In your studies 'Drug Regulator Affairs'
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
| Teaching time | Study time | Type of examination | Credit points |
|---|---|---|---|
| ca. 30 hours | ca. 30 hours | Study paper and written examination | 6 |
Dr. Ingrid Klingmann
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
| 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 | |