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Central Adelaide Local Health Network Research OfficeClinical Research Agreement Guidelines 1. Introduction Each clinical trial to be conducted at a site within SA Health and sponsored by a third

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What is clinical trial document submission?

Clinical trial document submission is the process of submitting all necessary documentation and information required for a clinical trial to regulatory authorities for approval.

Who is required to file clinical trial document submission?

The sponsor or the principal investigator of a clinical trial is required to file the clinical trial document submission.

How to fill out clinical trial document submission?

To fill out a clinical trial document submission, the sponsor or principal investigator must provide detailed information about the study protocol, participants, risks and benefits, and other relevant data.

What is the purpose of clinical trial document submission?

The purpose of clinical trial document submission is to gain regulatory approval to conduct a clinical trial and ensure the safety and well-being of participants.

What information must be reported on clinical trial document submission?

Information such as study protocol, informed consent forms, investigator's brochure, data collection forms, and safety monitoring plans must be reported on clinical trial document submission.

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