Phenotype harmonization must be recognized early on as a key requirement for cross-study collaboration. Key personnel should be identified and, depending on the complexity, size, number, and primary endpoints of the participating studies, a group or committee should be established or identified that takes responsibility for directing and overseeing phenotype harmonization activities. In GENEVA, three groups are involved in phenotype harmonization: a Phenotype Harmonization Subcommittee (PHS); the phenotype-specific Working Groups (WGs); and the Coordinating Center (CC) (Figure 1).
