Non-interventional study – NIS
The term ‘observational study’ (also ‘in-use study’) was mentioned for the very first time in the Austrian Medicinal Products Acts (Arzneimittelgesetz; AMG) in the year of 1994. Its primary purpose was to differentiate this type of study from a clinical trial. However, in view of the terminology commonly used in Europe, an amendment to the AMG replaced the term “observational study” by the term “non-interventional study”, abbreviated as “NIS”.
NIS is a systematic study of approved medicinal products on patients, provided that:
- the medicinal product is used exclusively under the conditions mentioned in the marketing authorization;
- the non-interventional study does not necessitate any additional diagnostic or therapeutic measures and hence does not additionally burden the patients;
- the use of a particular therapeutic strategy is not stipulated in a trial protocol, it is in accordance with the medical doctrine, and the decision to prescribe the medicinal product is unequivocally separated from the decision to enroll a patient in the study.
If the definition criteria are met, the following may be considered depending on the study design:
- PMOS: Post Marketing Observational Studies
- Evaluation of registry data
- PASS: Post authorization safety studies
- Correlational studies with aggregated data
- Case-control studies
NIS service offerings
- Design and development of an observational and analysis plan;
- Data management and documentation;
- Submission to the Ethics Committee and notification/reporting to the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG);
- Compilation of adverse events and adverse event reporting;
- Analysis and creation of a final report.
- Trial site selection and site support;
- Customized and affordable eCRF solutions;