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Conducting Clinical Trials (CCT)

Module Title: Conducting Clinical Trials

Module No.:

CCT

Semester / Term:

--

Duration:

1 Semester

Module Type(s):

Pflicht

Regularly offered in:

WS, SS

Workload: 150 h

Credit Points: 5

Admission Requirements:

None

Language of Instruction:

Englisch

Contributing Courses to Module:

Workload:

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

Course Coordinator(s) / Tutor(s):

Dr. Dagmar Peitsch

Module Director:

Dr. Dagmar Peitsch

References to Other Programs:

• N/A

References to Other Modules in the Program:

• Clinical Data Management

Qualification and Educational Objectives of the Module:

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

Course Content of the Module:

• 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

Teaching Methods:

See the contributing course outline(s)

Literature:

See the contributing course outline(s)

Percentage of the Module Grade Relative to the Final Grade for the Program:

--

Prerequisites to Qualify for Assessment:

Assessment:

See course outline(s)

Exam, 90 minutes (100%)