The following procedures are related to changes to be assessed by VWSMinistry of Health, Welfare and Sport .

See CCMO changes for the types of changes that must be reported to the Minister of VWS. Assessment of a substantial amendment by the Minister of VWS requires submission of the following documents only:

  1. A hardcopy version of the signed cover letter. For an example please refer to the CCMOCentral Committee on Research involving Human Subjects website, ´standard research file´;
  2. The EudraCT Substantial Amendment Notification form as a PDF file on a CD-ROM (see the CCMO website, ´Changes in research file’);
  3. If applicable, the amended EudraCTEuropean Union Drug Regulating Authorities Clinical Trials application form in digital form, both as a PDF file on CD-ROM and in XML format via ToetsingOnline.