Recommendations to improve safety reporting compliance so both regulator and sponsor can fulfil their obligations to protect patients
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.
Updated guidance is now available to assist trial sponsors in building resilience into new and ongoing trials during the continuing pandemic.
Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.
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.
MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.
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.
Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs
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.
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.
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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