![]() The Annex 2 form, which is available on the MHRA website, can still be completed and submitted to the MHRA for ‘bulk’ amendments, where the same change will affect many trials simultaneously. The MHRA will now accept a copy of the completed Amendment tool when notifying amendments to a single CTIMP. ![]() All amendments to CTIMPs that require notification to the MHRA will no longer require the submission of a European Commission “Annex 2” form.On 25 March 2021 the following changes to how amendments are processed will apply For guidance relating to clinical trials of investigational medicinal products (CTIMPs) and medical devices please refer to the Medicines and Healthcare products Regulatory Agency (MHRA) website.Please refer to the Health Research Authority (HRA) website for guidance about Research Ethics Committees (REC) and NHS/HSC arrangements.Guidance for sponsors, sites and researchers.
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