H. References, Back to the index of the Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA

• Statutory instrument 2004/1031: The Medicines for Human Use (Clinical Trials) Regulations 2004 (https://www.legislation.gov.uk/uksi/2004/1031/pdfs/uksi_20041031_en.pdf).

• Statutory Instrument 2006/1928: The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (https://www.legislation.gov.uk/uksi/2006/1928/pdfs/uksi_20061928_en.pdf).

• See also MHRA GCP Guide 2012 (https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials)

Back to the index of the Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA, Medicines & Healthcare products Regulatory Agency

 

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