Study close-out is an essential factor in a clinical trial study. This process ensures that all the clinical trial activities are rightly reconciled, recorded, and reported at the end of the study trial. Usually, a study trial is considered closed by clinical research companies when the study report is finalised and the database is locked.
Why is study close-out important?
Study close-out is essential because of regulatory obligations, to keep track of the resources invested, to answer the research questions, and finally, for the contribution of generalizable knowledge and better medical care.
3 key areas in clinical trials which require immediate attention once the research is completed:
- Document Management, Storage, and Retention: Once your research study is completed, you need to ensure that all the related study documents are maintained and stored in the research site for at least a year or as mentioned in the study contract Federal Regulations guidelines.
Post this period, and the study documents need to be archived properly in an off-site location. The documents should remain retrievable for another seven years or as mentioned in the study-specific agreement.
- Study Close-out Report: It is critical to submitting a study closeout report to the IRB while closing a trial study. The report is meant to inform the IRB about the study closeout activities, including study outcomes and any problems that might have arisen.
The report is to be written by the sponsor in case of a sponsored trial or an investigator if the investigator-initiated the study. The study report should include any record of serious adverse events or unexpected events if the study goal was achieved.
- Result Submission: The study must be first registered with ClinicalTrials.gov before publishing the results. The principal investigator has the sole responsibility to provide and maintain study-specific reports.
Listed below are the 6 different components of the study close-out checklist:
- Monitoring visits: Ensure there are site close-out visits in the sites participating in the clinical trial. Usually, there are two types of visits – Local QA and NIDA CCC. During a monitoring visit following items need to cover.
During a closeout visit, things required to be covered includes data integrity and query resolution, adherence to regulatory requirements, disposition of study material, etc. Know that close-out may not occur until the last participant the last visit has occurred.
- Study personnel: For any staff no longer participating in the study trial, an updated staff information form needs to be sent.
- Safety and regulatory: Ensure you have done all adverse event reporting. All protocol deviations must be reported too. Ensure you have completed all the regulatory files and have uploaded all the documents to the regulatory tracking system. If any action item is pending, ensure to close it before site-close out.
- Data cleaning: The success of a clinical trial depends on the quality of the data. Hence, ensure the data integrity is maintained throughout the clinical trial process. Generate data quality reports towards the end of the study trial and at close-out.
- Medication, supplies, equipment: Understand who has disposition authority and include it in the site closeout checklist. Start working towards maintaining a low supply inventory once you are approaching the study closeout. Know that while you can donate certain supplies like lab kits, needs, gel packs, shipping boxes, etc., you need to destroy medication wallet cards, waybills, prescription labels, etc.
- Storage and data retention: You have all the source documentation in one place. Ensure that for paper studies, all CRFs are completed, collected, and the legible copies are available in your study files. For electronic data, confirm that all electronic CRFs have been completed and submitted.
Wrapping Up:
Study close-out is an essential factor in concluding clinical testing successfully. This checklist will ensure you do not miss out on the vital points of study close-out.