Chapter 58

Study closure

WCG IRB closes studies and provides a confirmation of closure as outlined below:

  • When we receive closure notices for all remaining open sites and a directive to close the study. 

and

  • For the scenarios listed below, WCG IRB will automatically close the study when the last site/only site under WCG IRB oversight is closed:
    • Involves only one Investigator or site globally
    • Single patient expanded access
    • Exempt/NHS
    • Study termination or intent to close letter or memo reviewed by Board
    • Intent to close correspondence received from the sponsor or CRO
    • There are no current contacts designated to receive study notifications on file
  • For any situations not covered by the above bullet points, when the last open site under WCG IRB oversight closes and there is no directive from a sponsor or CRO representative, WCG IRB staff will proactively reach out to the sponsor or CRO to confirm whether the study should be closed as well. WCG IRB will hold the closure of the study for a maximum of 30 days while awaiting a directive to close the study. If no response is received after 30 days, WCG IRB will proceed with closure.

A notification like the one pictured below will be posted to ClinSphere® eReview Manager or IRBNet when WCG IRB has closed the study (a.k.a. protocol) in our system:

Please note that each Certificate of Action (COA) states “…the individual and/or organization shall promptly communicate or provide, the following information relevant to the protection of human subjects to the IRB in a timely manner: …Any findings from closed research when those findings materially affect the safety and medical care of past subjects. Findings will be reported for 2 years after the closure of the research.” More guidance about required reporting of post-study activities can be found on the WCG Clinical Website here.

The approval period expires at 11:59 p.m. on the expiration date cited in the current Certificate of Action.