MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.
Deputy Unit Manager/Senior Medical Assessor, CTU
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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Comments and moderation
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- A Practical example of applying Quality Risk Management in GDP – Transportation Risks