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

HL7 Electronic Health Record System Functional Model, Release 2.1.1, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 2.1.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ehrsfm-ig/ and changes regularly. See the Directory of published versions

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

Official URL: http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CPS.3.5 | Version: 2.1.1
Standards status: Normative Active as of 2025-12-13 | Computable Name: CPS_3_5_Support_for_Research_Protocols_Relative_to_Individual_Patient_Care

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.