ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build

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

Active as of 2024-11-23
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.

 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.