Chapter 59

Study Closure

WCG IRB considers the study open at a site until a study closure report is received. A study closure report may be submitted when 

  1. All participants have finished all protocol related interventions, interactions, final visits, and follow-up; and 
  2. The sponsor representative reports the study is closed at your site or permanently closed to enrollment.
  3. If the study was conducted under a Federalwide Assurance for research participant to federal oversight other than FDA: No additional identifiable private information about the participants is being obtained and all data analysis at the site is completed.

WCG IRB will close the study upon receipt of the closure report. Submit closures via ClinSphere® eReview Manager (IRBNet clients can access a closure form from their IRBNet forms library.)

To avoid unnecessary reviews and fees, do not delay reporting a study closure to WCG IRB if the expiration date is approaching – renewal review is generally conducted 20-30 days before the expiration date; therefore, closure forms should be received before that window to ensure continuing review for the closing study is not carried out and billed.

WCG IRB sends closure confirmation notices to all study contacts upon receipt of a study closure form. Sites must have active on-going IRB approval in order to enroll participants, perform any study interventions, collect/report new data, and/or, if under an FWA, analyze identified data at the site. If you receive a closure confirmation for a study you believe was closed in error, contact WCG IRB immediately to avoid a substantial gap in IRB oversight for the research.

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.