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
- All participants have finished all protocol related interventions, interactions, final visits, and follow-up; and
- The sponsor representative reports the study is closed at your site or permanently closed to enrollment.
- 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.