Team leader: N.N.

Email:

Phone:

Approval and assumption of reporting obligations for a clinical trial

• Investigation plan (study protocol)
• Patient information and informed consent form
• Final report

• Regulatory classification of a clinical trial project
• Approval application for international multicentre clinical trials via Voluntary Harmonization Procedure (VHP) in advance of national submissions
• Approval application and Communications with national and international higher authorities
• Evaluation application and Communications with Ethics Committees
• Application of the new EU Regulation (EU) 536/2014 from the date of validity
• Notification obligations to supervisory authorities
• Management of change notifications ("amendments")
• Management of subject insurance
• Safety notifications