NHS Research and Development (R&D) staff and pharmacy staff from across England and Wales have been taking part in workshops with us to prepare for implementing pharmacy assurance for NHS sponsored studies.
We recently announced that from 1 April 2020 we will expect NHS sponsors in England and Wales to submit their eligible studies through Pharmacy Assurance. To help sponsors, NHS R&D departments and pharmacy clinical trials staff to prepare for this, we have been running a series of workshops to explain the process, how it can benefit them and what they need to do now.
Pharmacy Assurance helps streamline study set-up. It’s based on the pharmacy technical review happening once, with all NHS sites using the outcome. NHS pharmacists complete the single technical review, following UK-wide standards, as part of the sponsor study preparation. We want NHS sponsors in England and Wales to adopt this process from April for all Phase I-III oncology and all Phase III non-oncology Clinical Trials of Investigational Medicinal Products (CTIMPs).
The six workshops, held across England, have had a really positive response from delegates at all of the sessions, with particularly good feedback from pharmacists and technicians who are eagerly awaiting completed Pharmacy Assurance reviews. There have been some very interesting questions and helpful discussions during the workshops, with everyone telling us that they know more about Pharmacy Assurance after the session than they did before it. It’s also been great to hear that everyone has felt able to take the information they’ve learned and use it at their sites to implement Pharmacy Assurance.
We have been recording the questions people have been asking and the comments they have raised so that once all the workshops are completed we can see if there is any more work we can do to provide guidance, support sponsors and sites, or tweak our processes so that everyone can make the most of Pharmacy Assurance. Some positive things which have already been identified during the workshops are things that we can quickly change, while others will take longer to do.
Don’t forget that Pharmacy Assurance is still open to non-NHS sponsors who have eligible studies to submit. General information is available on the HRA website, with full submissions guidance available on the IRAS website.
If you any queries about Pharmacy Assurance please contact us at pharmacy.assurance@hra.nhs.uk.