Incorporate Automated Protocol into EHR Specification Revisions Incorporate Automated Protocol into EHR Clinical Trial Sponsor Automated Protocol EHR @ Physician / Investigator Site Automated Protocol Aggregated Subject Data Queries for data clarification Enact Tasks Decision to Implement (by measure and by receiver) Protocol Tasks Build into EHR workflow Study Data Assembled by Sponsor System Internal Interaction and Reporting Transmission of Subject-Specific Data Archived Subject Data Subject Data Entity Action Function Data File Process Step Feedback Mechanism Related Process Step (if required by entity) K E Y

Incorporate Automated Protocol into EHR Specification Revisions Incorporate Automated Protocol into EHR Clinical Trial Sponsor Automated Protocol EHR @ Physician / Investigator Site Automated Protocol Aggregated Subject Data Queries for data clarification RFD Notification Extension Enact Tasks Protocol Tasks Build into EHR workflow Study Data Assembled by Sponsor System Internal Interaction and Reporting RFD Zone Transmission of Subject-Specific Data Archived Subject Data Subject Data