Q. Is Pharmacy Assurance mandatory? How will it add value if it is not mandated?
A. Pharmacy Assurance is currently not mandatory. However, we do expect that applicants submit their studies for Pharmacy Assurance as we envisage that the quality of the information that will be provided by using it is high enough to be beneficial to sites when they come to conduct their capacity and capability assessments by reducing site-specific queries and cutting down on set-up times. This is because the Pharmacy Assurance process aims to provide one single technical review, rather than sites conducting their own individual technical reviews. Once the process has been fully rolled out, it will become a component of HRA and HCRW Approval.
Q: What indemnification does the HRA have in place for Pharmacy Assurance?
A. The HRA will indemnify reviewers for the completion of HRA-managed reviews, but not the payment aspect of the process. Indemnification of self-managed reviews should be provided by the reviewing trust/health board and/or reviewer (depending on local arrangements). The HRA will not indemnify any aspect of self-managed reviews.
Q. Does the HRA have a quality assurance programme in place for Pharmacy Assurance?
A. A quality assurance programme has been developed and put in place. This includes any issues raised being triaged to a suitable individual to ensure they are resolved appropriately, whether this is HRA staff, a reviewer, or the Four Nations Pharmacy Assurance Working Party. Feedback from applicants, reviewers and participating sites is also being monitored on a frequent basis. Further details about quality assurance and implications on payment can be found on our Review Fee page.
Q: What will happen to studies not eligible for review under this process at this time?
A. Sponsors and sites should continue to work to their current processes. We would strongly encourage sponsors to work closely with pharmacy experts to develop and clarify the information contained in the study documentation (e.g. protocols) and study applications, as this assists sites when conducting capacity and capability reviews and delivering the study. If a pharmacy manual is available or in development, we would recommend providing a copy of this for review by sites also, as this will help to keep queries to a minimum.
Q: Our organisation is part of a Joint Research Office (JRO), can we self-manage study reviews?
A. Yes, as long as part of your JRO arrangements covers sharing reviewers between the university and the trust.
Q: What are the expected timelines for a self-managed study?
A. Self-managed studies will be registered with the HRA before they can be sent for review, which should take no longer than five working days, excluding queries the technical assurance team may have with the applicant as part of the document check. Once the registration is completed, the timeline for the completion of the review process is entirely managed by the applicant.
Q: How do I know if a study we are participating in has Pharmacy Assurance?
A. It is currently the responsibility of the sponsor to confirm to sites whether a study has Pharmacy Assurance. If it does, the sponsor should provide participating sites with the completed technical review form. Additionally, the Initial Assessment Letter and HRA and HCRW Approval letter will include confirmation of whether a study has or is going through Pharmacy Assurance.
Q: Do we need to do anything different as a participating site if a study has Pharmacy Assurance?
A. You will still need to conduct your own capacity and capability reviews. However, a completed copy of the Pharmacy Technical Review Form should be included in the local information pack or sent directly from the sponsor and should be used to aid this process - you will not need to conduct your own pharmacy technical review. Pharmacists and pharmacy technicians at each NHS/HSC site will still be required to set up the study, ensuring completion of tasks such as preparation of the site files, receipt of and/or set up of trial stocks and the building trial prescriptions. Please note that this list is not exhaustive, and the trial pharmacists should ensure that all applicable tasks are complete prior to study commencement.