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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)?