neuron


PTMS WILL PERMANENTLY CLOSE TO NEW SUBMISSIONS ON DECEMBER 20, 2018. WHEN USING CNS IRB GUIDANCE AND TEMPLATES, PLEASE REMEMBER THAT IRB SUBMISSIONS AFTER DECEMBER 24, 2018 WILL BE THROUGH IRIS.



Study Closure (SC) is used to close the protocol after participant enrollment, follow-up and data/specimen collection and analysis has been discontinued.

Common reasons for study closure:

  1. Completed: The study has been concluded, as described in the protocol.
  2. Premature Closure: The study was permanently stopped earlier than anticipated by the protocol for cause or futility.

NOTE: Once a study is closed, all research activity related to the study must stop. No participant activity (even follow-up) can occur. Data and samples from closed studies cannot be analyzed.

If additional data or sample analysis is desired, the data and/or samples can be transferred via amendment to an active "Repository" protocol. To assure continuity of research activity, the data and samples can be transferred to the repository protocol immediately before study closure.

The Principal Investigator is responsible for submitting a study closure action into PTMS. A study closure memo is required, which includes an explanation for closing the study, an assurance that all subject participation is complete, a plan for disposition of samples and/or data and statement of results.



Study Closure – Submission Checklist

Required Documents:
  • 1195-1
  • Study Closure Report/Memo
  • Protocol (last approved version)
  • Consent/Assent Forms (.pdf's from the CC Website; if they have been inactivated, the last approved version)
  • Inclusion Enrollment Report (Summary Minority Inclusion Report)*
Additional documents that are required, as applicable:
  • FDA Correspondence
  • Other Closure Notifications, as needed (RSC, Tech Transfer, etc…)

*These are not required by the IRB, however they are required by the Office of Protocol Services (OPS) before OPS will grant final NIH approval.