05.04.01 Subject Log

Home Forums Adopting the Reference Model 05.04.01 Subject Log

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      Patricia Fulton
      Participant

      In ICH 8.3.20 Subject Screening Log is noted as being located in Investigator Files and Sponsor Files (where required). ICH 8.3.22 Subject Enrolment Log is noted as being located only in the Investigator File. In the DIA Reference Model 05.04.01 Subject Log (examples Subject Consenting Tracker, Subject Enrollment Log, Subject Loc, Subject Screening Log, Subject Visit Log)- it is noted as being a Sponsor and an Investigator Document (columns M,N,O,P). Can you clarify why it is noted this way in the reference model, and how we should interpret the model in this case?

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