REK KULMU is, on behalf of Norway, responsible for assessing documents submitted in the Part II application dossier.
It is recommended to use the templates that are available on the European Commission’s website.
If the sponsor chooses to use other templates, it is the sponsor’s responsibility to ensure that all CTR requirements are fulfilled and that all the requested information in the EU commission’s templates is included in the submitted documents.
Documents marked with “*” must be submitted for each trial site:
- Compensation for trial participants
- Compensation for trial participants
- Investigator Curriculum Vitae*
- Site Suitability Form*
- Recruitment and Informed consent procedure
- Compliance with applicable rules for biological samples (if relevant)
Signature is not required for the above-mentioned documents.
Part II – What should the application contain?
Part II documentation is adapted to each individual Member State participating in the study. All documents attached in Part II must be in English, with the exception of the informed consents and any recruitment material.
