Context
As part of UK wide work to streamline research, a HRA Radiation Assurance process for studies involving ionising radiation has been tested and is being rolled out across the UK. The process coordinates and standardises the Medical Physics Expert (MPE) and Clinical Radiation Expert (CRE) review using an agreed methodology, before studies are submitted for Research Ethics Committee (REC) review. This will streamline the process and minimise delays by identifying issues at an earlier stage, reducing duplication and providing a single point of contact for sponsors.
CREs reviewing through the HRA Radiation Assurance process will be undertaking a professional role supporting a UK-wide process, and contributing to improved healthcare in the UK. The Health Research Authority will coordinate the service to a process agreed across the UK.
Role Details
Accountable to:
- Health Research Authority
Liases with:
HRA Technical Assurances Manager
HRA Technical Assurances Officers
Clinical Radiation Expert Reviewers
Medical Physics Expert Reviewers
Four Nations Radiation Assurance Working Party
Time commitment:
A minimum of 5 CRE reviews per annum (this is a minimum for HRA-managed studies only. This may be more or less for those reviewers undertaking self-managed reviews on behalf of their Trust).
Benefits:
HRA registered CRE reviewers who are members of the Royal College of Radiologists (RCR) can claim 1 CPD point per review completed through Radiation Assurance.
Role description
- To work collaboratively as part of a network of MPE and CRE reviewers to deliver the Radiation Assurance process.
- To justify the proposed investigations as meeting the required aims of the study on the basis of the information contained in the Research Exposure Form (Part F1) and the study documentation in accordance with HRA guidance.
- To complete the CRE form (Part F3) within the Research Exposure Form according to the HRA guidance in language comprehensible to a lay person and return this to the HRA within specified timescales.
- To liaise with the HRA Technical Assurances Officers regarding any issues relating to the justification which need clarification from the study sponsor.
- To check and authorise the completed review once inserted into IRAS, when requested by the applicant or study sponsor and within the timelines specified by the HRA.
- To report and highlight any issues/concerns to the HRA regarding the Radiation Assurance process as part of the continuous quality improvement cycle.
- To perform quality control checks on reviews conducted by other CRE reviewers according to guidance and within the timelines specified by the HRA. It is anticipated that this should be no more than two quality assurance checks per year.
Personal specification
Education/qualifications
| Education/qualifications | Evidence |
| Registered clinical radiologist, clinical oncologist, dentist, or other medical practitioner with clinical expertise in one or more modalities (imaging/treatment method) used in research studies. | GMC registration certificate for doctors or GDC registration certificate for dentists. Curriculum vitae. |
Professional appointments
| Professional appointments | Evidence |
| Expertise in the UK regulatory and clinical environment. | Employer's Letter |
| Appointed as an IRMER practitioner. | Employer's Letter |
Knowledge, skills and experience
| Knowledge, skills and experience | Evidence |
| Appropriate, structured experience of using judgement, skill and specialist knowledge to act as a clinical radiation expert under IRMER in own specialist area. | Curriculum vitae/employer's letter |
|
Experience of carrying out local IRMER compliance reviews as a CRE in departments using ionising radiation. Guidance for HRA-managed reviewers: five local reviews and five lead assessments within the last five years would provide appropriate experience. Where this number cannot be met please contact radiation.assurance@hra.nhs.uk to discuss how to progress your application further. Self-managed reviewers may have less experience than HRA-managed reviewers but should still have recent experience of conducting local reviews and assessments. |
Employer's letter/covering letter |
CRE areas of expertise
| CRE areas of expertise | Evidence |
| Conversant with research undertaken in one or more disciplines e.g. cardiology, dentistry, neurology, oncology, orthopaedics, paediatrics, respiratory, rheumatology, vascular etc. | Curriculum vitae/covering letter/employer's letter |