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Q. Do I have to use Pharmacy Assurance?

A. Pharmacy Assurance is not mandatory, but we expect that NHS sponsors use the process as it has been shown that the quality of information resulting from the review is beneficial to sites when conducting their capacity and capability assessments. It also reduces site-specific queries and cuts down on set-up times. The Pharmacy Assurance process ensures that high level information spread across trial documents is summarised in one form that sites can refer to easily, and provides a 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. When should I submit to Pharmacy Assurance?

A. Pharmacy Assurance needs to be completed before applying for other regulatory approvals such as Research Ethics Committee (REC) review and HRA and HCRW Approval. We advise applicants to submit their application no later than three weeks before the intended submission date to the REC. This allows enough time for the review to take place and to ensure changes are not required prior to HRA and HCRW Approval.

Q. How do I apply/submit to Pharmacy Assurance?

A. Documents should be submitted to pharmacy.assurance@hra.nhs.uk. Full submission guidance is available on our IRAS help page. A summary of the application process is available on our Applying for Pharmacy Assurance page.

Q. How much is the fee for Pharmacy Assurance?

A. Please see our Review Fee page for further details on funding and payment. Funders should ensure that the review fee has been included in the costing template as a Part A research cost (exclusive of VAT).

Q. Does the HRA indemnify Pharmacy Assurance?

A. The HRA indemnifies reviewers for HRA-managed reviews, but not the payment aspect of the process. Self-managed reviews should be indemnified by the reviewing trust/health board and/or reviewer (depending on local arrangements).

Q. Does the HRA have a quality assurance programme in place for Pharmacy Assurance?

A. A quality assurance programme is in place for Pharmacy Assurance. 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 Pharmacy Assurance at this time?

A. All Phase I – III oncology and all Phase III non-oncology multi-centre studies taking place in the NHS are eligible for submission to Pharmacy Assurance in England and Wales. For all other study types, sponsors and sites should continue to work to their current processes. We 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, as this will help to keep queries to a minimum.

Q. What are the overall timelines for an HRA-managed study to be processed through HRA Pharmacy Assurance?

A. We are working to a timeline of no more than 30 calendar days to complete the pharmacy technical review, exclusive of time taken for queries. We continue to collect data to establish how long it takes for a study to be processed through HRA Pharmacy Assurance as an HRA-managed study. For details on current metrics please see our main Pharmacy Assurance page.

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. This process 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 received Pharmacy Assurance?

A. The sponsor should provide a copy of the pharmacy technical review form in the Local Information Pack, which you can use as part of your own capacity and capability reviews. 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 of trial prescriptions. Please note that this list is not exhaustive, and trial pharmacists should ensure that all applicable tasks are complete prior to study commencement.

Q. Will amendments be reviewed as part of Pharmacy Assurance?

A. No. Should the information contained within the technical pharmacy review form become outdated, please follow guidance on how to notify participating NHS/HSC sites on the IRAS website.

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