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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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Great question! Subject Log 05.04.01 is a general “bucket” record to account for the wide variety of trial types the Model serves. So, if the trial protocol or a trial plan dictates the need for any de-identified subject log, 05.04.01 is where it goes.
Please note the another record: Subject Identifying Logs at 05.04.10. These are generally held only at trial site as they usually identify the human trial participants.
As with any Model: “Your use may vary”. If that doesn’t clarify your question, please do let us know!
Fran
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