Technical Assurance is a pre-submission review process that we offer for studies that involve pharmacy (CTIMPs) or ionising radiation (which includes things like x-rays and radiotherapy).
We offer two types of Technical Assurances – Pharmacy Assurance and Radiation Assurance.
These assurance processes can be either self-managed or managed by the HRA – that is, either the HRA can arrange for the reviews to happen by the appropriate expert, or researcher can arrange this themselves.
As part of the process the study applications are reviewed by independent experts who provide key technical information to regulatory bodies and sites, to support study set up. This may involve a review fee.
Once the assurance process has been completed the Health Research Authority will confirm the Technical Assurance is in place and the study can be submitted for review by a Research Ethics Committee.
Sites where research is planned to take place can use these UK-wide assurances to support them to participate.
The standardised format has removed some variation and duplication from the application process, speeding up site set up in the NHS.
Radiation Assurance
Radiation Assurance is a UK-wide process managed by the Health Research Authority on behalf of all four UK nations for studies which are taking place in NHS and Health and Social Care in Northern Ireland (HSC) secondary care settings.
The process ensures that the information regarding radiation exposures in study documents are clearly set out at an early stage in the research regulatory approvals pathway.
Radiation Assurance can be either managed by the HRA, or self-managed by the applicant.
Our aim is to provide Radiation Assurance, for studies that the HRA manages, within 40 days of receiving a submission.
Between 2018 and 2023 we have seen a large rise in the number of Radiation Assurances we have provided, rising from 20 in 2018, to a peak of 209 in 2022. This rise is linked to an expansion in the study types that we offer Radiation Assurance for.
This rise in numbers is reflected in the time taken for Radiation Assurance to be provided. Between 2018 and 2021 the median number of days taken for assurance to be provided was well below our 40 day target.
However, in 2022 our the median number of days taken for assurance to be provided was 53 days. This can be attributed to the record number of assurances provided in 2022 and lack of availability of expert reviewers.
In 2023 we provided fewer Radiation Assurances (197) and accordingly saw the median number of days taken to provide assurance fall from 53 days in the previous year to 45 days, slightly above our 40 day target.
This data covers HRA managed Radiation Assurance only as we do not report on self-managed studies.
Latest review times
Between January 2024 and March 2024 (quarter four 2023/24) the median number of days for Radiation Assurance to be provided was 57 days.
Between April 2024 and June 2024 (quarter one 2024/25) the median number of days for Radiation Assurance to be provided was 47 days.
Quarterly breakdown of review times
Below you can see a quarterly (every three months) break down of review times for 2018 to 2023:
Pharmacy Assurance
Pharmacy Assurance is a process managed by the Health Research Authority for Phase 1-III clinical trials of investigational medicinal products (CTIMPS) that happen at more than one site in the NHS.
Studies are eligible for submission when the trial is taking place at multiple secondary care sites in the NHS or the lead NHS research and development office is in England or Wales.
The process is UK wide collaboration, but the submission process varies depending on the location of the lead nation for the study.
Pharmacy Assurance is a key component of HRA and HCRW Approval. The process can be either managed by the HRA, or self-managed by the applicant.
Our aim is to provide Pharmacy Assurance, for studies that the HRA manages, within 30 days of receiving a submission.
Pharmacy Assurance was launched, in December 2018. Between 2019 and 2023 we have seen a large rise in the number of Pharmacy Assurances we have provided, rising from 7 in 2019 to a high of 142 in 2023.
This data covers HRA managed Pharmacy Assurance only as we do not report on self-managed studies.
The rise in the number of submissions for Pharmacy Assurance between 2019 and 2023 initially led to an increase in the time taken to provide assurance. In 2020 the median number of days taken for assurance to be provided was 36 days, above our 30 day target.
However, since 2020 the time taken for review has improved, dropping to 30 days in 2021, 26 days in 2022 and 27 days in 2023.
Latest review times
Between January 2024 and March 2024 (quarter four 2023/24) the median number of days for Pharmacy Assurance to be provided was 27 days.
Between April 2024 and June 2024 (quarter one 2024/25) the median number of days for Pharmacy Assurance to be provided was 27 days.
Quarterly breakdown of review times
Below you can see a quarterly (every three months) break down of review times for 2018 to 2023: