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Plan for closure

Information:

  • Closing out a study can be complex. It is important to note that each entity involved in your study – the IRB, the FDA, Research Management, etc. -- may have its own set of requirements and timelines for managing this phase of a clinical research project. Review these requirements and outline your process at least six months before study closure so that you are clear about what steps need to be taken and who will be responsible for each task.
  • A study can be closed after the last subject completes his/her final study-encounter.
  • Studies must be closed with the IRB. In order to properly close a study, a final report must be submitted to the IRB via the continuing review process.
  • If your study is a drug, device or biologic study overseen by the FDA, the sponsor will collect the final study agent accountability logs and will require a close out visit and report. Check with the study sponsor to determine if your investigational product is to be returned or destroyed. There may be a charge for product destruction. Ask for a receipt or email documentation of destruction completion.
  • To close-out a study, remember to complete the following tasks as applicable:
      • Plan for study closure communications with study subjects
      • Inform the Research Pharmacy that the study is complete
      • Resolve any outstanding queries from the study sponsor
      • Schedule a close-out meeting with the monitor/sponsor
      • Submit a final report to the sponsor as per the terms of your contract
      • Submit any outstanding charges to the sponsor
      • Reconcile study finances with the sponsor
      • Label and ship frozen specimens
      • Return/discard remaining lab supplies
      • Notify the IRB of close-out and submit final report
      • Organize and archive case report forms and regulatory documents per storage requirements
      • Report results to clinicaltrials.gov (if applicable)
      • If CRFs have been electronic, request hard copies or CDs from sponsor
      • Verify that all regulatory documentation, including IRB documentation, is complete

Resources:

▪ MGH Clinical Research Program IRB Submission/Ongoing Support
MGH Clinical Research Program Study Completion Checklist
Partners QI Program Guidance for Clinical Research Study Close Out
Partners Research Finance: Closeout a Fund
Partners Research Management Operating Procedures: Award Close Out

Courses:

ONLINE:
Good Clinical Practice and Study Management Basics
Introduction to Clinical Research at MGH

LIVE TRAINING:
Good Clinical Practice in Research at an Academic Research Institution
Reporting Results: Should Subjects Be Told Clinical Research Results?

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