Import Electronic Health Record (EHR) data

Site users can now import EHR data into Oracle Clinical One Platform studies leveraging the Oracle Clinical Connector (OCC).

Previously, clinical trial coordinators and researchers spent valuable time manually reentering subject data from an EHR system into an Electronic Data Capture (EDC) system like Oracle Clinical One Platform. This manual process, which involved duplicate data entry, increased the chance of data discrepancies, creating additional work, and increased costs.

When enabled for a study, OCC allows site users to easily import EHR data directly into Oracle Clinical One Platform forms for new and existing subjects, improving efficiency and data quality.

OCC connects to various EHR systems to extract and normalize patient data, creating a single record for each subject.

After enabling a study, mapping the questions, associating a site with a connector, and linking subjects, a site user can open a visit and select Import EHR Data. Once selected, OCC establishes a connection with Oracle technology Health Data Intelligence (HDI) to obtain the EHR data for questions mapped during study design. The system presents the data to the user for selection before automatically importing it.

Before you work with this feature

Global user managers and site user administrators should be aware of three new permissions, as well as one existing permission that has some additional capabilities.

Permission	Type	Details
View EHR Connectors (New)	Global	This global role allows sponsor users to view the Oracle-created connectors on the EHR Connectors tab under Global Settings.
Create and Manage Sites (Existing)	Sponsor	In addition to the ability to create and manage sites, this permission now enables sponsor users to select a connector from the EHR Connections setting for participating sites. You can do this on the Sites & Labs tab under Study Settings.
Link and Unlink Subject with EHR Patient (New)	Site	Allows site users to link a subject number to the subject's Medical Record Number (MRN), making it possible to import their Electronic Health Record (EHR) data.
Manually Update EHR Imported Data (New)	Site	Allows site users to update, delete, and clear Electronic Health Record (EHR) data after import.

How it works

Contact your Oracle point of contact for more information if you wish to integrate your study with OCC. In the meantime, here's a brief overview of the process:

A sponsor decides they want to enable OCC for a study and reaches out to their Oracle point of contact.
Oracle onboards participating sites in HDI and creates the necessary connectors in OCC.
The Oracle Clinical One Platform site administrator maps each site to their connector.
During the study design period, the study designer maps the relevant questions to the appropriate EHR data dictionary element.
Site users link subjects (new and existing) to their Medical Record Number (MRN).
For linked subjects, a new button called Import EHR Data is available. When selected, the system presents the subjects' EHR data. The user chooses which data to import, and upon selecting Submit, the system automatically populates the questions.

Note:
The same validation checks apply to imported data as they do to manually entered data.

Details for sponsor users

You can easily view a list of Oracle-created OCC connectors and establish the necessary connections between participating sites and their respective connectors. These simple steps enable new features for site users, allowing them to quickly view and import a subject's EHR data, eliminating the need for duplicate data entry.

The General tab under Study Settings displays a new label, Oracle Clinical Connector Enabled. This is the first indication that the feature has been enabled for the study.
You can view a list of available connectors on the new EHR Connectors tab, under Global Settings.
You can map your sites to their OCC connector using the new EHR Connection dropdown, located on the Sites & Labs tab.

You can find additional information in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.

Details for study designers

A few extra steps in the design phase can result in more efficiently designed studies and downstream benefits for site users and subjects. Easily map form questions to elements in an Oracle-managed data dictionary and use new pre-seeded code lists to ensure successful data import and minimize data cleaning.

You can find a new setting named EHR Mapping under the Advanced sidebar when adding or editing form questions. This setting allows you to map form questions to EHR data dictionary elements. Below is a partial list of the EHR data dictionary categories and elements. A complete list will be available in the Study Designer User Guide, under the title Data dictionary question type mapping reference guide, after the Release Assessment Environment (RAE) upgrade.
- Demographics: Birth Date, Birth Sex, Ethnicity, and Race.
- Labs: Lab Test Name, Lab Result, and Lab Result Units.
- Vitals: Body Height, Body Weight, BMI, Body Temperature and the associated units and dates of collection.
- Medications: Medication Name, Medication Dose, and Medication Dose Units.
- Medical History: Medical History Diagnosis, Medical History Start Date, and Medical History Status.
- Procedures: Procedure Name and Procedure Start Date.
You can access new EHR code lists (available in English only) by selecting Code List during the question creation and mapping process. These custom code lists are mapped to the EHR data dictionary and include lists for race, sex, ethnicity, and units, to name a few.
During major releases, Oracle Clinical One Platform adopts updated versions of the data dictionary and associated code lists. This ensures that your EHR-enabled study uses the latest EHR data dictionary.
The EHR mapping feature is available for your library studies, so you don’t have to recreate the mappings each time.

You can find additional information in the Study Designer User Guide after the Release Assessment Environment (RAE) upgrade.

Details for site users

With just a few clicks, you can link a subject to their Medical Record Number (MRN), then import their EHR data, removing the need for redundant data entry. You can even re-import data repeatedly, guaranteeing the most accurate data for your subjects.

Note:

You do not need to link all subjects in a study. You determine which subjects to link.

For OCC-enabled studies, you must provide the subjects' MRN when linking new or existing subjects.
- For new subjects, the process begins by linking their Oracle Clinical One Platform subject number to their MRN. This is referred to as Subject-Patient linking and has been seamlessly added to the add subject process.
- For existing subjects, select the new Link EHR Patient option in the Manage Subjects drop-down. Additionally, you can remove a Subject-Patient link by using the new Remove EHR Link option, also available in the Manage Subjects drop-down.
The Import EHR Data button becomes available on the Subject Visit screen after you link a subject. When you select it, the system presents you with the subject's EHR data. You can then select the specific data you want to import.

Note:
The data classification rules, defined in Oracle Clinical One Platform, determine the EHR data presented. If a question is not visible in the study, then the EHR data associated with it is not available for selection and import.
Users assigned to a study role that includes the Update EHR Data permission have the ability to edit data after import if necessary.

You can find additional information in the Site User Guide after the Release Assessment Environment (RAE) upgrade.

Impact to reports, extracts, and datasets

To support this enhancement, we introduced the following reporting changes:

Report	Type of change	Description
Annotated Case Report Forms	Modified data element description	The Advanced column includes EHR Mapping and displays the data dictionary mapping values for the parent and child (if applicable). For example, EHRMapping:Birth Sex or EHR Mapping:Labs-Lab Test Name.
Sites and Depots	Modified data element description	The Attribute column, in the Site Additional Information section, includes EHREnabled and displays the EHR Connector (Health System) name under the Data column.
Study Design	Modified data element description	The Properties column, in the Forms section, includes EHR Mapping and displays the data dictionary mapping values for the parent and child (if applicable). For example, EHR Mapping:Birth Sex or EHR Mapping:Labs-Lab Test Name.
Subject Data	Modified data element description	User Name displays the logged-in user who imported the data. Date & Time indicates when the data was saved. Type of Change indicates if the data was created (initial import) or modified (subsequent imports). Value provides the imported EHR data value. Reason for Change Comment includes the following: Data Originator: Indicates the connector name plus the HDI Record ID. Date of Collection: Displayed as YYYY-MM-DD (if collected). OCC Mapped Codes: Provides the codes from the source EHR system, which are associated with the EHR mapping value selected during form design and the associated imported data value. Source Date and Converted Date: Included if the source date was converted to match the date format defined for the question in the study. For example, the source date YYYY-MM-DD is converted to DD-MMM-YYYY. Source Units and Converted Units: Included if the source unit was converted to match the unit defined for the question in the study. For example, the source unit inch is converted to cm. Source Value and Converted Value: Included if the source precision was converted to match the precision defined for the question in the study. For example, the source value 4.00 is converted to 4.0.
Subject Events	Modified data element description	The Event Type column includes Subject-patient Link Created and Subject-patient Link Removed.

To support this enhancement, we introduced the following Oracle Clinical One Analytics changes:

Dataset	Type of change	Description
Blinded Subject Event	Modified data element description	The Site Folder section includes EHR_ENABLED and displays Yes or No, indicating if a site is currently enabled for EHR data import. No is displayed if EHR has never been enabled for a site or if a site has been disabled for EHR.
Queries	Modified data element description	The Site Folder section includes EHR_ENABLED and displays Yes or No, indicating if a site is currently enabled for EHR data import. No is displayed if EHR has never been enabled for a site or if a site has been disabled for EHR. The Audit Folder section includes EHR_IMPORTED indicating if a question was populated via an EHR data import. If EHR data import is disabled after the data is imported, EHR_IMPORTED continues to show Yes.
Study Design	Modified data element description	The Study Folder section includes OCC_ENABLED and displays Yes or No, indicating if a study is enabled for EHR data import. No is displayed if your study is not currently enabled; this includes those studies that previously were. The Item Folder section includes EHR_MAPPING and displays the OCC data dictionary mapping value for a question mapped for EHR data import.
Subject	Modified data element description	The Subject (Required) folder section includes EHR_LINK_STATUS and displays Yes or No, indicating if a subject is currently linked for EHR data import.
Subject Forms	Modified data element description	The Site Folder section includes EHR_ENABLED and displays Yes or No, indicating if a site is currently enabled for EHR data import. No is displayed if EHR has never been enabled for a site or if a site has been disabled for EHR.
Subject Form Items	Modified data element description	The Site Folder section includes EHR_ENABLED and displays Yes or No, indicating if a site is currently enabled for EHR data import. No is displayed if EHR has never been enabled for a site or if a site has been disabled for EHR. The Audit Folder section includes EHR_IMPORTED, indicating if a question was populated via an EHR data import. If EHR data import is disabled after the data is imported, EHR_IMPORTED continues to show Yes.
Unblinded Subject Event	Modified data element description	The Site Folder section includes EHR_ENABLED and displays Yes or No, indicating if a site is currently enabled for EHR data import. No is displayed if EHR has never been enabled for a site or if a site has been disabled for EHR.

You can find additional information in the Reporting Guide and the Analytics User Guide after the Release Assessment Environment (RAE) upgrade completes.

Already working in a live study?

If enabled, the EHR features defined above are backward compatible for use with existing studies.

Parent topic: Data collection