WebbSubstantial Amendment Notification Form. NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN … Webb24 okt. 2024 · A sponsor may make an amendment to a clinical trial authorisation, other than a substantial amendment, at any time and without the need for licensing …
Combined review - Health Research Authority
Webb2 maj 2013 · The Clinical Trial Regulations (UK SI 2004/1031, as amended) refers to the process of informed consent in parts 3(1), 4(1) and 5(1) of Schedule 1. The text in each part of the schedule states: "...has had an interview with the investigator, or another member of the investigating team, in which he has been given the opportunity to … Webb3 feb. 2024 · Firstly, MHRA Clinical Trials would need to be informed via a variation to the CTA. Extension of shelf life represents a substantial amendment, unless you have … little einsteins castilian spanish slow
We’ve updated our amendment tool on IRAS
WebbAttached is the HRA and HCRW Approval together with the amendment package, including the amendment tool. Please read the documents and amendment tool … Webb21 mars 2024 · Medicines and Healthcare products Regulatory Agency Published 21 March 2024 A series of new measures will be introduced by the Medicines and … Webb3 dec. 2024 · You can access the amendment tool on IRAS. Since 2 June 2024, all applicants who make an amendment to project-based research need to complete the … little einsteins boys are back