5 Review and Manage Data

Data can be reviewed using the Subject Matrix or the Queries page. Each of these review options is outlined below. Monitors also have the option of reviewing data using the Source Data Verification page.

Review and Manage Data from the Participant Matrix

Typically, Monitors and Data Managers are responsible for reviewing data, but anyone with access to the Participant Matrix can view/review data as needed. Data Managers can also remove a participant and/or reassign a participant to a different site. The actions column presents the appropriate actions available, based on your user role. The following displays the actions available to a Data Manager:

Remove a Participant

Data Managers have access to remove Participants. Removing a Participant does not delete the Participant, but instead removes access to that Participant's data. The data for that subject can still be viewed, but cannot be edited and will not be included in data extracts. Once a Participant is removed from the study, the remove icon changes to a restore icon. To restore access to that Participant's data, simply click the restore icon and the data is available again for editing and extracts. 

Reassign a Participant

Data Managers also have access to reassign a Participant to another Site. This may be needed if a Participant moves to a different location but still wants to continue on the Study. Prior to reassigning, be sure that the original Site has an extract of that Participant's data. Then, to Reassign a Participant, click the Reassign icon. Specify the new site and click Reassign Participant.

The new site has immediate access to that Participant's forms and all data previously collected for the Participant. The original site no longer has access to that Participant's ongoing data.

Review Participant Data

To review data, click the view icon for the participant whose data you'd like to review.

The participant detail page displays. All visit-based events are listed first, followed by all common events.

To review data on a specific form, click the view icon for that form.

Filter Participant Details

As you review data, you can enter search criteria for the Common Events - for example, to show only AEs that are ongoing. You can also change the number of rows listed for any of the Common Events, and you can sort Common Events by clicking the toggles next to any of the column headings. When you customize anything related to what is displayed for Common Events, the Custom View On button displays at the top of the Participant Detail page.

The Custom View is active for that participant throughout the time you are logged into OpenClinica. If you view a different participant's detail page, the view may not be customized, or if it is, it may be a different customization. In the example above, throughout the current session, any time you view participant 001, that same custom view is in effect.

To clear a custom view, click anywhere on the Custom View On button and all view customizations are removed for that participant.

Create Queries

As you review data, if you need more information from the site for a particular item, click the bubble icon next to that  item to create a query.

To create the query:

  1. Type the query in the Comment box.

  2. The system automatically assigns the query to the person who entered the data, but you can select a different user from the drop-down list if you'd like.

    Even if you assign a query to a specific user, anyone with access to that participant's data can respond to the query. For example, if you assign it to a CRC at a site, that query would be on that CRC's to-do list, but any other user at that site who has access to OpenClinica could respond to the query.

  3. To email the assigned user to make him/her aware of the query, check the Email box.

    The email includes a link to log into OpenClinica; no study data is referenced in the email contents.

  4. To save and assign the query, click Submit.

Note that the item history is tracked in the lower portion of the query dialog box.

Continue to review and query data as needed.

The color of the query bubble represents the query status, as follows:

Status Bubble Appearance Comments
No Query   Click this bubble to create a query.
New   A query has been added by either a site user (e.g., a comment/annotation), data manager, or monitor, or was auto-generated by OpenClinica based on built-in edit checks.
Updated Either a site user, data manager, or monitor has added information to the query.
Closed   The query is considered resolved by the data manager or monitor.
Closed Modified   Slightly paler than Closed, this means the data was changed after the query was closed

 

Review and Manage Data from the Queries Page

To review and manage data from the Queries page, from the Tasks menu, select Queries.

The Queries page displays. There is a summary table followed by a detalied list of queries that is filtered to display Queries only. To see entries for Reason for Change, click the gray filter box under the Type column and select Reason for Change (see Marking a Form Complete). You can filter the Queries view to filter any column that includes a gray filter box.

 

Details about each query are listed in the detail section of the page. You have options above the table that allow you to show more columns (Show More), download the queries, or print.

To review data associated with a query, you have two options:

  • View Query Only: This option displays a shaded background showing the item value in question, with the query and item history in the foreground. You can add a query comment, assign the query, and you have the option of emailing the assigned user. All users with access to queries can update the query; only Data Managers and Monitors have access to close a query.

  • View Query Within Record: This option displays a shaded background of all the item values on the form for that query. You have access to update the query and update and/or review all the data on the form. This provides reviewers with more context when reviewing specific item data issues.

You can then update the query comment, use the x to close the query details, and review the entire form in question. Data Managers and Monitors have the additional option of closing the query.

If an item only displays based on the response to another question, there may be instances where an item was conditionally displayed, a query was added to that item, and then the response to the lead-in question was changed, so that item is no longer displayed. That query still exists, however, and needs to be addressed. Similarly, if there is a form that has repeating records and a query was added to a row, but that row has since been deleted, the query still exists, but is no longer displayed on the form. OpenClinica informs you of these hidden items and provides an option for resolving the associated queries.

For example, when the item in question is a response that has since been hidden, or is on a repeating record that has since been deleted, the following message displays: