Observational protocol

Abstract

An observational study (OS) is a non-interventional/non-experimental survey. In the OSs, the investigator observes and evaluates results of ongoing medical care without 'controlling' the therapy beyond normal medical practice. An OS is aimed: 1. to the evaluation of the safety profile of any medical procedure (drug, device, surgical procedure, radiotherapy, diagnostics, etc.) under the normal conditions of use and on great numbers of patients, 2. for close examinations on the effectiveness in the clinical practice, 3. for the verification of the prescriptive appropriateness and 4. for pharmacoeconomic evaluations. For their characteristics OPs don't involve additional risks for the patients to which the best conditions of clinical assistance are offered. Consequently they do not need further or different ethical procedures/ requirements in comparison to the experimental clinical studies Particularly it is necessary to avoid that an interventional trial could be introduced as an OP.