Link subjects for Electronic Health Record (EHR) data import

With just a few clicks, you can link a subject to their Medical Record Number (MRN) in preparation to import their EHR data, removing the need for redundant data entry.

Before you can link a subject, the sponsor must complete the following tasks:

• Enable the study for EHR data import. For more information, see Enable Electronic Health Record (EHR) data import.
• Map the site to the EHR connector. For more information, see Manage your EHR site connections. As a result, Link EHR Patient and Remove EHR Link are available under Manage Subjects on the Subjects page.

To link subjects to their MRN, you must be assigned the Link and Unlink Subject with EHR Patient permission.

Follow these steps to link a new or existing subject to their MRN, unlink a subject, or address an incorrectly linked subject.

Note:

You are required to provide the subject's MRN during the linking process.

1. Link a new subject.
   1. Make sure you're on the Subjects page.
   2. Filter your view based on the required criteria. For more information, see Filter subjects in a study.
   3. Select Add Subject. For step-by-step instructions, see Add and screen a subject.
      The Add Subject dialog window opens.
   4. If you want to link the subject, enter the subject's Medical Record Number (MRN), then select Next. If you do not want to link them, select Add Subject.
      For linked subjects, the full name, date of birth, gender, city, and state are displayed.
   5. Select Add Subject.
      The Subject History sidebar displays Linked to EHR along with the associated date and time.
   You can import EHR data once you've linked your subject. For more information, see Import Electronic Health Record (EHR) data.
2. Link an existing subject.
   1. Make sure you're on the Subjects page.
   2. Select the checkbox to the left of the subject you want to link.
   3. From the Manage drop-down, select Link EHR Patient.
      The Link EHR Patient dialog window opens.
   4. Enter the subject's MRN and select Next.
      The full name, date of birth, gender, city, and state of the linked subject are displayed.
   5. Select Link.
      The Subject History sidebar displays Linked to EHR along with the associated date and time.
   You can import EHR data once you've linked your subject. For more information, see Import Electronic Health Record (EHR) data.
3. Unlink a subject.

   Previously imported EHR data remains in the study if you unlink a subject. If necessary, you can clear or delete it. You can also modify imported data, as long as you are assigned to a study role that includes the Manually Update EHR Imported Data permission.

   1. Make sure you're on the Subjects page.
   2. Select the checkbox to the left of the subject you want to unlink.
   3. From the Manage drop-down, select Remove EHR Link.
      The Unlink EHR Patient dialog window opens, asking that you confirm the action.
   4. Select Confirm.
      The Subject History sidebar displays Unlinked from EHR along with the associated date and time.
4. Address an incorrectly linked subject
   1. Follow the steps above to unlink the subject.
   2. Did you import any EHR data when the subject's link was incorrect? If so, you can manually clear that data.
   3. If applicable, follow the steps above to link a new or existing subject.

Review the following section to learn how events affect a linked subject.

• How do subject events affect a linked subject?
  Learn how Oracle Clinical One Platform subject events like screen fail, subject transfer, and subject lock impact a subject linked for EHR data import.