The following information must be observed and apply to studies processed by both the BfArM or the PEI.

If, in addition to the approval of the clinical trial in accordance with EU Regulation 536/2014, an application must also be submitted in accordance with Section 31 StrlSchG, this should be done as part of the CTR submission in CTIS. For this purpose, it is essential that the cover letter clearly states that an application for approval in accordance with Section 31 StrlSchG is being submitted (see also Section 31a StrlSchG). All necessary documents in accordance with Section 31a StrlSchG must be uploaded to CTIS in Part II (Section N_Suitability of Facility). Further information on the naming conventions for these documents can be found on the website of the Federal Office for Radiation Protection (BfS). The Federal Office for Radiation Protection (BfS) and the responsible ethics committee will be informed by the BfArM of the receipt of the application.

If a substantial modification is submitted in CTIS for which approval has already been granted in accordance with Section 31 StrlSchG before July 1, 2025, then a) this has to be stated in the cover letter and the relevant documents must be uploaded in Part II (Section N_Suitability of Facility) and b) at the same time as submitting the substantial modification in CTIS, an additional email must be sent to ctr@bfarm.de stating that these studies also concern the approval procedure under Section 31 StrlSchG.

If approval pursuant to Section 31 StrlSchG is only requested through changes within the scope of a substantial modification, this must be stated in the cover letter. The required documents must be uploaded in Part II (Section N_Suitability of Facility). At the same time as submitting the substantial modification in CTIS, an additional email must be sent to ctr@bfarm.de stating that this substantial modification concerns the approval procedure under Section 31 StrlSchG.

Further information on the approval procedure pursuant to Section 31 StrlSchG can be found on the homepage of the BfS and the Working Group of Medical Ethics Committees (AKEK).