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Trial Master File


This question is really for myself to understand more of a clinical trial.  I wonder if many of you create and use  Trial Master File, and if so, do you make a digital version as well?  And if so, how does it interact with OC if it does in some way?



  • vidyadharpujarividyadharpujari Posts: 11

    Yes, we create and maintain trial master file for regulatory and to organize all the records related to clinical trial. We don't create a digital version of the trial master file, we maintain it in paper format. OC does not have any functionality to support this type of operation. It actually comes under clinical trial management Systems (CTMS), in which people maintain trial master file, financial records, monitoring reports etc. A CTMS software can be integrated with OC to maintain the trial master file.

    Hope this helps.


    Dr. Vidyadhar S Pujari
  • cra360cra360 Posts: 56
    Dr. Pujari,

    Thank you for your thoughtful note on Trial Master File.

    Best regards,

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