Per Protocol Population. The Per-Protocol (PP) population includes subjects in the mITT population who complied with treatment and did not have any protocol violations. A protocol violation is defined as a deviation from basic requirements of the study protocol, including inclusion and exclusion criteria, concomitant medication restrictions, or any other protocol requirements that result in a significant added risk to the study subject or has an impact on the quality of the data collected or the outcome of the study. A protocol deviation is defined as a deviation from the protocol that does not impose added risk to the study design or the study subject. The criteria for the determination of the evaluability of subjects will be defined in the Statistical Analysis Plan.
Appears in 2 contracts
Sources: Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)