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IB or SmPC changes that do not alter the RSI and have no impact on Risk/Benefit do not need to be submitted to the MHRA as substantial amendments. Sponsors should be aware that any change to the RSI is a change to the Risk/Benefit and requires that a substantial amendment be submitted to the MHRA and approved before it is implemented in the trial.
An investigational medicinal product is any medicinal product which is being tested within a trial or any product, including placebo, used as a reference in a clinical trial. This includes products with a marketing authorisation where the product is: used in a different form from the marketing authorisation. used for an indication not included ...
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 ...
Nov 4, 2011 · It is not clear why core essential records need to be retained for 15 years or approval/discontinuation plus 2 years whereas all other records pertaining to the trial need to be kept for as long as the product is marketed. One interpretation is that the first (shorter) requirement applies to the investigator site file only, since the text ...
Dec 1, 2016 · Reviewing for any change to SPCs. As an academic sponsor we have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs. We have put together a tracker which holds all of the IMPs, each month we search the MHRA website to see if the SPC for each IMP has been updated. As the MHRA website does not include a ...
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 risk assessment processes.
Jun 8, 2018 · Forum. Good Clinical Practice (GCP) Computer system validation (CSV) and IT systems. You will need to register or login above with your username to post on this forum. If you require further help please view our quick start guide or view the online help section. Threads 1 to 17 of 17. Forum: Computer system validation (CSV) and IT systems.
Oct 25, 2011 · The Institute of Clinical Research and the Royal Pharmaceutical Society of Great Britain has produced guidance on this topic, which states that, ‘When a clinical trial is taking place in a hospital all IMPs should be stored and issued by the hospital pharmacy and managed to the same standards as licensed medicines.
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.
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 ...
