From Wednesday 30 September 2020, the HRA will accept Phase I and II non-oncology CTIMPs through the Pharmacy Assurance process. This means that from this date, all eligible Phase I-III CTIMPS taking place in secondary care in the NHS can be processed through Pharmacy Assurance.
As a reminder to all NHS sponsors, the HRA now expects that where the lead nation is England or Wales, a submission will be made to the HRA for Pharmacy Assurance before the submission to the REC. Please email relevant documents to pharmacy.assurance@hra.nhs.uk.
We recommend that sponsors submit studies for Pharmacy Assurance at least three weeks before they plan to submit to the REC. This will make sure that receipt of Pharmacy Assurance is given before or at the same time as the Initial Assessment Letter. You can read more about the benefits of this on our Pharmacy Assurance webpages.
For sponsors who plan to apply for review through the self-managed route, please make sure you have HRA registered reviewers at site and the appropriate funding to go through the process.
We also continue to welcome and accept applications from all sponsors (NHS and non-NHS) who have eligible studies to submit. Further information is available on the HRA website.
We continue to have reciprocal arrangements with colleagues in Northern Ireland and Scotland – where either of these countries are the lead nation, all CTIMPs are processed through Pharmacy Assurance or the Coordinated Pharmacy Review process respectively.
If you have any queries about Pharmacy Assurance please email us at pharmacy.assurance@hra.nhs.uk.