Both of these assurances will eventually become an integrated component of HRA Approval in England as part of our ongoing work to streamline and improve the research approval process.
Two working parties made up of expert representatives from the four nations are contributing to the guidance and process documents. Current areas of development are:
- finalising the pharmacy technical review form to ensure it incorporates national variations and can be used UK-wide
- guidance for sites, sponsors and reviewers to cover payments, amendments and the review process
- confirmation that amendments will not need to be processed for pharmacy assurance following completed review
- developing two routes to gaining Technical Assurances – HRA centrally-managed review or sponsor self-managed review. More information on this development will be available on the HRA website and in future editions of HRA Latest.
Additionally, our generic ionising radiation risk statements for use in participant information sheets (PIS) and IRAS are still within the ‘consultation in use’ period, which is open until 31 August 2017.
We have developed these statements in conjunction with a group of radiation experts for use by sponsors and medical physical experts (MPEs) and clinical research experts (CREs).
Feedback on the statements or any other queries regarding radiation assurance can be sent to email@example.com.
Queries regarding pharmacy assurance can be sent to firstname.lastname@example.org.
We will be recruiting MPEs, CREs and pharmacy reviewers later in the year, with recruitment open to all specialisms in the first instance.
This opportunity will be advertised widely, with all relevant information made available on our website.