What is a clinical investigation?

A clinical trial is a special case of a clinical study to evaluate the safety or performance of a medical device, for which there is a study plan or study protocol that precisely defines all steps in advance (prospectively). A clinical trial can be conducted with very few participants or with hundreds to thousands of participants, either in a single country or internationally.

The following phases are generally distinguished in such a clinical trial: design, planning and set-up, implementation with follow-up, data management, evaluation and interpretation as well as publication. Even if these phases are always necessary, the respective design always depends on the respective legal provisions (regulations), the product, the participants, the risk of the product or the study, the interest of the sponsor (responsible party, usually the manufacturer), the number of digital study elements, the purpose of the clinical trial, the positioning of the product (marketing) or the unmet medical need.