Non-EDC Database documentation

[Jaclyn Verrow]

We use zone 10 for EDC specific documents. We now have other databases in use that we need to file Specifications, Validation and other documents specific to those additional databases. Where are you filing these in light of the EDC specific naming currently used in zone 10? Will renaming the zone to a more generic description be appropriate?

[Eldin Rammell]

Hi Jaclyn: So long as this question does not require you to provide confidential information, can you give a couple of examples of the type of database that you are referring to in your question? That might help to give a correct response. Thanks.

[Jaclyn Verrow]

Thanks Eldin. The types of databases I am referring to are Risk-Based Monitoring platform, Clinical Data Sharing Platform.

[Nick Hargaden]

Hi – If anyone has insight into this question I would be interested to hear. I know the ref model 3.3 has started to account for this – systems validated for use on the trial that are not EDC/CDMS or IRT – eCOA, devices, RBQM etc. Where do you file the requirements, UAT documents etc.?

Are TMF teams implementing a Zone 12 for this now, or filing everything in Zone 10?

Thanks!

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