mhra substantial amendment examples
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non substantial amendment example
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Dec 18, 2014 These changes count as a substantial amendment to your clinical trial authorisation. covering letter outlining the substantial and any non-substantial changes; signed Please view MHRA clinical trials guidelines here. The decisions on whether an amendment is substantial or non-substantial should be made by the sponsor. The system also provides guidance on substantial amendments and their submission. In addition, submission to the MHRA can be made using the Common European Submission Platform (CESP). A non-substantial amendment is a change to the conduct of the clinical trial that does outline responsibilities (define task and roles) and provide guidance on a May 25, 2018 Notifying amendments to MHRA Medicines Notification is not required for amendments not meeting the criteria for substantial amendments. For further guidance about notifying substantial amendments to RECs and May 24, 2018 Examples of substantial amendments: changes to the design or methodology of the study, or to background information likely to have a Jul 25, 2014 See Volume 2C, “Regulatory Guideline” of the European Commission's Notice to Notification to MHRA of non-substantial amendments.These safety measures, such as temporarily halting the trial, may be taken without prior authorisation from the MHRA but must be reported to the MHRA and Ethics Committee. For all other substantial amendments, MHRA authorisation must be sought before the amendment is implemented. Oct 14, 2011 MHRA produced FAQs for Regulatory Documents (inc protocol, CSRs & publications) Non-substantial amendments to protocols do not need to be submitted to the Further guidance is available here: Managing your CTA. Aug 9, 2018 To help you with this categorisation, we have provided examples of substantial and non-substantial amendments. If you are seeking guidance Notification is not required for amendments not meeting the criteria for For guidance on submission of substantial amendments to the MHRA, please see.