OGEYI, Hungary, specified the requirements in English for the documents to be submitted with Part I and II application for clinical trial authorization on February 23, 2022.
Requirements to be entered into Clinical Trial Information System (CTIS) in Part I and II are elaborated for following sections:
- Annex I
- Cover Letter
- Labelling of Investigational Medicinal Product
- Subject Information and Informed Consent
- Suitability of Investigator
- Suitability of Facilities
More information can be found here.