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

If, in addition to approval of the clinical trial in accordance with EU Regulation 536/2014, notification in accordance with Section 32 StrlSchG is also required, this should be done as part of the CTR submission in CTIS. It is essential that the cover letter clearly states that an additional notification procedure in accordance with Section 32 StrlSchG is required (see also Section 32 StrlSchG (c)). It must also be stated whether radioactive substances or ionizing radiation are involved. All necessary documents in accordance with Section 32 StrlSchG must be uploaded to CTIS in Part II (Section N_Suitability of Facility).

Further information can be found on the website of the Working Group on Medical Ethics Committees (Arbeitsgruppe Medizinischer Ethik-Kommissionen, AKEK).

A decision on the notification procedure in accordance with Section 34a StrlSchG (condition, time limit, or requirement) or in accordance with Section 34 StrlSchG (prohibition) will be uploaded to CTIS and forwarded to the sponsor in this way.

If a substantial modification is submitted in CTIS for which a notification in accordance with Section 32 StrlSchG already existed before July 1, 2025, then a) this must be stated in the cover letter, including whether radioactive substances or ionizing radiation are involved, and the relevant documents must be uploaded in Part II (section N_Suitability of Facility), and b) at the same time as submitting a substantial modification in CTIS, an additional email must be sent to ctr@bfarm.de, indicating that these studies also affect the substantial modification procedure under Section 32 StrlSchG.

If a notification procedure pursuant to Section 32 StrlSchG is only required as a result of changes made in a substantial modification, this must be stated in the cover letter. Furthermore, information must be provided as to whether radioactive substances or ionizing radiation are involved. The required documents must be uploaded in Part II (Section N_Suitability of Facility). At the same time as submitting the substantial modification, an additional email must be sent to ctr@bfarm.de, stating that this is a notification procedure pursuant to Section 32 StrlSchG.