Retrieval of Real World Data for Clinical Research
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Retrieval of Real World Data for Clinical Research, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/vulcan-rwd/ and changes regularly. See the Directory of published versions

Finding Data

Fetching Patient Records

Getting access to the EHR to be able to retrieve patient records is accomplished by following the requirements of International Patient Access. This guide provides additional details on the needed queries and the relevant data elements that are important for supporting clinical research.

Medication Summary

To receive medication summary information, a requesting system will have to query the four different Medication workflow resources to find all information about a patient’s medications.

Resource Type Query
MedicationRequest [base]/MedicationRequest?patient=Patient/[patient id]&authoredon=ge[history date]
MedicationDispense [base]/MedicationDispense?patient=Patient/[patient id]&whenhandedover=ge[history date]
MedicationAdministration [base]/MedicationAdministration?patient=Patient/[patient id]&effective-time=ge[history date]
MedicationStatement [base]/MedicationStatement/patient=Patient/[patient id]&effective=ge[history date]

The IPA MedicationRequest and IPA MedicationStatement profiles along with the IPA Medication profile provide the necessary information that are important to RWD. This guide defines a profile on MedicationDispense and MedicationAdministration because those resources are important to get a complete picture of the medications that a patient is taking. See the Medications section of this guide for more information on determining a patient’s medications.

Problem List

To receive the problem list, the following query for conditions should be made:

[base]/Condition?patient=Patient/[patient id]&recorded-date=ge[history date]

The IPA Condition and IPA Problem List Item profiles provide the necessary information for RWD.

History of Procedures

To receive procedures for a patient, the following query for procedures should be made:

[base]/Procedure?patient=Patient/[patient id]&date=ge[history date]

This guide defines a Procedure profile since the IPA guide does not.

Diagnostic Results

To receive observation results for a patient, the following query for observations should be made:

[base]/Observation?patient=Patient/[patient id]&date=ge[history date]

This guide defines a Laboratory Results profile that adds component observations to the base IPA Observation profile.

Patient Visits

To receive patient visits for a patient, the following query for encounters should be made:

[base]/Encounter?patient=Patient/[patient id]&date=ge[history date]

This guide defines an Encounter profile since the IPA guide does not.