WebIntegrated Research Application System (IRAS) This is the UK electronic gateway for researchers. When they wish REC review they must complete the appropriate sections of “IRAS” and submit it electronically. The central document the REC receives is the Ethics Committee application form, extracted from IRAS. WebAmendments A new UK amendment process will be implemented across the 4 UK nations on 2 June 2024, this includes online submission of amendments and a new amendment tool. These new processes for handling amendments are part of our ongoing programme to improve services for applicants.
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WebDec 31, 2024 · Amendments relevant to the Research Ethics Committee (REC) The Health Research Authority ( HRA) has produced guidance on when amendments are required to be submitted for REC review. Northern... WebNov 28, 2024 · Up to two amendments can be made to a study without submitting a revised SoECAT, as long as the changes have no impact on ETCs, but upon a third amendment, excluding amendments to add sites/PICs, a revised and re-authorised SoECAT should be submitted to ensure that the SoECATs maintain alignment with the study. how is a theremin built
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WebDec 18, 2014 · The Medical Devices (Fees Amendment) Regulations 2024 came into force on 1 April 2024. These regulations include the introduction of new fees for amendments to clinical investigations. You do not... WebDec 6, 2024 · IRAS amendment tool updated to new version 6th December 2024 From Monday 6 December 2024, the amendment tool will indicate that substantial changes to … WebWhen a trial is temporarily halted, the MHRA and the reviewing ethics committee must be informed within 15 days. The notification should be made as a substantial amendment using the notification of amendment form, clearly explaining what has been stopped and the reasons for the suspension. high kvp does to an electron tube