ECSubmissionOfApplication object

Responsible for study submission

Chief Investigator

Guidance on study submission available

Yes

Guidance on study submission

The 'Guidance on the Application for Recognised Ethics Committee Opinion and the Ethical Review of Clinical Trials on Medicinal Products for Human Use' provides detailed information on the submission of an application. Available on the Department of Health website in section: Policy A-Z>C>Clinical Trials Involving Medicinal Products.

Applicable national legal framework/ Reference

Regulation 12 SI 190/2004

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