Where to file thes

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    • October 21, 2020 at 4:12 am #3801
      Mariz Hanna
      Participant

      Hi All,
      I need some help where can we file the following:

      • ETDRS Logs
      • Study Supplies Log
      • Subject Stipend Accountability Log
      • Visual Acuity
      • Other Site Logs

      Please advise.
      Thank you
      Sincerely,
      Mariz Hanna

    • November 11, 2020 at 3:56 pm #3845
      Richard Golden
      Participant

      by study supplies, do you mean IP or non-IP? if it’s IP, I would use 6.1.5, if it’s non-IP, i would use 6.5.3

      as for the ETDRS and visual acuity logs, it may be a toss-up between 5.4.11 (source data) and 5.4.13 (eligibility).

      I’ve never seen a stipend accountability log in the TMF – if the sponsor insists on including it, I’m thinking 5.4.7

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