Pharmacy Assurance is going through a phased roll-out in England and Wales. We are now accepting all Phase I-III clinical trials of investigational medicinal products (CTIMPs) where the clinical specialism is oncology and Phase III CTIMPs in non-oncology specialisms where the following criteria are met:
- the trial is taking place in secondary care in the
- the lead NHS R&D office is in England or Wales
Other study types will be accepted in England and Wales at a later date.
All CTIMPs taking place in secondary care in the NHS will be processed through Pharmacy Assurance where the lead R&D office is in Scotland.
CTIMPs taking place in secondary care in the HSC where the lead R&D office is in Northern Ireland will be accepted at a later date.
How does the process work?
Pharmacy Assurance is a pre-submission review; it therefore takes place before e-submission to the REC. 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 if this has not been completed (see below)
- investigator’s brochure(s)
- summary of product characteristics
- investigational Medicinal Product (IMP) labels as sent to MHRA
- pharmacy manual (recommended)
- material safety data sheet(s) (recommended)
Submission of the IRAS form is not a mandatory requirements. However, if you choose not to submit the form, we would require the following in a covering email:
- IRAS ID
- study type selected at question 2 of the IRAS project filter page
- full study title
- short study title
- sponsor organisation as per question A64 of the IRAS form
- phase of CTIMP
- clinical specialism(s) listed in question A15 of the IRAS form
- confirmation of whether any investigational medicinal products (IMPs) are advanced therapy medicinal products (ATMPs) or radiopharmaceuticals as per Part B Section 1 question 15-3 of the IRAS form
- confirmation of the lead nation
- name of the lead NHS/HSC R&D office
We strongly recommend that any pharmacy manuals and/or material safety data sheets are submitted for review. While this is not a mandatory requirement, and the review can take place without these documents, it will help the reviewer when conducting the review and will reduce the likelihood of queries being sent by other sites when completing their own local reviews.
All documents should be provided to the Technical Assurance team via email.
You will also need to tell us which management route you would like your study to be processed through.
There are two management routes for Pharmacy Assurance:
This option is available to studies meeting the roll-out criteria where the lead nation is England or Wales, but not to single site studies. Alternative review arrangements are in place where the lead nation is Scotland.
Applicants also need to have funding to pay for the review. Our review fee page has further information about this.
Applicants submitting studies through the HRA-managed route have the option 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. In either instance, the entire review process will be managed by the HRA.
To support you with understanding the HRA-managed process, please refer to our process flow chart 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. It is also available to pre-funded studies and single site studies.
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 reviewing trust
- 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)).
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 in order to gain confirmation of Pharmacy Assurance. If you have reviewers that you prefer to use at your trust/health board 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.
We will register all self-managed applications and issue Pharmacy Assurance on behalf of all nations.
To support you with understanding the self-managed process please refer to our process flow chart below.
What will the timelines for review be?
At present, we cannot provide exact timescales for the review process as it is currently in 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 are collecting metrics in order to make a detailed assessment of the period of time Pharmacy Assurance takes.
Feedback that has been provided from both commercial and non-commercial sponsors has shown that the process is making a positive impact upon the speed and ease at which sites can begin setting up prior to the start of a study.
What happens after Pharmacy Assurance?
As Pharmacy Assurance provides 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 form to all participating sites as part of the Local Information Pack (LIP). Sites will use the information provided to assist them in their local capacity and capability assessments.
We recommend that the completed Pharmacy Technical Review Form is retained in the Pharmacy Site File.
Amendments to studies that have received Pharmacy Assurance are not supported. If the information contained within the Pharmacy Technical Review Form becomes outdated due to a change in the protocol or other supporting documents, please visit the guidance in the Maintaining Your Approvals section of IRAS Help.
Participating sites can find additional information within our Frequently Asked Questions. Alternatively, any queries that cannot be answered via our website can be directed to the technical assurances team via firstname.lastname@example.org.
How can I provide feedback?
welcome your feedback on the Pharmacy Assurance process and the guidance we
To provide feedback, or if you
have any questions about Pharmacy Assurance, please contact us at email@example.com.