Training & Support

Topics

Topics

11.0 Study Management - Site Study Personnel

11.2 Request Compassionate Use

Duration • 13 Minutes

Applications can be made to participate in any clinical trial, or for compassionate use (in all of its forms globally) of any treatment used on an active study.

Compassionate Use

Apply for compassionate use of an investigational treatment

Users can submit a compassionate use request through the “Request compassionate use” icon, whether the treatment is offered via an expanded access program or a clinical trial. The application form auto-fills details from the site’s profile (contacts, physician credentials, lab info, IRB preferences, etc.) and collects anonymized patient information.

Once submitted, the request appears in the site’s application list, and the sponsor is notified to review, approve, or decline. Sponsors may also request additional information, with notifications sent back to the site for updates or re-submission.

Draft treatment plan:

For compassionate use applications, users can define a proposed treatment plan involving the investigational product(s). Clinical summaries can also be captured in the ‘Patients’ tab or as part of an application.

Other videos in this section

11.0 Study Management - Site Study Personnel

11.1 Request Study Participation

Duration • 14 Minutes
11.0 Study Management - Site Study Personnel

11.3 Managing Applications

Duration • 5 Minutes