Study Close-out

When a study meets the criteria for closure, IRB oversight is no longer needed and a study may be closed with the IRB.

VCU IRB oversight may end (following a request for closure) only under the following circumstances and conditions:

  1. The research is permanently closed to enrollment at the site(s) under the VCU IRB approval; and
  2. All interactions/interventions with subjects, or access to a subject’s personally identifiable information, (including identifiable biological specimens) for the purpose of research data collection is complete; and
  3. (a) All use, study, and/or analysis of identifiable private information at the research site(s) under the VCU IRB approval is complete.

NOTE: For multicenter studies: Continuing review of the research by the VCU IRB is no longer required once the above conditions are met (following a request for closure), even if (i) interactions or interventions with subjects may be occurring at study sties other than those under the VCU IRB approval; or (ii) data analysis of identifiable private information is ongoing at another central site (site other than those under the VCU IRB approval) that collects and analyzes data from all study sites. For studies closed with the VCU IRB under these conditions, investigators may still respond to queries from the statistical center at the other institution regarding previously collected data about subjects who were enrolled under the VU IRB approval.

Procedure for Closing a Study

Electronic (RAMS-IRB) Studies: To close a study in RAMS-IRB, open the study workspace for the study you wish to close and initiate the close study activity. Alternatively, a study can be closed at the time of continuing review by selecting the close study option within the continuing review activity.

Paper Studies: To close a paper study, submit a study closure form to ORSP.