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21st Apr 2012, 07:58 AM
#1
using sponsor SOP for TMF
Dear all,
I work for a CRO who manages its documents through a proper SOP for study file. Now, a pharmaceutical company is asking to follow its TMF SOP.
In our current SOP, we list the most important documents that we can produce, so my idea was to add a field in which to allow the archive manager/project manager to map each documents vs the TMF SOP of the pharma company. In this case we will have only one study file and at the end we can easily take all the documentation needed for the TMF to be delivered. I would like to avoid to have two different files to be managed (one for the documents not needed in the TMF and one for the TMF)....
In this case, is it mandatory to have an ongoing TMF (and not mixed with our study file) or is it an agreement with the pharma company?
are there any suggestions that can help me?
Thank you very much for you help.
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