About mapping questions for Electronic Health Record (EHR) data import

If your study is enabled for EHR data import, you can map form questions to EHR elements in an Oracle-managed data dictionary and use pre-seeded EHR code lists to ensure successful data import and minimize data cleaning.

A few extra steps in the design phase can result in more efficiently designed studies with downstream benefits for site users and subjects.

For more information about importing Electronic Health Record (EHR) data and pre-seeded code lists, see Enable Electronic Health Record (EHR) data import and About Electronic Health Record (EHR) code lists.

Prerequisites

Before you can map form questions, the sponsor user must enable the study for EHR data import. For more information, see Enable Electronic Health Record (EHR) data import.

Once enabled, the EHR Mapping setting is available under the Advanced side panel in design mode. No additional permissions are required to use this feature.

Mapping details for study designers

After a study version is moved from the draft container, adding new ERH mappings, updating existing mappings, or removing mappings is only permitted as part of a study version change. Advanced Study Versioning (ASV) is not supported.

Note:

Removing a mapping does not remove the question, the associated code list, or previously imported data.
  • You can map questions on flat and repeating forms.
  • You cannot map questions in the following form types:
    • Two-section forms
    • Drug reconciliation forms
    • Lab Forms.

      Note:

      For lab forms, study designers are required to create a 1-section repeating form and map those questions to the items in the EHR data dictionary. Lab normals do not populate these forms; instead, you must incorporate the EHR lab normal ranges and units into the form's design.
  • You can have EHR-mapped and non-EHR-mapped questions on the same form.
  • You can map text, number, date time, drop-down, checkbox, radio button, and age questions, as well as labels (for a repeating table only).

    Refer to the Data dictionary question type mapping reference guide for recommended question types and a complete list of available EHR mapping elements.

  • You can map question groups, except when used on a repeating form.
  • You can map read-only questions, but you should not use these as calculation rule targets.
  • You can map dynamic parent and child questions. For more information about dynamic questions and forms, see Define a Show Question rule and Define a Show Form rule.

    Note:

    Keep in mind, data does not import into a not-yet-triggered child question.
  • After mapping has taken place, changing a question type removes the existing mapping.
  • You can map the coding questions, which include the Verbatim term, Route of Administration, and Indication, but you cannot map coding targets—form items populated by an Oracle Central Coding dictionary—for data import. For more information, see Create the coding target fields.

Limitations

Certain EHR data elements, listed below, appear in the user interface (UI), on the Advanced side panel, under the EHR Mapping dropdown but should not be mapped to form questions. These are not active and are only present in the UI to support future enhancements to the EHR mapping feature.

Note:

For a full list of EHR data elements, see the Data dictionary question type mapping reference guide.

Table 8-2 EHR data elements do not map list

Category EHR mapping value
Labs Performing Lab
Medical History Medical History End Date
Medications Dose Original Form
Procedures Procedure Status
Procedures Procedure End Date
Vitals Respiratory Rate
Vitals Heart Rate Noninvasive

For additional information on mapping form questions, refer to the following section.