MHRA Guidance on Coronavirus
Following on from our previous post, further guidance has been published on our MHRA website in relation to Managing Clinical Trials and Clinical Trial Applications.
Gail Francis
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held various positions in monitoring, Project Management, and more recently in GCP Compliance and Training Management. Gail was promoted to Senior Inspector in October 2005 and accredited to perform Pharmacovigilance Inspections in November 2007. In June 2010 Gail was promoted to Expert Inspector, GCP.
Advice for Management of Clinical trials in relation to Coronavirus
Posted by:
Gail Francis and Kirsty Wydenbach, Posted on:
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Categories:
Compliance matters, Good clinical practice
MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.
Round Table: The impact of Electronic Health Records on UK Clinical Trials
Posted by:
Paula Walker, Gail Francis and Jennifer Martin, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice
On 28 October 2019 the GCP inspectorate will be holding a roundtable discussion aimed at suppliers of electronic health records in both primary and secondary care (including commercial and non-commercial developers). This post details how to register your attendance for this event.
How to manage safety reporting in a blinded trial
Posted by:
Gail Francis and Kirsty Wydenbach, Posted on:
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Categories:
Compliance matters, Good clinical practice
Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs
Short format Development Safety Update Report (DSUR) for Type A trials
Posted by:
Gail Francis and Rosalind Polley, Posted on:
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Categories:
Compliance matters, Good clinical practice
Not all trials are the same in terms of risk. To support UK sponsors of clinical trials, a substantially simpler and shorter form may be submitted in lieu of a full DSUR, giving a significant time saving.
Upcoming GCP stakeholder engagement meeting
The MHRA are holding a GCP Stakeholder engagement meeting on 16th November at our offices in London in order to explore 3 areas of the new Clinical Trials Regulation that require national legislation.
Inspecting clinical trials - The trial master file
The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights …
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