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Regulatory Binders

Each department conducting a clinical trial must keep a binder(s) containing every piece of documentation pertaining to the trial.

  • All written Correspondence with sponsor, including e-mails
  • Copies of all the regulatory documents submitted
  • Approved Informed Consents
  • Notes to file
  • Screening/enrollment Log
  • Monitor Sign-in
  • Delegation of Authority

Regulatory binders, for non industry sponsored trials, will be provided to the research teams upon study activation.

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