Inhalt
[ 405ERSLGCPK26 ] KS GCP Basic Training
|
|
|
|
| (*) Leider ist diese Information in Deutsch nicht verfügbar. |
 |
| Workload |
Ausbildungslevel |
Studienfachbereich |
VerantwortlicheR |
Semesterstunden |
Anbietende Uni |
| 0,5 ECTS |
R - Doktorat / PhD |
Humanmedizin |
Rupert Langer |
0,5 SSt |
Johannes Kepler Universität Linz |
|
|
|
| Detailinformationen |
| Anmeldevoraussetzungen |
Zulassung zum Doktoratsstudium Medical Sciences
|
| Quellcurriculum |
Doktoratsstudium Medical Sciences 2026W |
| Lernergebnisse |
Kompetenzen |
| (*)Participants demonstrate a foundational understanding of regulatory and ethical requirements for conducting clinical research. They can apply principles of Good Clinical Practice (GCP) and national/international regulations (e.g., ICH-GCP, AMG) to ensure compliance and integrity in clinical studies. They are able to critically assess research protocols and procedures in accordance with ethical and regulatory standards.
|
|
| Fertigkeiten |
Kenntnisse |
(*)- Identify and interpret key regulatory requirements for clinical research.
- Apply GCP principles to the planning, conduct, and documentation of clinical trials.
- Assess clinical study protocols and procedures for compliance with ethical and regulatory standards.
- Prepare documentation required for submission to ethics committees and regulatory authorities.
|
(*)- Fundamental principles of ICH-GCP, AMG, and other relevant regulatory frameworks.
- Ethical requirements and responsibilities of investigators in clinical research.
- Regulatory procedures for submitting clinical study documents to ethics committees and authorities.
- Requirements for GCP certification and continuing medical education (CME) credits.
- Role of regulatory compliance in ensuring participant safety, data integrity, and scientific validity.
|
|
| Beurteilungskriterien |
(*)Attendance and active participation to the full appointment is mandatory to validate the ECTS.
|
| Lehrmethoden |
(*)Frontal instruction with practical examples and guided discussions.
|
| Abhaltungssprache |
Deutsch |
| Lehrinhalte wechselnd? |
Nein |
| Sonstige Informationen |
(*)This course is offered, in German, by the Competence Center for Clinical Studies (KKS Linz).
Only attendance to the Basic Training course and not the Refresher Trainings can be validated.
|
|
|
|
| Präsenzlehrveranstaltung |
| Teilungsziffer |
10 |
| Zuteilungsverfahren |
Zuteilung nach Vorrangzahl |
|
|
|
