How and when to submit research applications to ARSAC
- Administration of Radioactive Substances Advisory Committee
- First published:
- 30 October 2014
- Last updated:
- 5 May 2015, see all updates
Guide to submitting research applications to the Administration of Radioactive Substances Advisory Committee (ARSAC).
The research application process is split into 2 parts:
- the study assessment
- the individual site application
Application forms are generated within the Integrated Research Application System (IRAS), and are also available in our publications section. The study sponsor should submit the study assessment, and the ARSAC certificate holder should submit the individual site application.
Study assessment - to be submitted by the study sponsor
You should check and electronically sign the Preliminary Research Assessment (PRA) form in IRAS, before emailing it to the ARSAC Support Unit with a copy of the Participant Information Sheet (PIS). Ideally, this should be emailed to the ARSAC Support Unit at the same time as the NHS Research Ethics Committee (REC) application has been submitted to the NHS REC.
Any questions raised by ARSAC as part of the assessment process, or requests for further information, will be emailed to the study sponsor directly. Once complete, the results of ARSAC’s assessment will be emailed to the sponsor.
Individual site application - to be submitted by the ARSAC certificate holder
You should submit the following forms in hard copy with ink signatures to the ARSAC Support Unit:
- parts A and C of the ARSAC full application form
- the Research Certificate Application (RCA) form only
You may submit your application at any time after the PRA has been submitted. If an application is received prior to submission of the PRA, the ARSAC Support Unit staff will contact the study sponsor and request copies of the PRA and PIS.
If the PRA has been approved by ARSAC at the time your application is received, the ARSAC Support Unit will aim to have the certificate issued and authorised within a week.
Please note that the site application for any study that has been assessed through IRAS must be sent to ARSAC using the RCA form. If there are any site specific variations to the study these can be added to the RCA form electronically or by hand.
For studies that pre-date the IRAS system, the ARSAC B4 with a 1-page summary will continue to be accepted.
From 1 September 2015 any application received by the Support Unit on an incorrect form will be returned.
ARSAC Support Unit
Questions about applications
ARSAC Support Unit
Centre for Radiation, Chemical and Environmental Hazards
Public Health England
Telephone 01235 825006 / 01235 825007
Variations to numbers of participants at individual centres
Following the changes to the research processes in March 2013, there is no set number of patients associated with each certificate at individual centres. Clinicians holding research ARSAC certificates do not need to submit variation requests to ARSAC to increase in participant numbers at their site.
Published: 30 October 2014
Updated: 5 May 2015
- Updated guidance on individual site applications - to be submitted by the ARSAC certificate holder.
- First published.