From the autumn we will extend pharmacy assurance to accept more study types in secondary care. Currently, we accept oncology trials phase I-III and non-oncology phase III. We will be extending this to accept all non-oncology phase I-III.
Trial type | Phase 1 | Phase 2 | Phase 3 | Phase 4 |
Oncology | Yes | Yes | Yes | No |
Non-oncology | Yes | Yes | Yes | No |
We expect NHS sponsors in England and Wales to submit all eligible trials through pharmacy assurance. All other sponsors are encouraged to consider using pharmacy assurance. Feedback from NHS pharmacists is that pharmacy assurance makes it easier for them to support swift site set-up and reduces the burden on them of duplicate checks at each site. Sponsors tell us that pharmacy assurance reduces delays in study set-up and reduces queries from individual pharmacy departments.
Further information is available on the HRA website, with full submissions guidance available on the IRAS website.
We also continue to welcome and accept applications from those with the appropriate expertise in reviewing clinical trials to become Pharmacy Assurance registered reviewers. Detailed guidance on how to apply is available on our website.
If you any queries about Pharmacy Assurance please contact us at pharmacy.assurance@hra.nhs.uk.