Submitting Documents with Track Changes

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Recently, I have come across several instances where applicants or regulators have discussed submitting documents with tracked changes. Clearly, there is some guidance for this in the area of EU and US labeling, but this was the first that I had heard of it potentially being done elsewhere in a dossier.

The first was at DIA, where Norman Schuff of the FDA recommended submitting Module 3 replacement documents with tracked changes shown.

Later, I encountered a sponsor that said that they needed to submit modified protocols showing tracked changes in the US., for their eINDs. They also indicated that some European authorities are asking for these “tracked changes” documents. The different authorities require some combination of this “tracked changes” protocol, an updated protocol incorporating amendments, and an amendments document (basically an errata listing and justifying changes).

I consulted several colleagues, and they all shared my thoughts – most sponsors go out of their way to ensure that documents don’t contain tracked changes, several of them having been “bitten” in the past due to legal issues around retaining tracked changes. In fact, some have investigated techology solutions for removing tracked changes – for example, see the PleaseTech product PleaseErase.

For sponsors using EDMS and PDF renditioning tools, there may also be issues around generating renditions showing tracked changes, if the copy of MS Word on the rendition server is set up not show tracked changes. At best, it seems like something you would want to do “sometimes” – and rendition servers, like other computer elements, like to operate off rules.

Are any of you out there in the sponsor community submitting documents other than labeling with tracked changes showing? If so, I would love to hear your background and thoughts on this topic!

Author: GS

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