9. Study close out
Closing a teletrial involved ensuring that all clinical research activities across all sites are appropriately recorded, reported and reconciled. This page provides an overview of the processes related to close-out of a teletrial at all sites and the achieving process at the end of a teletrial.
For more information on study close out, read SOP 13 in the National Standard Operating Procedures for Clinical Trials including Teletrials. Access the National SOPs
Close out of a teletrial might take place a few months or up to a year after the final patient visit at your site.
A final close-out can only be completed when the Sponsor has reviewed all the Investigator/Institutional files and confirmed all required documents are appropriately filed. The Sponsor then notifies the Investigator in writing that a close-out can commence.
Study Close Out Checklist
Follow the Study Close Out Checklist below to help with closing out a teletrial:
- Data & Documentation – ensure all required data has been collected and verify that study files are updated and complete.
- Drug Accountability – finalise accountability and disposition of Investigational Product.
- Signatures – Collect final signatures on any logs or reports.
- Discussions & Decisions – discuss overall study conduct and achieving at the site.
- Clean House – dispose or return any trial specific supplied or samples.
- Formally close out site– notify HREC and/or RGO that study has been closed.
Study documentation is to be achieved as specified in:
- (i) the Australian Code for the Responsible Conduct of Research. Part A, section 2.1
- (ii) ICH GCP E6 (R2) 4.9.5, 5 and 5.12
All archived material should be enduring and protected from damage or destruction in a controlled environment and access should be restricted to authorised personnel only.