- Clinical trial protocols
- Protocol synopses
- Patient information and informed consent forms and their updates based on the requirements of the Ethics committees
- Labelling for investigational medicinal products
- Clinical trial agreements and their amendments
- Promotinal materials (Dear Doctor letters, posters, advertising for media, etc.)
- IVRS/IWRS localizations
- Source data (medical, discharge, laboratory, autopsy reports, etc.)
- Localizations for patient e-Diaries and other software
- Scales and questionnaires for patients and physicians
- Letters from SÚKL/Ethics committees regarding the applications for approval of a clinical trial and requests for additional data