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Jason King-Andreini

Hi Maria, I would encourage you and your team not to look at the TMF RM so much as a rule book, but a personalized guide, and your organization’s agreed and documented interpretation of each of the classifications will be important. There should be a study specific version of the reference model sharing your organization’s placement – and most CROs are very open to helping and negotiating the tool with you for the study. It can be an investment – but speaking to the CRO gains insights like their SOP impact on where something ought to be filed and how best to file it. The Suitability of Facility document you are referencing – does, in my opinion and with no experience of your organization’s practice – seem an option for the location of the document. However, there is normally a suitability statement as part of the Pre Trial Monitoring evaluation report. Just some thoughts.