WIRB considers the study open at the site until a study closure report is received. Please complete the study closure form when:

1. All subjects have finished their final visits and follow-up and
2. The sponsor or sponsor representative has indicated the study is closed at your site and
3. If the study was conducted under a Federalwide Assurance, all data analysis at the site is completed.

WIRB will close the study upon receipt of the closure report.

In May 2006, WIRB began sending 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 subjects, 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 WIRB immediately to avoid a substantial gap in IRB oversight for the research.

The Board may conduct renewal review of a site up to 30 days prior to the study expiration date listed on the Certificate of Approval. Review is carried out if WIRB does not receive a study closure notice prior to renewal of the study (which, for logistical reasons, may be scheduled up to 30 days before the study expiration date). Review fees apply for the study renewal service. To avoid unnecessary reviews and fees, do not delay reporting a study closure to WIRB if the expiration date is approaching.

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