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Roadmap: Reviewing at the patient, visit, form, and item level

Performing a review at the patient, visit, form, or item level is a manual process tracked on the Patient Summary page by manually applying statuses to visits and forms. A sponsor user, typically the clinical data manager or medical monitor, performs this action.

Note: A reviewer can review any patient, visit, form, or item at any time, even if it is not complete.

Roadmap for reviewing at the patient, visit, form, and item level

Step

Action

Description

1

Review the data.

Data review is a manual task. Status icons appear at the patient, visit, form, and item levels to guide reviewers through the review process.

  1. Select Patients (Patients icon. Click to navigate to the Patient List page.).
  2. Click the Summary link for the patient.
  3. In the Visits navigation tree, select the patient, visit, form, or item to review. You can select multiple checkboxes.
  4. Select the status icon corresponding to the status to apply.
  5. Click Submit.

2

Issue queries.

  1. Select Patients (Patients icon. Click to navigate to the Patient List page.).
  2. Click the Summary link for the patient.
  3. Select the checkbox for the patient, visit, form, or item. You can select multiple checkboxes.
  4. Click the Create Query icon (Manual status icon. Click to create a query.).
  5. From the Query Selection drop-down list, select the query to issue.
  6. To write your own query, select Other from the Query Selection drop-down list and type the query in the Other Text box.
  7. Click Submit.

Note: You cannot issue a query on any object in the Locked status.

3

Mark the patient, visit, form, or item as reviewed.

  1. Select Patients (Patients icon. Click to navigate to the Patient List page.).
  2. Click the Summary link for the patient.
  3. In the Visits navigation tree, select the patient, visit, form, or item to review. You can select multiple checkboxes.
  4. Click the Mark Reviewed icon corresponding to the type of review.

Note: If changes are made to a form after the review is completed, the OutcomeLogix application applies the Unmarked status.

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