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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How investigators and sponsors should manage clinical trials during COVID-19
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Actions that trial sponsors should consider to build resilience into clinical trial design
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
A complete list of 5G projects involved in the 5G Testbeds and Trials Programme
Protocols and procedures for testing the value for cultivation or use (VCU) of agricultural crops.
Details of dates when trials are likely to take place at the Chancery division of the High Court.
What you need to provide to the Environment Agency if you want them to consider allowing your proposed research or trial.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
Get help if you're a victim or witness who needs to give evidence in court. Find out how to review your statement, protection you can get in court and how to claim expenses.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
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