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:

  1. Data & Documentation – ensure all required data has been collected and verify that study files are updated and complete.
  2. Drug Accountability – finalise accountability and disposition of Investigational Product.
  3. Signatures – Collect final signatures on any logs or reports.
  4. Discussions & Decisions – discuss overall study conduct and achieving at the site.
  5. Clean House – dispose or return any trial specific supplied or samples.
  6. Formally close out sitenotify HREC and/or RGO that study has been closed.

Archiving

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.

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