Written internal approval

For the use of ionizing radiation in patient/test subject studies, an approval by the Radiation Protection Unit Randwyck is obliged. 

After positive review, a Written Internal Approval (SIG) will be granted, and sent in the form of an approval letter. 

The Radiation Protection Unit will assess the study based on different factors, for which we need the following information:

• Study title, and short title;
• METC number for the study (in the format NLxxxxx.xxx.xx);
• Institution, department and name of the principal investigator within the Randwyck Complex;
• Number of test subjects (derived from the METC application), age, gender and medical situation of all test subjects participating in the study (whether or not patients); 
• Intended benefit (direct therapeutic effect) for test subjects/patients, as a direct consequence of participation in the study;
• Number of, nature of, dose of (in mSv) and departments involved in the applied examinations, using ionizing radiation, within the Randwyck complex;
• Information about the risks of exposure to ionizing radiation, which will be supplied to the test subjects or patients, prior to participation in the study (in which risks and doses are related to for example the natural background radiation).

For gathering this information, at minimum the following documents are required:

• ABR form;
• Study protocol;
• Patient information form (PIF);
• Quotation Dept. of Medical Imaging (if applicable);
• All other relevant documents.

You can provide the requested information via e-mail: stralingsbeschermingseenheid@maastrichtuniversity.nl.