Clinical Research Operations

 Multi-Institutional Close Out Visit

Purpose: To define the process of a close-out visit at a participating site in a multi-institutional study

STEP 1: Prepare for Participating Site Closure

1. CCR Principal Investigator (PI) verifies site will be closed.
2. CCR PI sends notification of intent to close to participating site PI.
3. CCR Study Coordinator schedules the close-out visit.
   • Include a meeting with participating site’s Study Coordinator, PI and Pharmacist.
4. CCR reviews visit reports to identify all outstanding issues.
5. CCR sends study close-out visit confirmation letter to participating site.
   • Include instructions to resolve any outstanding issues prior to the study closure visit.
   • Notify site of missing regulatory documents and request their availability at close-out visit.
   • Remind site that local IRB notification closure is required at the close-out visit. The site should notify the local IRB in writing that their site will be closed as of close-out visit date and should include:
     • Number of subjects that were screened/enrolled
     • Verification that all subjects are inactive
     • Verification that all data collection has been completed
     • Indicate study materials have been returned to sponsor (or will be as of the close-out date).
6. CCR prepares the following documents to bring to visit:
   • Study Close-out Visit Checklist
   • Blank Study Close-out Visit Report
   • Data Correction Forms
   • Previous Monitoring Reports/Correspondence
   • List of outstanding issues
   • Directions to site and contact telephone numbers

STEP 2: Conduct Site Close-Out Visit

1. Verify Protocol Completion:
   • Ensure that all participating site subjects are off study and all study procedures are completed.
   • Review all Serious Adverse Events and ensure that all reporting requirements have been met.
   • Verify that all outstanding issues/action items from prior communications have been resolved.
   • Assess whether there have been any changes or events at the study site that have not been previously reported.
   • Assess protocol compliance and subject compliance.
     • Check that all subjects’ source documents are on file at the site.
     • All deviations should be noted on the deviation log.
2. Review CRFs:
   • Verify that all final CRF corrections have been completed and signed.
   • Verify all data queries (resulting from previously retrieved data) are resolved and are filed with the CRFs.
   • Verify that copies of completed CRFs are retained on site.
   • Dispose of unused CRFs (or discard per Sponsor’s SOP).
   • Review Close-out/Lock-out database if Remote Data Capture was used.
3. Review Regulatory Files:
   • Verify completion of study logs (Study Personnel Signature Log, etc.).
   • Check for completion of Investigator Regulatory File using Regulatory Document Checklist.
   • Verify that all regulatory documentation is up-to-date according to the date of the study close-out visit.
4. Review Informed Consent Documents (ICD):
   • Verify that there is a signed consent document for each subject.
   • Verify that all signed consent documents are retained and filed per the site’s standard filing process.
   • Determine if the consent documents have been amended; if so, that all subjects have signed appropriately.
5. Meet with Pharmacy:
   • Conduct accountability review of Investigational Product (IP).
   • Ensure that the drug accountability records are complete and accurate.
     • Each accountability form must be signed and dated by the Principal Investigator.
   • If required by protocol, IP should be returned using the proper process and forms as defined in the protocol.
   • If applicable, verify that all blinding envelopes/labels have been returned and do not remain on site.
6. Meet with Laboratory:
   • Assess laboratories for biological samples and arrange for shipment or destruction.
7. Meet with participating site research team:
   • Review Close-out visit findings.
   • Discuss procedure for submitting follow-up information and outstanding documentation, CRFs, etc.
   • Discuss data archiving obligations
     • Site should retain study files for at least 2 years past NDA filing approval/rejection and they should notify CCR staff prior to destroying or moving any files off site.
     • Site should provide the storage location of the files.
     • Site should notify CCR if they are notified of an audit or to review any data related to this trial.

STEP 3: Document Activities of Site Close-Out Visit

1. Send participating PI a study close-out follow-up letterdetailing:
   • Outstanding issues
   • Corrective actions
   • Follow-up actions
   • Timeline to resolutions
2. CCR prepares a study close-out visit reportincluding:
   • Site Status
   • Outstanding issues
   • Any other pertinent findings
3. File participating site report and closure letter in Regulatory Binder.
   • Send copy to sponsor