The Importance of Closing Your Research Study
Your research study is considered complete and ready for closure in IRBNet once all of the following criteria are met:
- The study is permanently closed to enrollment.
- All subjects have completed all study-related interventions.
- The collection of private identifiable information is complete.
- Analysis of private identifiable information is complete.
Do not allow the study to simply expire or miss the Next Report Due Date even if the research is complete. The protocol should be formally closed. Allowing a protocol to expire or the Next Report Due Date to lapse may be perceived as an indicator of non-compliance. In addition, formally closing the protocol allows the audit and records retention timelines to begin.
Faculty listed as Faculty Sponsors on any student research project need to know that they are responsible for ensuring the closure of a completed research project or upon the graduation of the student. Working directly with the student to have them complete the closure process and securely store the study records, is best practice. If that does not happen, the faculty sponsor will be required to submit the closure on the student’s behalf.