Pharmacy Assurance is an integral part of study set-up in the NHS and HSC. We currently accept all Phase I-III clinical trials of investigational medicinal products (CTIMPs) when:
- the trial is taking place at multiple secondary care sites in the NHS and;
- the lead NHS R&D office is in England or Wales
It is expected that NHS sponsors in England and Wales submit their eligible studies through the process from 1 April 2020. The process will continue to be available for other sponsors with eligible studies.
Other study types will be accepted in England and Wales at a later date.
Please note that single site studies will not be accepted in England and Wales.
Information about applying for Pharmacy Assurance in Scotland and Northern Ireland is available on the IRAS website.
How does the process work?
Pharmacy Assurance is a pre-submission review which takes place before e-submission to the REC. This is to ensure that information is available to sites in good time to conduct their capacity and capability review. We recommend that studies should be submitted for Pharmacy Assurance no later than three weeks prior to submission for HRA and HCRW Approval.
When a study is submitted for Pharmacy Assurance, we will check it has all of the required documents. These are:
- either the draft Integrated Research Application System (IRAS) Form or selected information from the form in a covering email (see below)
- investigator’s brochure(s)
- summary of product characteristics
- investigational medicinal product (IMP) labels as sent to the Medicines and Healthcare products Regulatory Authority (MHRA)
- pharmacy manual (recommended)
- material safety data sheet(s) (recommended)
If you do not submit the IRAS Form, a covering e-mail should include:
- IRAS ID
- study type (selected at question 2 of the IRAS project filter page)
- full study title
- short study title
- sponsor organisation (from question A64 of the IRAS form)
- phase of CTIMP
- clinical specialism(s) (from question A15 of the IRAS form)
- confirmation of whether any investigational medicinal products (IMPs) are advanced therapy medicinal products (ATMPs) or radiopharmaceuticals (from Part B Section 1 question 15-3 of the IRAS form)
- confirmation of the lead nation
- confirmation of which UK nations are planned to participate in the trial
- name of the lead NHS R&D office
- number of UK sites in the study (from question A71-2 of the IRAS form)
- total UK sample size (from question A59 of the IRAS form)
- confirmation of whether the study will involve primary care (from question A72 of the IRAS form)
We strongly recommend that any pharmacy manuals and/or material safety data sheets should be submitted for review. The review can take place without these documents but sending them now will reduce the likelihood of queries.
Where a pharmacy manual will not be available we recommend reviewing the exemplar pharmacy technical review form to see what detail will be required.
All documents should be provided to the Technical Assurance team via email to email@example.com.
You will also need to tell us how you would like your study to be processed.
There are two management routes for Pharmacy Assurance:
Both options are available to studies meeting the roll-out criteria where the lead nation is England or Wales.
This process is managed by the HRA on behalf of the applicant and involves a review fee payable to the reviewing trust; our review fee page has further information. The HRA-managed option is not available to single site studies.
Applicants submitting studies through the HRA-managed route have the choice to request up to three trusts or health boards for the HRA to approach to undertake the review. Alternatively, we will select HRA registered reviewers with the appropriate experience in the study field, such as paediatric oncology.
There is a process flow chart for the HRA-managed route below.
This option is available to non-commercial studies where the sponsor (or co-sponsor) is the same as the reviewing trust or health board.
Applicants submitting studies through the self-managed route will manage the selection of reviewers and the review process. Reviewers undertaking the review on behalf of the applicant should meet the following criteria:
- be registered with the HRA
- be based at the sponsoring trust/health board
- had input into the development of the study documents and set up of the study (in particular the sourcing, packaging, and labelling of IMP(s)).
You are expected to specify which reviewer(s) have been selected when registering your application for self-managed review. You will need to send your completed review to us for confirmation of Pharmacy Assurance. If you have reviewers that you prefer to use at your trust/health board but who are not currently registered with us, please encourage them to register as reviewers with us. More information is available on our reviewer registration page.
There is a process flow chart for the self-managed process below.
What will the timelines for review be?
During the roll out phase we are testing a timeline for HRA-managed studies of 30 calendar days. As studies come in and are reviewed, we collect data about the actual time taken for Pharmacy Assurance and may adjust timelines in the future.
For current metrics please see our main Pharmacy Assurance page.
Feedback from both commercial and non-commercial sponsors has shown that the process makes site set up quicker and easier prior to the start of a study.
Still got questions?
Visit our FAQs page.