RWE 101 – Study Close-Out

Closing out an observational study involves several key steps to ensure that all study activities are concluded properly, and data integrity is maintained. Here are the typical activities involved:
[1] Data Lock and Validation: The first step in the study closeout process is to ensure all data is collected, cleaned, and ready for analysis. This involves resolving any outstanding queries, performing a final quality control check on the data, and then locking it for final analysis. This step also requires validation of data by checking the accuracy and consistency of the data collected.
[2] Disposition of Study Materials: Any remaining study materials, such as unused data collection forms or materials used for measurements, need to be disposed of appropriately. Any biological samples collected during the study also need to be handled as per the protocol and regulatory guidelines, which could mean returning, destroying, or continuing to store them, as agreed.
[3] Final Report Preparation: After data is locked and validated, the study team will analyse the data and prepare a final study report. This report content and format should follow regulatory requirements where applicable e.g., EU PASS Report.
[4] Archiving Study Documents: All study documents, including the study protocol, data collection forms, consent forms, and correspondence, should be properly archived according to the regulatory requirements and the company’s SOPs.
[5] Site Closeout Visits: If the study was performed across multiple sites, each site may need a closeout visit. These visits serve to confirm that all necessary activities have been completed, including data collection, storage or destruction of study materials, and archiving of site documents.
[6] Contract Closure: Finally, any contracts related to the study, such as those with study sites or service providers, need to be formally closed. This could involve confirming that all deliverables have been met, all payments have been made, and all obligations are fulfilled.
[7] Notification of End of Study: It’s important to inform the relevant ethical review board (IRB/REC) or regulatory authority that the study has ended, and provide them with a summary of the study’s findings, if required.
[8] Communicating Results: Depending on the nature of the study and its sponsorship, the results may need to be communicated to a variety of stakeholders. This could include the sponsor, study participants, health authorities, and potentially the wider scientific community through publications.
These activities help ensure that the study is closed out in a systematic and organized manner, which is critical for compliance, data integrity, and future use or inspection of the study data and materials. The exact nature and sequence of the activities may vary depending on the specifics of the study, the regulatory framework, and the procedures established by the sponsor.

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