Study Closure

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IRB Closure

Definition

  • IRB closure is the process in which to document the completion or termination of a study.

Policies/guidelines

  • Studies can be closed with the IRB when the involvement of human participants ceases (interventions, interactions, observations, and the gathering, use, study, and analysis of identifiable private information, including specimens, are all complete).
    • Multi-center studies can be closed once the above-reference activities are completed at UMMC .
  • Final report must submitted to the IRB to close a study.
    • Expedited review for minimal risk studies.
    • Convened review for greater than minimal risk.

Templates/forms

  • Final report
    • Must be submitted via REDCap.
    • Must provide a summary of the research activities and any findings available at that time.

Training