#25 Practical RWE – Study Closure


Closing a non-interventional (observational) study involves several key activities to ensure the study is concluded ethically (and respectfully), the data is handled appropriately, and findings are disseminated (shared) effectively. These activities can be grouped into several categories:

  1. Data Management and Analysis: Ensure all data collection is complete, including any follow-up information. Check the data for accuracy, completeness, and consistency. Perform the final analyses as per the statistical analysis plan. Once the data analysis is complete and verified, the database should be locked to prevent any further changes.
  2. Ethical and Regulatory Compliance: Inform the ethics committee(s) (and competent authorities where applicable) about the study’s completion according to national reporting requirements and timelines.
  3. Documentation and Reporting: Prepare a report that includes the study objectives, methodology, results, safety data and conclusions. Plan for the publication of study findings through scientific articles, conference presentations, and reports to stakeholders (participants, patient advocacy groups, etc.). Notify the relevant public databases (e.g., clinicaltrials.gov) that they study has closed and provide a summary of the results and/or links to publications.
  4. Study Close-out Visit (if applicable): For studies with physical sites, if needed, conduct close-out visits to ensure all study-related materials are accounted for (e.g., unused data collection tools) and to debrief site staff. One of the (many) benefits of observational studies is there is no drug…and therefore no need for drug reconciliation.
  5. Participant Communication: Notify participants (patients) about the study’s completion, thank them for their involvement and share the results with them.
  6. Financial and Contractual Closure: Ensure all financial matters related to the study, such as payments to vendors or sites, are settled. Review and close any contracts related to the study, ensuring all obligations have been met.

Each of these activities requires careful planning and execution to ensure the study is closed responsibly and efficiently. The specifics may vary based on the study’s design, the national regulatory requirements.

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