HL7 Electronic Health Record System Functional Model, Release 2.1.1
2.1.1-ballot - Normative Ballot

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## Requirements: CPS.3.5 Support for Research Protocols Relative to Individual Patient Care (Function)

Page standards status: Informative

Statement N:

Provide support for the management of patients enrolled in research protocols.

Description I:

The clinician is presented with appropriate protocols for patients participating in research studies, and is supported in the management and tracking of study participants.

Actors:
ehr Criteria N:

CPS.3.5#01 | SHALL | The system SHALL provide the ability to present protocols for patients enrolled in research studies.
CPS.3.5#02 | SHALL | The system SHALL provide the ability to capture, maintain and render research study protocols.
CPS.3.5#03 | SHOULD | The system SHOULD conform to function AS.9.1 (Support Financial Plan Enrollment), to enable participation in research studies.
CPS.3.5#04 | SHOULD | The system SHOULD provide the ability to analyze and maintain patients participating in research studies.
CPS.3.5#05 | MAY | The system MAY provide the ability to capture and maintain appropriate details of patient condition and response to treatment as required for patients enrolled in research studies.
CPS.3.5#06 | SHALL | The system SHALL conform to function CP.3.3 (Manage Clinical Documents and Notes) to capture patient condition and response to treatment.
CPS.3.5#07 | SHOULD | The system SHOULD capture, maintain and render research subject disposition information including date/time and trial phase/cycle of study completion/discontinuation as discrete elements.
CPS.3.5#08 | SHOULD | The system SHOULD determine patients eligible for known active clinical research protocols as defined by inclusion and exclusion criteria.
CPS.3.5#09 | SHOULD | The system SHOULD present information notifying staff of patient's eligibility for known active clinical research protocols as defined by inclusion and exclusion criteria.
CPS.3.5#10 | SHOULD | The system SHOULD capture research protocol deviation information, including any verbatim text of protocol deviation.