moving electronic documents from a full-featured eTMF repository to a read-only repository with limited features. When we complete this archival process, we need to think about what will happen to the TMF documents that are located in different repositories.
Ideally, all repositories of TMF documents are validated, access-controlled, and protected for the entire retention period - but we don't live in an ideal world. For example, vendor contracts are sometimes maintained in a contracts database. Curriculum vitae are frequently maintained in an HR system. Statistical deliverables may be held on a shared drive. Are there processes in place to ensure these documents are retained for the entire retention period? If the company moves to a new contracts database, HR system, or shared drive, would the migration plan include protections for regulated documents? If the sponsor were acquired, would these documents be treated as Trial Master File records?
Although there is no prohibition against using multiple TMF repositories, the ease with which documents can disappear after the study is closed and forgotten by everyone (except the regulatory authorities) is a strong argument for consolidation into a single protected repository. If this is not possible, then teams should consider whether ancillary repositories are adequately protected for the retention period.
E6 R2 currently states that essential documents should be retained "until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product." It's tough to proceduralize "contemplation," and even tougher to apply "contemplation" to multiple repositories. This wording has been removed in draft E6 R3 in favor of local retention requirements, so when the draft is finalized, this may simplify retention procedures.
