The CommCare platform is widely used by global health research teams for their data collection or mHealth intervention needs.
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#2 Which studies, past or on-going, use CommCare?
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#5 Is CommCare 21 CFR Part 11 compliant?
CommCare is 21 CFR Part 11-ready, meaning that if implemented in conjunction with appropriate procedures, documentation, and qualification, then your study may meet part 11 requirements. CommCare has the technical features necessary to serve as the data collection and management component of a 21 CFR Part 11 compliant study. However, a study using CommCare must have policies, procedures, training, validation and documentation meeting the requirements of Part 11 and the predicate rules for the underlying legislation. An FDA auditor will review all project documentation to determine at the study level if a study is compliant.
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