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Search results with tag "Clinical trial authorisation"
GCP inspection metrics 2018-2019 (12-02-21)
assets.publishing.service.gov.ukThe first critical finding was for Clinical Trial Authorisation (CTA). This concerned breach of UK Statutory Instrument 2004/1031 (as amended), Regulations 28 and 31, Schedule 1, Part 2, (8), (10) and (12). This consisted of the following main observations:
Clinical Trial Authorisation (CTA) Application …
www.ct-toolkit.ac.ukClinical Trial Authorisation (CTA) Application Flowchart Submission to MHRA Sponsor or legal representative submits a notification to MHRA Notification to MHRA