What is it?
The HRA Pharmacy Assurance process coordinates a single technical pharmacy review for eligible studies, which can be used by all participating study sites, rather than all sites conducting their own technical pharmacy review. The completed review provides assurance to study sites that they have all of the information available to assess local capacity and capability and ensure that the study is deliverable locally.
This reduces duplication in the pharmacy review of new studies, helping to shorten study set up times. You can see what information Reviewers will be looking at in our Documents section.
Pharmacy Assurance will be a component of HRA Approval once a phased implementation is completed. Until then, Pharmacy Assurance will remain a separate process.
What studies are currently accepted?
The HRA is currently accepting studies meeting all the following criteria for review through the Pharmacy Assurance procedure:
- Clinical Trials of an Investigational Medicinal Product (CTIMPs) involving a Phase I and/or II aspect;
- The disease being studied is cancer;
- The lead site is part of the Experimental Cancer Medicine Centre (ECMC) network;
- Does not involve a radiopharmaceutical.
If your study meets these criteria and if local pharmacy set up reviews have not already started at sites, please contact the Technical Assurances Officers at email@example.com to submit.
How does the process work?
When a study is submitted for Pharmacy Assurance, the Technical Assurances Officers will check that they have all of the documents they need. These are:
- Integrated Research Application System (IRAS) form;
- Investigator’s Brochure(s) (where applicable);
- Summary of Product Characteristics (where applicable);
- Pharmacy Manual (where applicable and available);
- Material Safety Data Sheet(s) (where applicable);
- Investigational Medicinal Product (IMP) Labels.
If any of the above documents have already been submitted to the HRA through IRAS, they can be accessed by the Technical Assurances team. You will need to email any documents which have not already been submitted to the HRA. We strongly recommend that any Pharmacy Manuals and/or Material Safety Data Sheets are submitted for review. This is not a mandatory requirement but 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.
What are the benefits of the process?
Pharmacy Assurance is designed to deliver the following benefits:
- Give greater clarity to study teams at the outset about the information requirements for sites to review and set up studies.
- Release staff time currently spent on completing parallel reviews and raising similar queries at multiple sites.
- Give Reviewers the authority to provide useful feedback and, if necessary, to challenge the study team at an early point of the site set up process.
- Reduce the number of queries which sponsors receive from pharmacy departments, enabling them to concentrate on resolving local issues.
- By achieving the above, we will streamline the local pharmacy capacity and capability assessments.
Is there a charge for review?
There is currently no charge for a new study to be reviewed through Pharmacy Assurance. Please note that in future there will be a charge for conducting a review – see ‘Is there a payment involved?’
- Publication of our Payments Frameworks Guidance for funders, sponsors and sites.
- Securing continuing Pharmacy Expert involvement for ongoing developments and improvements to the process
- Recruitment of additional Pharmacy Reviewers.
- Opening to other study types – the next studies to be accepted will be all Phase I, II and II/III CTIMPs.
Contact us at firstname.lastname@example.org