As Pharmacy Assurance provided the review that sites would normally conduct as part of set up, the next step is for the sponsor to provide a copy of the completed pharmacy technical review for to all participating sites as part of the Local Information Pack (LIP). Sites will use this information in their local capacity and capability assessments, with the aim of speeding up set-up time and allowing sites to start recruitment as soon as possible.
Following set up at site, we recommend that the completed pharmacy technical review form is retained in the Pharmacy Site File for future reference.
We don't support amendments to studies that have received Pharmacy Assurance. If the information in the pharmacy technical review form becomes outdated due to a change in the protocol or other supporting documents, we recommend sponsors completed the pharmacy assurance amendment site notification form and send this to sites to support their ongoing management of the study. There is more information in the Maintaining Your Approvals section of IRAS Help.
Participating sites can find additional information within our Frequently Asked Questions, or you can contact the technical assurances team at pharmacy.assurance@hra.nhs.uk.
Sponsors and sites can also contact the technical assurances team to provide feedback on the Pharmacy Assurance process and the guidance we have provided.