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        Master's degree programme Certificate course Single modules Application Student advisory service Examination board
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        Study plan (MDRA-26) Study modules (MDRA-26) Study modules (MDRA-25) Internship Master's thesis Lecturer Literature
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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 10 Clinical Documentation

Documentation of drug trials on humans, clinical trial samples, observational studies and experience reports

  • Overview
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 30 hours ca. 30 hours Study paper and written examination 6
Module leader
Dr. Ingrid Klingmann

Module contents

1 Basics of Clinical Trials

  • Definition of the clinical trial
  • Phases of the drug trial
  • Application observations

2 Good Clinical Practice

  • Terminology
  • Essential documents
  • Archiving
  • Audit

3 GCP Inspections

4 Ethics in Clinical Research

  • Declaration of Helsinki
  • Ethics approval process
  • Informed consent

5 Investigational Medicinal Products Documentation

6 Relevant Items in Clinical Trials

7 Clinical Pharmacology

  • Phase I studies - background
  • Pharmacokinetics, ADME
  • Bioavailability
  • Populationkinetics
  • Pharmacogenetics
  • Pharmacodynamics
  • PK/PD-Correlation

8 Biometry in Clinical Research

  • Statistical analysis
  • Study designs
  • Multiple testing
  • Case ascertainment
  • Data management
  • meta-analysis
  • Subgroup analysis
  • Interim analysis
  • Epidemiology

9 Clinical Trial Guidelines 1

  • Women
  • Elderly
  • Children
  • Vulnerable subjects

10 Regulatory Process in Clinical Development

  • Paragraphs in the AMG
  • Submission
  • Monitoring, audits, inspections
  • European specialities

11 Clinical Trial Directive 2001/20/EC

  • Chiral active substances
  • Fixed combination medical products

12 Clinical Trials Guideline 2

  • Vaccines
  • Immunoglobulines
  • Plasma-derived factors
  • Recombinant factors

13 Clinical Development of Vaccines

  • Background
  • European public assessment reports

14 Clinical Development of Blood Products

  • Background
  • European public assessment reports

15 Clinical Trials Guidelines 3

  • Drug Interactions
  • QT-Interval prolongation
  • Control group
  • Modified release dosage forms

16 Safety in Clinical Trials

  • Definition
  • Causality assessment
  • Obligation to report, notifications
  • Guidelines
  • Step-by-step plan

17 Clinical Trial Guidelines 4

18 Clinical Section of Application Dossier

  • Directive 75/318/EEC
  • Notice to applicants
  • Common technical document

19 Clinical Trial Performance

  • Final group exercise

Study plan

Part 1
Friday 27.06.2025 von 08:30 - 17:50 Uhr Online
Saturday 28.06.2025 von 08:00 - 16:10 Uhr Online
Part 2
Friday 11.07.2025 von 08:30 - 18:00 Uhr Universitätsclub Bonn e.V.
Saturday 12.07.2025 von 08:00 - 16:00 Uhr Universitätsclub Bonn e.V.
Submission of study paper Monday, 11.08.2025  

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