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HRA Now - new pharmacy set-up pilot opening
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What: together with the Experimental Cancer Medicine Centres (ECMC) network the HRA is launching a pilot to test improving the existing Pharmacy Technical Assurance process with newly developed pharmacy set-up guidance
Who: commercial and non-commercial sponsors, Clinical Research Organisations and Clinical Trials Units, research and development offices and pharmacy departments at ECMC sites
When: from Monday 2 June 2025
Where: research carried out at ECMC sites in England, Northern Ireland, Scotland and Wales
We are looking for sponsors to take part in a new pilot designed to test a streamlined study set-up pathway and mandated UK-wide Pharmacy Technical Assurance process within early-phase oncology trials via the ECMC network.
The pilot aims to remove unnecessary duplication and support sponsors to provide the right information, to the right people, at the right time, to enable sites to focus on the parts of set-up that only they can do.
This will include testing a new framework of additional guidance and support, to help sponsors and sites work together in a consistent way.
What does the pilot involve?
Sponsors who agree to take part in the pilot will be expected to:
- use the newly developed guidance when they select and set-up sites
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submit their study for Pharmacy Technical Assurance
- attend an online training session about the guidance and support available for the pilot - for sponsors who have not used Pharmacy Technical Assurance before, additional training is available
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provide feedback on the pilot and guidance
All ECMC centres will be expected to:
- have at least one trained technical reviewer available during the pilot
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attend an online training session and support events
- use the information provided in the Pharmacy Technical Assurance review form to start set-up
- be ready to set-up studies that come through the pilot, as set out in the guidance
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provide feedback on the pilot and guidance
Take part in the pilot
Sponsors who are interested in taking part in the pilot and would like to receive a copy of the draft guidance can express an interest by emailing pilot.testing@hra.nhs.uk referencing 'pharmacy set-up pilot' in the email subject.
We are also offering training on the new guidance, as well as an introduction to the Pharmacy Technical Assurance process and details on how to become a Lead Pharmacy Reviewer.
UK Clinical Research Delivery programme
This pilot forms part of our work on the UK Clinical Research Delivery (UKCRD) programme.
It is part of a workstream which is committed to reducing unnecessary duplication of our study-wide reviews for information governance and improving the effectiveness and consistency of Technical Assurances.
You can read more about our work as part of the programme on the HRA website.
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HRA Now brings you important operational updates from the HRA - including changes to guidance or processes which might affect you. |
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