Performing Actions on Listings

You can perform various actions on data listings, including opening, responding to, and closing queries and observations, and setting and managing review statuses in Review Listings. Responding to and closing queries can also be done in query listings. Data listings created with only header fields do not support queries or observations.

Query Actions

Queries are used to track inquiries into entered data for Items and Event Dates. Query actions of opening, responding to, and closing queries can be performed either individually or in batches. The batch option allows action on up to 100 queries simultaneously. For example, 100 queries can be generated in a batch containing the same query text.

The following items are eligible for query actions:

• EDC Event Dates
• EDC Form Items
• Non-EDC Form Items

When performing query actions, you can select any cell that references a single Event Date or Form Item, including those that are part of a univariate function (for example, date format, union, and subquery). Queries are associated with the referenced Event Date or Form Item.

If a cell references more than one Item or Event Date, or doesn’t reference either, the cell details panel will not open.

Summary Links from Listings

Every listing with queries offers summary links near the top of the page. Click these links to go to the All Queries page, filtered to show only the queries created from that specific listing. Links are grouped by status: Open, Answered, and Closed.

Quick Queries

A quick query is a standardized message that can be used by data managers and sites when creating and answering queries. Quick queries simplify the querying process by offering a streamlined option to confirm data values as entered while still allowing for custom messages. Quick queries support both individual and batch manual query creation and automated creation with CDB Checks.

Opening a Query

You can create two types of queries: quick queries (confirm value) or custom queries. The custom option allows you to enter custom text, while quick queries provide a standardized message. You can also add custom text to the quick query standardized message.

To open a single query:

1. Navigate to the listing.
2. Click the Cell where you want to open a query.
3. Click Create Query in the Cell Details panel.

4. Choose the Query Type (Custom or Confirm Value).

5. For the Custom query type, enter the message in the text field. For the Confirm Value query type, you can leave the standardized message unchanged or edit the text.
6. Click Save.

To open queries in a batch action:

1. Navigate to the listing.
2. Select the Checkboxes for the rows you want to query.
3. Optional: To select all rows on the current page, select the Select All checkbox.
4. Click the Queries dropdown and select Create.
5. From the Create Query on dropdown menu in the Cell Details panel, select the column that you want to create a query on.

6. Choose the Query Type (Custom or Confirm Value).

7. For the Custom query type, enter the message in the text field. For the Confirm Value query type, you can leave the standardized message unchanged or edit the text.
8. Click Submit.

Responding to a Query

You can respond to queries on EDC and third party data with a message. Your response displays in the Query Details and Cell Details panel, as well as the Last Message column of the listing. Query messages are displayed in chronological order, from oldest to newest.

To respond to a query:

1. Navigate to the listing.
2. Click the Cell containing the query.
3. Click Answer Query.
4. Enter a message.
5. Click Save.

The system adds your query message to the query.

Closing a Query

Once a system or manual query is resolved, you can close queries on EDC and third party data from the Cell Details panel. Note that you can’t close a query when the related data Item or Event Date is locked.

To manually close a query:

1. Navigate to the listing.
2. Click the Cell containing the query.
3. Optional: Enter a message.
4. Click Close.

To close multiple queries in a batch action from a data listing:

1. Navigate to the listing.
2. Select the Checkboxes for the rows containing queries you want to close.

3. Optional: To select all rows on the current page, select the Select All checkbox.

   

4. Click Queries > Close. This opens the Close Query panel.

   

5. For Close Query on, select either the Event Date or the Item that you want to close queries on.

   

6. Optional: Enter a query message in Message Details.

   

7. Click Close.

Observation Actions

Before generating a query, discrepancies must be reviewed by the data management team and/or discussed across various teams. Observations allow data managers to collaborate with colleagues before generating queries.

You can create observations on Form Items, single-function Form Items, and Event Dates using EDC or third party data. Observations are visible wherever the Item is displayed, so the observation follows the data in all the listings where the data appears. This applies to Core, Review, and Custom data listings.

An observation decoration appears in each cell that contains at least one associated Open or Pending observation. Observations remain in the listing even if the cell value changes.

To manage all observations in one place, use the Observations page

Viewing Observations in Workbench

You can view all observations and observation messages on the Observations page. You can also filter and sort observations and navigate to the listing where the observation was created via the Observation Details panel.

To view all observations in a study:

Select your Study from the Studies page. Then, open the Observations page either from the Navigation Drawer or the Study menu.

Observations in the Observation Details Panel

You can work with individual observations in the Observation Details panel. To open the Observation Details panel, click the observation you want to view. To close the panel, click Close (x) or click the observation a second time. You can also drag the top edge of the Observation Details panel to resize it.

To navigate to the listing where the observation was created from the Observation Details panel, click the link in the Origin field.

Summary Links from Listings

Every listing with observations offers summary links near the top of the page. Click these links to go to the All Observations page, filtered to show only the observations created from that specific listing. Links are grouped by status: Open, Answered, and Closed.

Observation Statuses

Each observation can have the following (3) statuses: Open, Pending, or Closed. These statuses indicate which actions have been taken and what still needs to occur on an observation. When both Open and Pending statuses are present, the observation is considered outstanding.

Status	Decoration	Meaning
Open		Open indicates that an observation has not been addressed. This is the status assigned to all newly created observations.
Answered		Pending indicates that an observation has received a response.
Open & Pending		When both Open and Pending statuses are present, the observation is outstanding.
Closed	- -	Closed indicates that an observation requires no further action or discussion.

Observation Decorations

Observations are highlighted with decorations at both the row and cell levels. Row level decorations are located in the Review column. When hovering over a decoration at the row level, a tooltip appears if the record contains at least one open, pending, or outstanding observation (with a status of Open or Pending). A tooltip also appears in the individual cell linked to the observation when hovering over the decoration. Decorations are not displayed for observations in the Closed status, but they are still visible in the details panel.

Creating Observations

You can create an observation individually or in a batch action. Creating an observation moves it to the Open status.

To create an observation individually:

1. Navigate to the listing.
2. Click the Cell where you want to create an observation.

3. From the Observations tab, click Create Observation.

4. Choose a category from the dropdown menu (Mismatch, Out of Range, or Unexpected).

5. Enter your observation details.
6. Click Save.

To create multiple observations in a batch action:

1. Navigate to the listing.
2. Click Observations in the upper-right navigation bar.

3. Choose a category from the dropdown menu (Mismatch, Out of Range, or Unexpected). Your selected category is displayed above the listings.

4. Click the Cells where you want to create an observation.

5. Click Apply.
6. Enter your observation details.
7. Click Submit.

Assigning Observations

Users with View All Listings and View Observations permissions can be assigned to an observation. Assigning observations allows for tracking multiple reviews, questions between colleagues on a data item, or other collaboration.

To assign a user from the Observations page:

1. Click the Row containing the observation.
2. From the Observation Details panel, click Reply > Assign.
3. Select the user’s name from the Assign dropdown menu.

4. Enter a message in the Message field.

5. Click Save.

Responding to an Observation

You can respond to an observation in the Observations tab. Responding to an observation changes the status to Open or Pending, depending on your selection.

To respond to an observation:

1. Navigate to the listing.
2. Click the Cell containing the observation.
3. Click Reply.
4. Optional: Set the status of the observation to Open or Pending.
5. Enter a message.
6. Click Save.

Closing an Observation

You can close an observation individually or in a batch action. Closing an observation moves it to the Closed status. Observations can be closed when Open or Pending.

To close an observation individually:

1. Navigate to the listing.
2. Click the Cell containing the observation.

3. Click Close.

4. Optional: Enter a message.
5. Click Save.

To close multiple observations in a batch action:

1. Navigate to the listing.
2. Click the Cells containing the observation.
3. Click Close.
4. Optional: Enter a message.
5. Click Save.

Exporting Observations

You can export all observations and observation messages in your study as a CSV file. The CSV file contains the same columns as the observation listing, and any sorting or filters you apply in the listing also apply to the exported list.

To export observations:

1. Navigate to the Observations page for your Study.
2. Click the Title of the observation listing you want to export.

3. From the Observations menu, select Generate CSV.

4. To download the CSV file, refresh the page and click the Download CSV icon () at the top right of the page.

Review Listings

All query actions can also be performed in Review Listings, which provide an additional layer of query review. You can set and view record statuses and provide reasons for each status. A row’s status can be set individually or in batches and filtered by review and query status. Statuses include In Progress, Reviewed, Unreviewed or as having a Known Discrepancy.