What is meant by Observational studies?
Observational studies are non-interventional studies in the field of medical research designed to gather insights on the application of approved or registered medicinal products. They allow for the collection of information about the safety, efficacy, and use of medications under real-world conditions.
Typical software functions in the area of "observational studies":
- Data collection: Structured input of patient data, medication applications, and observations
- Study planning: Creation and management of observation plans
- Patient management: Administration of patient information and informed consent forms
- Event documentation: Recording of adverse events and side effects
- Data analysis: Statistical analysis and visualization of collected data
- Report generation: Creation of interim reports and final reports
- Compliance monitoring: Ensuring adherence to regulatory requirements
