Document content referencing multiple studies

[Christy Nini]

How do you all handle filing of documents that reference multiple studies? For example in a smaller company, study management meets with a vendor to discuss multiple studies they are all involved with and the meeting minutes reflect discussion across multiple studies. Would you file the meeting minutes with each study? If so, would you de-identify the different studies? Or, would you do something else?

[Todd Tullis]

Hello Christy:

I advise my customers (I am an eTMF/eISF vendor) to file such records only once, and to attribute them to as many studies as are relevant to the record. The studies are not de-identified and may be visible as record metadata in addition to being within the readable record content. In this way, the same exact record is never duplicated within the customers’ eTMF.

I have heard from a few customers some concern that if the TMF for Study A includes a reference to Study B, then there is a risk that an inspector may then expand scope of their inspection to Study B. While I can understand that perspective, I also assume that if the inspector does decide to expand the scope, there must be a good reason for it…and it is better for all parties (including patients) that such problems be identified early rather than late.

Todd

[Kathie Clark]

One more point to keep in mind is that you need to ensure your processes and technology support this properly. For example, say you have an Investigator Brochure linked to Study A and Study B:
* If Study A is finished and the TMF locked, what happens if there is a new version of the IB? Will it cause a change to locked Study A’s TMF?
* If you have a practice of storing your TMF in an external archive, and you remove Study A from the system, will it cause any change to Study B?
* If study A is one week from finishing and you update the IB, will it cause an inappropriate update to Study A (as you would not distribute a new IB at that point in the study)?

If you look at something like an unblinded safety document, there may be even more issues (what if the blind is lifted in Study A but still in place in Study B)?

[Jaclyn Verrow]

We try to avoid this as much as possible for the exact reason that Todd mentions above. We have had several meeting types that discuss multiple studies and we have recommended to those teams to break out into separate documents. If separate documents per study is not feasible, we would file the document in each of the study TMFs, but we do not de-identify.

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