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Forum: Good Clinical Practice (GCP) - forums.mhra.gov.uk
Apr 23, 2020 · Threads 1 to 30 of 48. Good Clinical Practice (GCP) The GCP forum has been created as a tool to help those involved in clinical trials of Investigational Medicinal Products to comply with the clinical trials legislation and GCP requirements. It provides the ideal opportunity for extended communication between researchers and allows users to put
Forums.mhra.gov.ukMHRA produced FAQs for Risk Adaptive Approach
Mar 29, 2012 · The mhra have implemented a dual strategy for a risk-adapted approach for clinical trials in the UK. The first is a stratification approach into type A, B or C dependent upon the use of the investigational medicinal product (IMP) in relation to its marketing authorisation or an unlicensed IMP, i.e. the risks associated with the IMP.
Forums.mhra.gov.ukExamples of risk assessments - Medicines and Healthcare …
Mar 5, 2013 · The mhra GCP Inspectorate set up a collaborative group to produce FAQs and produce example documentation relating to the risk adaptive approach. The risk assessments are not intended to be definitive templates or tools, but are provided as examples of what risk assessments may look like and organisations may use the examples to help develop their own …
Forums.mhra.gov.ukViolations and deviations - definition - Medicines and Healthcare
Sep 1, 2012 · A: protocol deviation is any change, divergence, or departure from the study design or procedures defined in the protocol. Important protocol deviations are a subset of protocol deviations that may significantly impact the completeness, accuracy, and/or reliability of the study data or that may significantly affect a subject's rights, safety
Forums.mhra.gov.ukCalibration certificates - Medicines and Healthcare products …
Aug 28, 2012 · Calibration certificates. We are an acute hospital Trust and as such, equipment utilised for clinical trial patients in the main (weighing scales, BP monitors , infusion pumps etc etc ) is not separate from patients receiving treatment outside the clinical trial setting. Although there are contracts in place to service, maintain and calibrate
Forums.mhra.gov.ukMHRA produced FAQs for Risk Adaptive Approach - Page 2
Mar 29, 2012 · The mhra does not normally advise on the IMP risk stratification or on the eligibility of individual clinical trials for the notification scheme prior to an application being made by a sponsor. Example risk assessments will be reviewed by the mhra GCP Inspectorate and published on the GCP Forum to assist sponsors in developing their risk assessment processes.
Forums.mhra.gov.ukMHRA Forums - Medicines and Healthcare products Regulatory …
Oct 29, 2024 · The mhra Blood forum has been created as a tool to help those involved in blood component collection, processing, testing and distribution to comply with the EU Blood Directives, UK Statutory Instruments and good practice requirements. It provides the ideal opportunity for extended communication between peers and allows users to put forward
Forums.mhra.gov.ukMHRA produced FAQs for monitoring - Page 2
Feb 22, 2013 · The mhra GCP Inspectorate believes that ICH GCP b underestimates the role that central monitoring can take as it states that monitoring without on-site visits should only be in “exceptional circumstances”. If the risk assessment undertaken has not identified the need for on-site visits to mitigate vulnerabilities and assure that the trial would be undertaken to the …
Forums.mhra.gov.ukMHRA produced FAQs for Investigational Medicinal Product (IMP)
Oct 25, 2011 · 1. Where can I find further information on this subject? The following FAQs are presented below: 2. What is an investigational medicinal product (IMP)?
Forums.mhra.gov.ukForum: Blood Forum - Medicines and Healthcare products …
Dec 21, 2021 · Forum Rules. The mhra Blood forum has been created as a tool to help those involved in blood component collection, processing, testing and distribution to comply with the EU Blood Directives, UK Statutory Instruments and good practice requirements. It provides the ideal opportunity for extended communication between peers and allows users to
Forums.mhra.gov.uk