Content
The focus of this seminar is on conducting and evaluating a clinical trial. First, the “study start-up” activities and central documents will be examined in more detail and an insight into the various study registers that can be used will be provided.
Critical processes during implementation are then examined, especially vigilance and safety reporting, and ultimately a link is drawn to the processes at the end of the study: evaluation, completion of the study, reports, archiving, publications.
Topic overview
- “Study start-up” activities and central documents: Informed Consent Design, Case Record Forms (CRF design), Trial Master File (TMF)/ Investigator Site File (ISF) setup
- National/international study register
- Vigilance/reporting of adverse events and product defects (SAE, AE and DD)
- Evaluation (data management, database log, statistical evaluation)
- Test report, deadlines, publication
- Archiving
target group
Employees from the areas of clinical and regulatory affairs, product management, business development, project managers, consultants, service providers for medical devices, authorities.
Prior knowledge
Knowledge of the EU MDR is recommended.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
