In parts one and two of this series, we looked at how we responded to the unprecedented challenges the COVID-19 pandemic and the lessons we have learned. In this final part, we explore the challenges ahead. Remote access to EHRs …
Deputy Unit Manager/Senior Medical Assessor, CTU
In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the set-up and approval of clinical trials. Now we look at the unprecedented challenges we faced in …
The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and how we move forward to implement those learnings for the benefit of the UK …
MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.
Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs
All early phase clinical trials have risks associated with them that require mitigation. Following not just the legislation but also all the associated guidance will help in maintaining public safety and the credibility of data.
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About the MHRA Inspectorate Blog
This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.
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- Compliance Monitor Process (Part 2)– CM role and application process
- Compliance Monitor process (Part 1) – An introduction
- MHRA Good Practice Symposia Week (7 to 11 March 2022)
- Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward
- Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned