December 17, 2019 at 10:50 am #2737Ishita MehtaParticipant
We’re in the process of implementing an eTMF system within our company and have had multiple discussions surrounding the location of financial agreements. I would just like to obtain some guidance and/or information as to what routes other companies have adopted instead of uploading the financial agreements into the eTMF? What is the standard expectation that needs to be followed if a financial agreement is kept outside of the eTMF? We of ‘course are aware that if they are kept elsewhere, the location of these would need to be highlighted in the TMF Management Plan, however it would be immensely useful to get some examples surrounding this topic. Another concern was relating to overarching financial agreement for a vendor that covers multiple studies and where to store these, if uploaded within the eTMF.
January 3, 2020 at 1:55 pm #2767Ishita MehtaParticipant
Does anybody have any thoughts on the above?
January 3, 2020 at 2:32 pm #2768Irene MiddendorfParticipant
Hello Ishita, Our company policy has always been not to file financial documentation in the eTMF. We utilize a separate database to store all contracts/budgets and as you mentioned above, document this location in the study specific TMF plans. If required, financially redacted documents are provided to auditors. This would also apply to overarching agreements that may span across multiple studies.
January 3, 2020 at 2:44 pm #2769Eldin RammellParticipant
My comments would be applicable to any document considered to be part of the TMF but kept outside the main eTMF/TMF.
- The documents must be included on the TMF Plan / TMF Index, together with the identification of the storage location/system
- The documents must be capable of being made readily available in the event of an inspection or audit; this includes being able to easily identify and retrieve relevant documents by study number, site number and/or PI name, as appropriate
- The documents must be accessible to relevant team members to confirm relevant quality standards and completeness requirements have been met
- The documents must be retained in accordance with GCP requirements, including transfer to an archive under the control of an archivist for the period of time required by pertinent regulations
- There must be a reasonable rationale for storing the documents in a system other than the main eTMF/TMF
For documents such as Master Service Agreements that cover multiple studies, sponsors who file these in the TMF usually have a level of filing above study level or file an electronic copy in each applicable TMF. I think there is likely to be a majority of sponsors who file MSA’s outside the TMF, in a contracts management system.
Hope this helps.
January 3, 2020 at 3:05 pm #2770Kathie ClarkParticipant
One more point – if you do keep these in your eTMF, there probably needs to be a way to restrict access to people with a “need to know” – as financial information is often considered sensitive and access may be limited to a subset of eTMF users.
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