The HRA is rolling out the next phase of Pharmacy Assurance in England and Wales from Monday 30 September 2019.
From this date we will accept all phase III non-oncology CTIMPs taking place in secondary care in the NHS. We will continue to accept secondary care oncology phase I-III CTIMPs.
Based on feedback, some changes are being made to the process and our submissions guidance ready for the roll-out of the next phase. These include:
- A change to the timing of submission. Applications will need to be submitted prior to an application being made to a REC and we recommend that a submission to Pharmacy Assurance is made no later than three weeks before e-submission of the IRAS form. This is so that we can complete the review in time for participating sites to receive the completed review at a point which is most useful to them.
- Guidance for applicants about what pharmacy aspects of the study the review covers. Applicants can check whether they need to submit all information the reviewers will need initially, or whether they may need to provide further information during the review on some additional areas. We hope this means that applicants can better prepare themselves.
An overview of the benefits of the review process can be found on our Pharmacy Assurance page. Detailed submissions guidance can be found on IRAS.
To support this roll-out, we’re continuing to welcome and accept applications from those with the appropriate expertise in reviewing clinical trials to become Pharmacy Assurance registered reviewers. We’re particularly interested in receiving applications from radiopharmacists or radiopharmaceutical scientists, but encourage any interested pharmacists and pharmacy technicians - especially those with experience in non-oncology trials - to apply.
Further information is available here and you’re welcome to contact the Technical Assurance team for a chat. The deadline for applications is Friday 13 September.