How does Quorum define a Major Protocol Deviation/Violation (PD)?

Quorum defines a Major Protocol Deviation/Violation as any intentional or unintentional change from the IRB-approved protocol that adversely affects the risk/benefit ratio of the study; the rights, safety, or welfare of the participants or others; or the integrity of the study. Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information.