740869 SE Organisatorische Aspekte in klinischen Studien, Protokoll für klinische Studien, 1 Gruppe

Sommersemester 2026 | Stand: 28.11.2025 LV auf Merkliste setzen
Institut für Pharmazie Institut für Pharmazie
Mag. Barbara Lanthaler, PhD Mag. Barbara Lanthaler, PhD
740869
SE Organisatorische Aspekte in klinischen Studien, Protokoll für klinische Studien, 1 Gruppe
SE 1
1
Block
jährlich
Englisch

Students acquire kowledge regarding clinical trials organisational aspects and protocols, including EUDRACT registration, Clinical Trial Application (CTA) and maintenance (i.e. Substantial Amendments) Ethics Committees Operations, CRO, Site Handling, Oversight and Good Investigator Practice

  • Clinical Trial Application: documents (study protocol, informed consent form, CRFs, Investigator’s Brochure, processes (CTIS), cooperation ECs & CA
  • Study start-up: necessary (additional regulatory & organizational) steps
  • Life-cycle Management of clinical trials: amendments, notifications, reports
  • Clinical conduct: patient recruitment (incl. consent process), documentation
  • Monitoring
  • Pharmacovigilance in clinical trials

seminar applying theoretic knowledge to specific practical situations

active participation in practical course demonstrating understanding of theoretical principles and critical reasoning, presentation of results

Modules 1 and 2

29.04.2024
Gruppe Anmeldefrist
01.02.2026 00:00 - 21.02.2026 23:59
Lanthaler B.