Guidance

Useful Resources

Updated 6 November 2023

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This publication is available at https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications/useful-resources

1. General

Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)

The Medicines for Human Use (Clinical Trials) Regulations 2004

2. Non-clinical

ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals [EMA/CPMP/ICH/286/1995]

OECD Guidelines for the Testing of Chemicals: Section 4

OECD (1998), OECD Principles on Good Laboratory Practice, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 1, OECD Publishing, Paris

3. Clinical

Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3)

Clinical Trial Facilitation Group (CTFG) Recommendations related to contraception and pregnancy testing in clinical trials

EMA website Q&A: GCP WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products

4. Pharmaceutical

Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products, EMEA/410/01 EudraLex Volume 4: EU Guidelines to GMP for Medicinal Products for Human and Veterinary Use, Annex 13: Investigational Medicinal Products

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