PRO Scripts and Site Activation Checklist

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      Kathleen Kane

      I have two questions regarding where to file a couple of documents:

      1. Patient Report Outcomes (PRO) scripts for PROs conducted over the phone. Should this be filed with other subject questionnaires in 02.02.02?

      2. The study team fills out a site activation checklist that the study team fills out to confirm that the sponsor/CRO has received all required essential documents prior to activating a site on a trial or shipping IP. Where should this be filed? Or is this type of documentation not typically filed in the TMF?

      Thank you!

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