Clean Patient Tracker

Data managers need to provide complete and clean patient data throughout the lifetime of a study. Today study teams use Excel or custom solutions to pull data together then manually mark subjects that are deemed clean and ready for lock. This process is time consuming, limited and prone to errors. With the Clean Patient Tracker, you can track the cleanliness of Subjects and take direct action on data management cleaning activities.

CDB includes a subject-centric page, the Clean Patient Tracker, for data managers to review the cleanliness of each patient. You can filter the grid by cleaning activities and study meta data such as site, country, cohort etc. You are able to quickly take action on a subject such as reviewing and closing answered queries.

Prerequisites

Required Permissions

Users with the CDMS Lead Data Manager and CDMS Data Manager standard study roles can use the clean patient tracker by default. For users with custom study roles, your role must grant the following permissions:

Type Permission Label Controls
Functional Permission Workbench Tab

Ability to access and use the Data Workbench application, via the Workbench tab
Functional Permission View All Listings

Ability to view all listings

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

Accessing the Clean Patient Tracker

The Clean Patient Tracker is under the Subjects tab in CDB.

You can access this page from either the Study menu () on the Studies page or from the Navigation Drawer () after you’ve selected a Study.

About the Clean Status

There is a Clean column in the listing, which can show true, to indicate a clean subject, and false. A Subject enters the Clean status when the following conditions are met:

  • All Queries are in the Closed status.
  • All runs for Checks are completed. This means that all checks ran successfully, and there were no invalid checks (for example, due to an invalid CQL statement).
  • All required SDV is completed.
  • All terms are coded.

Viewing Subject Information

Columns

The Clean Patient Tracker includes the following columns:

Column Description
Subject Name The Subject ID (Name) of the Subject. Clicking the value in this column opens the subject’s Casebook in the Review tab of Vault EDC.
Subject Status The Status of the Subject
Country The Study Country of the Subject
Arm The Arm the subject is assigned to. If there is no assigned Arm, this column is blank.
Cohort The Cohort the subject is assigned to. If there is no assigned Cohort, this column is blank.
Site The Site assigned to the Subject
Latest Event The latest Event (Visit) for the Subject
Overdue Events The number of Events in the Overdue status for the Subject (scheduled, incomplete Events where the Planned Date is earlier than the current date)
Incomplete SDV The total count (number) of Forms and Event Dates that are SDV Required and incomplete
Open Queries The total count (number) of Queries in the Open status. Clicking the link in this column opens a query listing of these queries in the Queries page of CDB so that you can take action on those open queries.
Answered Queries The total count (number) of Queries in the Answered status. Clicking the link in this column opens a query listing of these queries in the Queries page of CDB so that you can take action on answered queries.
Uncoded Terms The total count (number) of coding forms where the Coding Status is Open, Uncoded, Rejected, Noncurrent, or Updated.
Incomplete Checks This column shows the number of Checks that didn’t run as scheduled for the Study. If the Study has at least one Check that is scheduled to run hourly and didn’t run as scheduled, this column shows (for every subject) the total number of checks that need attention. Reasons for incomplete checks include a missing third party source, a missing third party data package, or a study design change. Once the Check is modified to accommodate the change and runs successfully, this column updates accordingly. See Automating Queries with Checks for additional details.
Clean This column shows “true” when the subject is clean. When the subject isn’t clean, this column shows “false”.
Summary This column shows signed, frozen, and locked statuses.

Filter by Site

You can filter the list of subjects by Site. The filter shows a count of the Subjects assigned to a Site. In the Filters panel, click a Site to show only Subjects assigned to that Site.

Click Close () to close the Filters panel. Click Filter to reopen it.

Sort & Filter the Subjects Grid

You can easily sort and filter subjects using the Sort & Filter menu. To open the Sort & Filter menu, click the column header for the column you want to sort by or apply a filter to.

If a column already has a sort or filter applied, Workbench shows the Sort icon ( for ascending or for descending) and the Filter icon (filter_list). You can click these in the Column Header to edit the sort or filter. You can also sort and filter columns that don’t already have a sort and filter.

How to Sort

You can sort by a single column using the Sort & Filter menu.

To sort by a column:

  1. Locate the column you want to sort by in the datasheet.
  2. If the column doesn’t already have a sort or filter applied, hover over the Column Header to show the Filter icon (filter_list).
  3. Click the Filter icon (filter_list). This opens the Sort & Filter menu.
  4. Under Sort by, select Ascending (A to Z) or Descending (Z-A) for a sort order.
  5. Click OK. Workbench sorts the datasheet by the column values in the chosen sort order. Workbench shows a Sort icon ( for ascending or for descending) in the column header.

How to Reset a Column’s Sort Order

To reset (remove) the sort and return the listing to the default order, open the Sort & Filter menu and click Reset.

Reset the sort order

How to Filter by a Column

You can also filter your list of subjects using the Sort & Filter menu. You can select a comparison operator and, if required, a value to filter by, and use them as a filter.

To filter your listing with a conditional filter:

  1. Locate the column you want to filter by in the datasheet.
  2. Hover over the Column Header to show the Filter icon (filter_list).
  3. Click the Filter icon (filter_list). This opens the Sort & Filter menu.
  4. Under Condition, select an Operator. Workbench uses the entered Value and chosen Operator to compare the values within the column. There are different operators available for different column data types.

  5. If required, enter a Value compare values against. Note that you can only use a static value and not a function. For dates, use YYYY-MM-DD. Filter condition, in enrolled__v

  6. Click OK. OK button

The following comparison operators are available for filtering. Note that the available operators are limited by a column’s data type.

  • AND: Logical AND
  • OR: Logical OR
  • =: Equals
  • !=: Does not equal
  • >: Greater than
  • <: Less than
  • >=: Greater than or equal to
  • <=: Less than or equal to
  • IS: Tests a value against a boolean condition
  • IS NOT: Tests a value against a boolean condition
  • IS NULL: Tests a value against a NULL
  • IS NOT NULL: Tests a value against a NULL
  • IN(): Check whether a value is within a defined set of values
  • BETWEEN...AND...: Check whether a value is within a range of values
  • CONTAINS: Check whether a value is contained within the value
  • DOES NOT CONTAIN: Checks whether a value is not contained within the value

Generate a CSV

You can generate a CSV file of the Clean Patient Tracker. Any filters applied in the UI will also apply to the CSV output.

To generate a CSV:

  1. Navigate to the Clean Patient Tracker.

  2. From the Subjects menu (), select Generate CSV.

  3. Save the CSV file.