Frequently Asked Questions
1. How much does it cost for a copy of the Notes for Guidance and for an ARSAC certificate?
There are no costs involved. It should be noted that copies of the Notes for Guidance can be downloaded from the ARSAC website. Hardcopies can be obtained by contacting the ARSAC Support Unit.
2. Can my completed application form be sent electronically or by fax?
No – it is a requirement that we hold original signatures.
3. What is the process when an application is submitted?
The flow diagram in Appendix VI of the ARSAC Notes for Guidance describes the complete process for all new applications. Processes for renewals etc are simpler but still involve consultation with Committee members and/or assessment by the scientific adviser.
4. What training and experience is needed to apply for an ARSAC certificate?
This will depend on the procedures you wish to undertake. Please refer to Appendix IV of the ARSAC Notes for Guidance for full details.
5. When does the Committee meet to assess the applications?
The Committee does not meet as a whole to assess the applications. The members appointed will assess each application individually and the ARSAC Support Unit will collate the responses. Please refer to Appendix VI of the ARSAC Notes for Guidance for further details.
6. How long does it take for a new application to be processed?
Where the original application includes all the information required for assessment, certificates are normally issued within six weeks of receipt of application. Please refer to section 2.21 of the ARSAC Notes for Guidance for further details.
7. If radioactive medicinal products are supplied from another hospital, who should sign Part C6 of my application form?
Both the local scientist responsible for the provision of these radioactive medicinal products at the originating hospital, and the local scientist who is responsible for the acceptance of radioactive medicinal products at the site where the procedure is to take place.
8. Where does the RPC reference number come from and what does it represent?
On receipt of an application, an RPC reference number is allocated by the ARSAC Support Unit.
This is included in the acknowledgement letter sent to the applicant.
The RPC reference number e.g. 123-456 (99999) is made up of three parts:
The first part –123- represents the site for which the certificate is issued.
The second part –456- is the unique clinician number.
The third part – 99999- is the application or certificate number.
The RPC reference number is a unique identifier and should be quoted in all correspondence regarding an application.
9. What is the minimum dose above which an ARSAC certificate is required and over what period?
Where the patient or subject receives an effective dose of more that 1 micro sievert (0.001mSv) from all the administrations included within the application, an ARSAC certificate is required.
10. Is an ARSAC certificate required for routine or research use of x-rays or CT scans?
No – the MARS regulations do not apply to x-rays or CT scans. Please refer to paragraph 1.17 of the ARSAC Notes for Guidance. You should however, include information about the dose from such exposures as part of any research application under MARS involving the use of radioactive medicinal products.
11. Can I continue to work under a colleague’s certificate when he is absent?
Yes, if it is only a short-term temporary absence, provided you are working under the certificate holder's written directions. Please refer to paragraph 2.4 of the ARSAC Notes for Guidance.
If the certificate holder will be absent for a longer period, during which it is reasonable to expect written directions will need to be changed or reviewed (e.g. 6 months maternity leave or a sabbatical) then it will be necessary for another individual to be certificated under MARS. Please refer to paragraph 2.5 of the ARSAC Notes for Guidance.
12. Will I need a separate certificate to undertake PET procedures using a mobile scanner?
This will depend on where the mobile unit will be located.
a. If the mobile unit is to be located at a site for which you already hold a diagnostic certificate, you should complete the additions form for the PET procedures you wish to undertake.
b. If the mobile unit is to be located at a site for which you do not hold a certificate you should complete the full form.
In both cases a new Part C (from the full form) must be fully completed and signed by the supporting staff available to you at the mobile unit.
Please refer to paragraph Appendix IV Parts B and C of the ARSAC Notes for Guidance for further details.
13. Which form should I submit if my research certificate expires before the research study is complete?
You will not need to complete a new form. The certificate holder should request, by letter, the justification for the extension. This letter should be signed by the certificate holder.
14. In research studies, should I keep the radiation dose to volunteers below levels in WHO categories?
No – ARSAC assesses each application on its own merits and while it is important to keep doses as low as reasonably practicable, the activity administered (and the resulting dose) should be that necessary to provide the information required.
15. What influence has the European Clinical Trial Directive (2004) had on academic trials?
This question was addressed in an editorial by Keith Harding and Stephen Mather; published in Nuclear Medicine Communications January 2007, Volume 28, Issue 1. http://www.nuclearmedicinecomm.com
16. For Multicentre research studies, does one centre hold the certificate to cover all participating centres?
No. All participating centres must apply for a certificate in their own right. All certificates are site specific.
Note
All references relate to ARSAC Notes for Guidance dated March 2006