Home Forums Adopting the Reference Model 05.04.01 Subject Log Reply To: 05.04.01 Subject Log

Fran Ross

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!