The Health Research Authority (HRA) has started accepting Phase III non-oncology CTIMPs taking place in secondary care in the NHS through Pharmacy Assurance from 30 September 2019. Phase I – III oncology studies taking place in secondary care in the NHS are also still being accepted.
To coincide with accepting additional study types, it is now expected that where the lead nation is England or Wales a submission will be made to the HRA for Pharmacy Assurance before the e-submission to the REC is completed. Relevant documents should continue to be emailed to firstname.lastname@example.org. It is recommended that sponsors submit studies for Pharmacy Assurance at least three weeks before they plan to e-submit to the REC.
The aim is to complete the Pharmacy Assurance review in time to be included in the local information pack. Earlier submissions to Pharmacy Assurance are therefore more likely to enable NHS/HSC sites to have the information they need to start their capacity and capability activities as soon as possible, leading to set-up activities taking place sooner or, where sites confirm they do not have capacity, sponsors being able to approach alternative sites more quickly. If the review is not completed by the time the local information pack is sent out, sites are continued to be advised to wait for the pharmacy technical review form to be sent to them before commencing any local pharmacy activities.
The next phase of Pharmacy Assurance roll-out will be to accept Phase I-II/III non-oncology CTIMPs taking place in secondary care in the NHS. This is likely to be in early 2020. Sponsors involved with these types of studies have been reminded they will start to be accepted next year and prepare accordingly, including ensuring they have appropriate funding to go through the process. Further announcements will be made in due course.
If you would like to give any feedback or speak to the HRA about Pharmacy Assurance, please contact the technical assurance team at email@example.com.