There are two routes in which a review can be processed through Pharmacy Assurance or Radiation Assurance: HRA-managed or self-managed.
A standardised review fee is in place for studies which are processed through the HRA-managed route and where the reviewers are based in England, Northern Ireland or Wales. There is no standardised review fee where the self-managed route is used. Separate arrangements are in place in Scotland.
You can find out more about the HRA-managed and self-managed review routes for Pharmacy Assurance and Radiation Assurance on our dedicated pages.
Payments framework guidance
The payments framework guidance gives detailed information about the review fee for the technical assurances and how the payment should be managed, whilst a general overview about the fee and payment is given on this webpage.
The standardised review fee does not apply to self-managed studies, but if required, an agreement for an appropriate fee can be made between the reviewing trust or health board, and sponsor. We recommend that where the reviewing organisation providing a Radiation Assurance review through the self-managed route is not an organisation acting as a sponsor for the study, they are paid the standard review fee as a minimum.
When costing your study (for either budgeting purposes or grant applications), we strongly recommend that you include the standard review fee cost (£500 per reviewer). This is to ensure that you can still submit for technical assurance if you find out at a later date that you cannot go through the self-managed review route.
The standard review fee for new studies submitted through either technical assurance is £500 per reviewer. For Radiation Assurance only, if a change or amendment is submitted, a fee of £250 per reviewer is charged when the study already has Radiation Assurance. If the amendment is to add research exposures for the first time, it is treated as a new study and the full review fee will be applicable.
The above fees have been classified as a ‘Part A’ research cost and are exclusive of VAT. These costs are applicable where reviewers are based in England, Northern Ireland and Wales.
If sponsors do not have the funding to pay for the HRA-managed review, then they may be able to use the self-managed review route if they meet the eligibility criteria to do so; otherwise sponsors are expected to make alternative arrangements for review based on their current practice.
Payment on completion of the review should be made by the sponsor to the reviewing organisation, which is usually a trust or health board but for Radiation Assurance this could be a private organisation or individual reviewer. The HRA is not involved in the payment process – this is an agreement between the sponsor and reviewer or their employer. Reviewers are encouraged to speak to their finance department or ensure that appropriate systems are in place at their organisation to facilitate payment prior to any reviews being carried out.
Required number of reviewers per study
The number of reviewers you will need to complete your review will depend on the areas of expertise which your study covers and the availability of reviewers with specialist knowledge.
Whenever required we try to assign reviewers who cover more than one specialist area, but this isn’t always possible. We recommend that you seek funding for the maximum amount of reviewers you will need. The payments framework guidance gives further details on the specialisms of our reviewers to help you work this out.
Please note that for Radiation Assurance, the minimum review fee payable is £1000, as studies involving ionising radiation will always require review by at least one MPE and one CRE.
Service Level Agreement (SLA)
There is currently no template SLA available, but we are looking into the feasibility of producing one. In the meantime it is up to the sponsor and reviewing organisation to agree the most appropriate form of agreement for completion of the review and payment.
Payment for quality assurance checks
There is no separate payment for this activity. Quality assurance checks of reviews will be funded by the review fee paid by the sponsor to the trust/health board. Further details about payment and quality assurance can be found in our payments framework guidance.