EHR data import requirements and considerations

If EHR data import is enabled for a study, site users can import EHR data into Clinical One Cloud Service forms, which can save site users time and improve data quality by reducing data entry mistakes.

Prerequisites

Before you can import data, the following tasks must be completed:

1. The sponsor enabled the study for EHR data import. For more information, see Enable Electronic Health Record (EHR) data import.
2. The study designer mapped form questions to EHR data elements. For more information, see Map form questions for EHR data import
3. The sponsor mapped the site to its EHR connector. For more information, see Manage your EHR site connections.
4. The site user linked the subject to their Medical Record Number (MRN). For more information, see Link subjects for Electronic Health Record (EHR) data import.

Required permissions

Users assigned to a study role that includes the Edit Form Data for Subjects permission can import EHR data. If a user needs to edit EHR data after import, the study role needs to include the Manually Update EHR Imported Data permission.

Things to know about importing data

• Imported data undergoes the same validation as manually entered data, ensuring data integrity.
• The data classification rules, defined in Clinical One Cloud Service, determine the EHR data presented to the user.
  • If a user cannot see a hidden question in the study, the associated EHR data is not presented to them and is not available for import.
  • If the user has the required data classification permissions to view/edit the hidden question, then they can import the EHR data.
• Data import is not available for a locked or frozen subject, visit, form, row, or question.
• You can import EHR data to read-only questions.
• EHR values intended to trigger dynamically hidden questions or forms are available for import.

  Note:

  Importing data for a child question is not possible if the value for a parent question hides it.
• If an EHR value does not match the study design, for example, an option defined in a code list, the data is not imported.