How and when to submit research applications to ARSAC
- Administration of Radioactive Substances Advisory Committee
- 30 October 2014
- Last updated:
- 25 July 2017, 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. Site specific variations to the study can be indicated on the RCA form electronically or by hand.
For studies that predate the IRAS system, please contact the Support Unit for further advice.
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.
Amendments to research studies
ARSAC should be notified of any changes concerning the administration of radioactive substances as this may affect the approval granted. Such changes include, but are not limited to:
- changes to the study title
- changes to the number of administrations of radioactive substances from Section A1 of the original PRA
- addition or removal of a procedure involving the administration of a radioactive substance
- addition of a new study population with a different clinical condition (including changing of the age of participants)
- changes to the radiation risk information in the PIS
Such changes normally meet the criteria for notifying substantial amendments to the Research Ethics Committee (or GTAC). Notification should be made to the ARSAC Support Unit, by the sponsor, by email with the following:
- short summary of the changes
- notice of Substantial Amendment when this is submitted to the REC
- updated PRA form if there are changes to the number of administrations or procedures involving radioactive substances (note: you will need to revise the integrated dataset Part A or B3, or both and then create an up-to-date PDF of the PRA form via the submission tab)
- any other relevant enclosures, for example a participant information sheet
ARSAC will then contact the sponsor if any further information or action is required. During the assessment of any amendment, the study remains authorised within the bounds of the initial submission and administrations may continue as per the original application.
In a multi-site study, it is not necessary for each site to notify ARSAC of amendments. Once approval has been granted to the sponsor, sites will be authorised to proceed with the amended study for all serials listed on their certificate.
Published: 30 October 2014
Updated: 25 July 2017
- Added 'amendments to research studies' section.
- Updated guidance on individual site applications - to be submitted by the ARSAC certificate holder.
- First published.