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:

  1. the medicinal product is used exclusively under the conditions mentioned in the marketing authorization;
  2. the non-interventional study does not necessitate any additional diagnostic or therapeutic measures and hence does not additionally burden the patients;
  3. 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

At Mag. Andreas Raffeiner GmbH, we are well-aware of the increasing importance of non-interventional studies in Austria. Hence, we offer comprehensive NIS monitoring services, including:

  • Design and development of an observational and analysis plan;
  • Submission to the Ethics Committee and notification/reporting to the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG);
  • Trial site selection and site support;
  • Customized and affordable eCRF solutions;
  • Data management and documentation;
  • Compilation of adverse events and adverse event reporting;
  • Analysis and creation of a final report.