Vigilance for clinical trials
SAE Reporting
The integration of individual clinical expertise with the best available external evidence from systematic research makes Hannover Medical School a leading location for clinical research. A quality-assured infrastructure provides the platform for clinical trials with medicinal products and medical devices in accordance with applicable national and international standards.
The compliant recording, evaluation and reporting of adverse events in clinical trials are subject to particularly careful scrutiny during inspections by the authorities. The Vigilance Unit of the Institute of Clinical Pharmacology supports clinical researchers in all matters relating to the safety of medicinal products and medical devices in clinical trials with specialist expertise in a safe environment.
- New creation of pharmacovigilance-specific sections in the protocol
- Individual design of Serious Adverse Event (SAE) reporting forms
- Individual design of Adverse Event (AE) forms
- Creation of pharmacovigilance-specific sections of the DMC charter
- Receipt and documentation of Serious Adverse Event (SAE) reports. Evaluation and information of the study management
- Standardized reporting of Serious Adverse Events (SAEs) to the marketing authorization holder of the investigational medicinal product
- Electronic E2B-compliant reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to the competent national or European authority
- Preparation of the annual safety report (Development Safety Update Report, DSUR formerly: Annual Safety Report)
- Evaluation of electronically available Serious Adverse Event (SAE) reports on the investigational product from other studies
- Receipt and documentation of Serious Adverse Event (SAE) reports, evaluation and forwarding to the competent authority
- Notification of serious adverse events (SAEs) to the marketing authorization holder of the investigational medicinal product
- Preparation of quarterly safety reports
Contact person:
PD Dr. med. Christoph Schröder
Specialist in Internal Medicine
Head of Pharmacovigilance in Clinical Trials
Phone: 0511 - 532 3959
Fax: 0511 - 532-162794
Email: sae-reporting@mh-hannover.de
Information sheet for a brief overview of important details
Pharmacovigilance in clinical trials