Inhalt
[ 405ERSLGCPK26 ] KS GCP Basic Training
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| (*) Unfortunately this information is not available in english. |
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| Workload |
Education level |
Study areas |
Responsible person |
Hours per week |
Coordinating university |
| 0,5 ECTS |
R - Doctoral programme |
Human Medicine |
Rupert Langer |
0,5 hpw |
Johannes Kepler University Linz |
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| Detailed information |
| Pre-requisites |
(*)Zulassung zum Doktoratsstudium Medical Sciences
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| Original study plan |
Doctoral programme Medical Sciences 2026W |
| Learning Outcomes |
Competences |
| 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.
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| Skills |
Knowledge |
- 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.
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- 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.
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| Criteria for evaluation |
Attendance and active participation to the full appointment is mandatory to validate the ECTS.
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| Methods |
Frontal instruction with practical examples and guided discussions.
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| Language |
German |
| Changing subject? |
No |
| Further information |
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.
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| On-site course |
| Maximum number of participants |
10 |
| Assignment procedure |
Assignment according to priority |
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