![]() ![]() PDF file of the Clinical Trial Authorisation application form* generated in IRAS with changes highlighted, if the amendment affects the information previously submitted.Alternatively, for ‘bulk’ amendments (where the same change affects many trials), the substantial amendment notification form** can be completed and submitted. You should ensure that the amendment tool contains a clear description of the substantial amendment and reasons for the proposed changes. A PDF copy of the locked Amendment tool.Covering letter detailing the trial reference numbers (IRAS ID, CTA number, EudraCT etc) along with Purchase Order Number, outlining the substantial changes (if there have been any non-substantial changes please also outline these separately).You need to send the following documents to the Medicines and Healthcare products Regulatory Agency (MHRA): Further details on how to register and submit via this platform. (d) the quality or safety of any investigational medicinal product used in the trial.įor clinical trials authorised via the combined review process you should prepare and submit using new part of Integrated Research Application System ( IRAS).įor clinical trials not approved or yet transitioned over to the combined review process, you should continue to use MHRA submissions. (c) the conduct or management of the trial, or (a) the safety or physical or mental integrity of the subjects of the trial, Changes count as a substantial amendment to your clinical trial authorisation if the amendment is likely to affect to a significant degree Only substantial amendments need to be submitted to the MHRA. Amending your trial protocol or other documentation We have published guidance on managing clinical trials during the COVID-19 outbreak, and on clinical trials applications for COVID-19. Clinical Trials and coronavirus (COVID-19)
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