Report termination, discontinuation or interruption of a medical study involving the use of radiation and other changes requiring notification

Service Description

If you, as a person authorized to conduct medical research, are in charge of a study in which radioactive substances and/or ionizing radiation are used on humans ("radiation application"), you must inform the BfS about the following procedures:

  • the termination of the research project,
  • the discontinuation of the study-related use of radioactive substances and/or ionizing radiation,
  • an interruption of the study-related use of radioactive substances and/or ionizing radiation,
  • resumption after the interruption of the study-related use of radioactive substances and/or ionizing radiation, in the case of approved uses, the existence of significant new findings on the benefits associated with the research project, taking into account the medical benefit for the persons included, if applicable, or on radiation-related risks,
  • in the case of multi-center studies, the resignation of a person responsible for radiation protection, and
  • in the case of notified applications, a change with regard to the proof of the required coverage.

With the notification of termination, the permission for further use of radioactive substances and/or ionizing radiation on humans for the purpose of medical research ceases to be valid. For those involved, this means that from this point onwards, no further study-related applications may be carried out as part of this research project.

If a notification concerns a significant change to notified or approved uses of radioactive substances and/or ionizing radiation in humans for the purpose of medical research, this may result in a chargeable amendment procedure.

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

Competent Authority

Bundesamt für Strahlenschutz (BfS)

Postal address
Post office box 10 01 49
38201 Salzgitter

Address
Willy-Brandt-Straße 5
38226 Salzgitter
Telephone
+49 30 18333-0
Fax
+49 30 18333-1885
DE-Mail
epost@bfs.de-mail.de