State Institue for Drug Control (SÚKL) specified the requirements for the documents to be submitted with Part II of the application for clinical trial authorization on January 26, 2022.
Requirements to be entered into Clinical Trial Information System (CTIS) in Part II is elaborated for following sections:
- Patient information sheet / informed consents
- Materials for trial subjects
- Recruitment materials
- Trial site
- Personal data processing
- Biological samples for future research
- Trial subject remuneration and compensation
- Financial coverage – how the clinical trial will be financed
- Proof of fee payment
For more detailed information, click here.