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Conducting Clinical Trials (CCT)

Modulbezeichnung: Conducting Clinical Trials

Modulnummer:

CCT

Semester:

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Dauer:

1 Semester

Modultyp:

Pflicht

Regulär angeboten im:

WS, SS

Workload: 150 h

ECTS Punkte: 5

Zugangsvoraussetzungen:

None

Unterrichtssprache:

Englisch

Kurse im Modul:

Workload:

Lectures: 30 h
Self-study: 90h
Self-examination: 30 h

Kurskoordinatoren/Tutoren::

Dr. Dagmar Peitsch

Modulverantwortliche(r):

Dr. Dagmar Peitsch

Bezüge zu anderen Programmen:

• N/A

Bezüge zu anderen Modulen im Programm:

• Clinical Data Management

Qualifikations- und Lernziele des Moduls:

This course enables students to deepen insight into Clinical Research, standard trial documentation procedures and more challenging settings during a clinical trial.

Lehrinhalt des Moduls:

• International guidelines and local requirements for the conduct of clinical trials
• The Trial Master File
• Clinical Monitoring: Types of visits; Special tasks and challenges of each visit type, including Source Data Verification, Case Report Forms (CRF) and queries, Adverse Events and Test article handling procedures
• Current trends in monitoring: principles of the Risk-Based-Monitoring approach
• Quality Control: Handling of protocol deviations: how to detect and categorize deviations
• Quality assurance: Audits and inspections

Lehrmethoden:

See the contributing course outline(s)

Literatur:

See the contributing course outline(s)

Anteil der Modulnote an der Gesamtabschlussnote des Programms:

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Prüfungszulassungsvoraussetzung:

Abschlussprüfungen:

See course outline(s)

Exam, 90 minutes (100%)