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
The decision to close-out a study should be an agenda item at one of the regular operations/communications meetings between sites. Close out of a teletrial might take place a few months or up to a year after the final patient visit at your site.
During study close out, the Investigator must supervise all staff performing close-out activities to ensure they are undertaken following the Sponsor requirements, delegation log and Supervision Plan. Ensure the Satellite Site supervision Plan is followed regarding disposition of Essential Documents during the study.
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.