Layout Part II application in CTIS
In CTIS, there is one section (Part II) to complete for an initial application of Part II.
Part II
Trial sites: Register name and location of the clinical trial site plus the name of the investigator. Only register clinical trial sites if the documentation (CV investigator, DOI investigator and VGO) is complete and uploaded in CTIS for this trial site.
Documents Part II:
- Recruitment arrangements
- Subject information and informed consent form
- Suitability of the investigator
- Suitability of the facilities
- Proof of insurance cover or indemnification
- Financial and other arrangements
- Compliance with national requirements on data protection
- Compliance with use of biological samples