Clinical Trials Toolkit Routemap

Permissions & Approvals Obtained

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Trial Approvals Phase

Permissions & Approvals Obtained follows the R&D Submission station and precedes the Final Trial Management Documentation station. Ensuring that permissions and approvals are obtained is a legal requirement which is relevant to all trials. This station is part of the 'trial approvals phase' group of stations.

Permissions and Approvals Obtained

A trial may not begin until all the relevant permissions and approvals have been obtained and reviewed by the relevant parties, including the funder, where appropriate.

Clear evidence of the documents submitted to the relevant approval bodies (the submission package), and the documents subsequently approved, must be retained in the Trial Master File. This documentation enables auditors and inspectors to verify that all legal and good practice requirements for obtaining approvals have been met.

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