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Topics

12.0 Study Management - Sponsor

12.2 Authorisation

Duration • 0 Minutes

AnovaOS supports the uploading of documents for approved compassionate use applications.

Authorisation

Prepare letter of authorization:

A Letter of Authorization for approved compassionate use applications can be uploaded to the document register in the study or sent direct to the site administrator detailed in the application.

Note: Anova can provide sponsors with template documentation to support activation and enrolment to a clinical trial or compassionate use program.  For more details contact info.us@anovaevidence.com

Secure siganture:

Execution of a Letter of Authorization for approved compassionate use applications can administered with the site administrator detailed in the application.

Note: Anova can provide sponsors with access to a dedicated 21 CFR Part11 compliant eSignature system as part of their subscription.  For more details contact info.us@anovaevidence.com

Collect, review and approve investigator credentials:

Sponsors can view any investigator linked to a research site, listed in the study personnel registry, or listed as the eligible physician responsible for an application to participate in a clinical trial or compassionate use program.  Detailed CV, medical license(s) and training credential(s), regulatory disclosures, financial conflicts, areas of research experience and interest are all included as part of a study personnel record that can be accessed by the sponsor.

Other videos in this section

12.0 Study Management - Sponsor

12.1 Receiving Applications

Duration • 4.5 Minutes