Investigator Site Close Out Procedures

The purpose of this SOP is to describe close-out procedures for clinical trials monitored by the KHPCTO in order that clinical trials sponsored or co-sponsored by King’s Health Partners comply with the Medicines for Human Use (Clinical Trials) Regulations.

Close-out is defined as the act of ensuring that all clinical trial related activities are appropriately reconciled, recorded, and reported at the end of a trial in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirement(s).

Close-out is integral to the quality control of a clinical trial and is designed to ensure quality of the study according to Sponsor requirements and to ensure that all necessary documents are in place should it be necessary for the trial information to be retrieved or inspected in the future.

SOP: Investigator Site Close Out Visit(303k)

Related Templates

Close-out Visit Report Template

Remote Close-out Checklist

Database Lock Authorisation