Site Close-out

Site close-out is the final step in the clinical trial process and marks the end of the study activities at a particular site. The main objective of site close-out is to ensure that all study-related activities have been completed, that all study-related materials have been collected and stored, and that the study site is left in a compliant state.

The following are some of the key responsibilities and activities related to site close-out:

1. Study Completion: The study should be declared completed by the sponsor and the study personnel, and the last subject’s last visit (LSLV) should be recorded.
2. Study Data Review: The study data should be reviewed and validated, and the CRFs should be completed and checked for accuracy and completeness. The source data should be verified, and any discrepancies should be resolved.
3. Study Materials: All study-related materials, such as investigational drugs, study documents, and study equipment, should be collected and returned to the sponsor or properly stored.
4. Archiving of Study Materials: The study-related materials should be archived in accordance with the study protocol, the relevant regulations, and the sponsor’s standard operating procedures (SOPs). The study archive should be maintained for the required period of time, as specified in the relevant regulations.
5. Study Reports: The final study reports, such as the CRF and the CSR, should be prepared and submitted to the sponsor and the regulatory authorities, as required.
6. Site De-identification: The study site should be de-identified by removing any study-related information, such as study posters, study forms, and study signage.
7. Site Audit: The study site should be audited by the sponsor or the monitoring personnel to ensure that the site close-out activities have been completed, that the study-related materials have been properly stored or returned, and that the study site is in a compliant state.

Site close-out is a critical step in the clinical trial process, and it is important to ensure that all study-related activities have been completed, that all study-related materials have been collected and stored, and that the study site is left in a compliant state. The site close-out procedures should be performed by trained and qualified personnel, and they should be reviewed and audited regularly to ensure their effectiveness and compliance.

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