2 View data listings, display data flow, and create discrepancies

This section contains the following topics:

• Choose a listing type and view data
  
• Search for data
  
• Review data
  
• Create discrepancies
  
• Export data to Excel or CSV
  
• View data flow
  
• Create a custom listing
  
• Copy a custom listing
  
• Use the Expression Builder
  
• FAQs
  

Choose a listing type and view data

You can choose different methods to view data and show records in a study. For example, you can view any of the following listings:

• Default listings
  
• Custom listings
  
• Validation check listings
  

Default listings

Default listings shows the current data in a table.

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand Default Listings in the left panel. Then, expand a clinical data model from the list.
4. Select a listing to open it.

   To locate a listing, enter part of a listing name in the Search field and click the Search icon.

Custom listings

Custom listings show records that satisfy criteria that you or others set.

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand Custom Listings in the left panel. Then, expand a clinical data model from the list.
4. Select a custom listing to open it.

   To locate a listing, enter part of a listing name in the Search field and click the Search icon.

   Tip:

   • You can choose to show disabled listings by selecting Show disabled CLs under the Search field. Oracle DMW disables listings if they read from a table that is not used in the study.
   • You may need to scroll down to see Custom Listings in the left pane.
   • To view deleted InForm data create a custom listing, but do not install it. The system displays all records that meet the criteria, including deleted records. After you install it, the deleted rows are not displayed. For details on creating a custom listing, see Create a custom listing.

Validation check listings

Validation check listings show records that include a discrepancy identified by a validation check.

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand VC Listings (Validation Check Listings) at the bottom of the left panel. Then, expand a data model from the list.

   Note:

   • To locate a listing, enter part of a listing name in the Search field and click the Search icon.

   • You can choose to show disabled listings by selecting Show disabled VCs. Oracle DMW disables listings if they read from a table that is not used in the study.
4. Select one validation check in the batch to see:

   • All records with discrepancies identified by the validation check.

   • Any other discrepancies on the records.

   If someone fixed a data item and closed the discrepancy, you cannot see the record.

Validation checks run in batches as configured in the Home page.

Search for data

You can choose different methods to search for data. For example, you can use the following:

• Find feature to search for column values
• Filters to find data and discrepancies, save filters, and use public filters

See the following procedure for details.

• Use the Find feature
  

Use the Find feature

Use the Find feature to search on column values in the current records.

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand one of the listings in the left panel (Default Listings, Custom Listings, or VC Listings). Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. Click inside the Find in Column field at the top of the table to open the Columns drop-down list.
6. Press the space bar to open the Operators drop-down list. Build the find criteria you need. For example, you can select equals (=), contains, starts with, greater than or equal to (>=).

   To enter text (string values), add single quotes around the text (for example, 'Boston').

7. Click the Apply icon to apply the find. (Click the Clear icon to clear the Find criteria.)

Review data

The following topics describe how to view discrepancies in a listing, view details, assign and remove flags, view data lineage, and reprocess discrepancies.

• View discrepancies in the Listings page
  
• Show all discrepancies on one data item
  
• View discrepancy details
  
• Assign and remove flags
  
• Show flags assigned to a record
  
• View data lineage
  
• View data in InForm or another system
  
• Reprocess discrepancies that failed to be sent to InForm
  

View discrepancies in the Listings page

If a user creates or comments on a discrepancy, the record appears with one of the following icons next to the appropriate data point:

Table 2-1 Discrepancy Icons

Discrepancy Icon	Description
	Open discrepancy on the data item. Needs attention. Discrepancies with one or more entries show with a number next to the icon. For example, you see a "2" if the data item has two discrepancies:
	Candidate for a discrepancy. Needs attention.
	Closed or cancelled discrepancy.
	Answered discrepancy. Review comments.
	Cancelled discrepancy.

You can also see a duplicate version of the discrepancy icon to the left of the row if a data item includes a discrepancy. It appears in the second column of the listing.

Show all discrepancies on one data item

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand one of the listings in the left panel (Default Listings, Custom Listings, or VC Listings). Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. Select a data item.
6. Click Details at the top of the table to open the Discrepancies panel on the right.
7. Expand Additional Information to view more details. For example, you can click View in Source to access the source of the data (if connected to InForm or another supported source). Or, click Assign Flags to assign a flag and state to the data point.

   Tip:

   To view details or act on one of the discrepancies, right-click the data item, and select Go to Discrepancies from the drop-down menu. Select one discrepancy to see its details in the lower panel.

View discrepancy details

1. After you select a study, click Data Management in the title bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand one of the listings in the left panel (Default Listings, Custom Listings, or VC Listings). Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. Select one or more data items with a discrepancy.
6. Right-click and select Go to Discrepancies from the drop-down menu. Or, click Discrepancies > Go to Discrepancies (or Show All Discrepancies to see all of them).
7. Select a discrepancy from the Discrepancies panel on the right to see details on it.

Assign and remove flags

Use flags to help track and move the data review process. You can filter by flag in the Listings and Discrepancies pages. See Flag FAQs for more details.

• Assign a flag to a record
  
• Remove a flag
  

Assign a flag to a record

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand Default Listings listings in the left panel. Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. Select the row with the record you want to flag, right-click anywhere in the row and click Assign Flags. (Or, click Flags > Assign Flags.) The Assign Flags dialog box opens.

   Tip:

   To assign the same flag to multiple records, select the records by pressing the Shift or Ctrl key while you select records.

6. In the Flags field, select the previously created flag name you want to use from the drop-down list.
7. In the States field, select the previously created state name from the drop-down list. The names are associated with a high, medium, or low flag state.
8. Click Assign. You can see the flag state in the first column of the listing (up and red for high state, sideways and yellow for medium, or up and green for low).

   Tip:

   If a data load completes while you were viewing the page, you see a prompt to refresh the page and Oracle DMW cannot assign the flag. Click the Refresh icon and check the data. If the flag still applies, assign it again.

Remove a flag

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand Default Listings listings in the left panel. Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. Select the row with the flag by clicking the arrow icon at the beginning of the row (first column).

   Tip:

   To select multiple records with flags, press the Shift or Ctrl key while you select records.

6. Right-click and select Show Flags. The Show Flags dialog box opens.
7. Select the flag you want to clear and click the Clear Flag icon on the right.

   Note:

   You cannot remove flags assigned in InForm. InForm flags use a prefix of Inf_.
8. Click OK.

Show flags assigned to a record

For each flagged record, Oracle DMW shows a colored arrow in the first column of the listings (with a flag icon header) to represent the flag with the highest priority for the record. For example, you may see any of the following arrows if the record includes a flag:

• = High priority flag

• = Medium priority flag

• = Low priority flag

To see the flags applied to a record:

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand Default Listings listings in the left panel. Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. Select the row with the flag by clicking the arrow icon at the beginning of the row (first column).

   Tip:

   To select multiple records with flags, press the Shift or Ctrl key while you select records.

6. Right-click and select Show Flags. The Show Flags dialog box opens. You can expand the flags to see details on the state or change it.
7. Click OK.

View data lineage

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand Default Listings, Custom Listings, or VC Listings in the left panel. Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. Click anywhere in the row of the record.
6. Right-click and select one of the following to open a graphical representation of the source, target, or preferred path:

   • Show Preferred Path If there are multiple source data items, one must be designated as preferred when the discrepancy is created by a validation check or a person. The system applies the discrepancy to the data items in the preferred path.

   • View Source Data to see upstream data that contributed to the selected data item.

   • View Target Data to see downstream data that the selected data item contributes to. Target data is not available in the Validation Check Listings page.

   Note:

   Click the tabs at the top of the graphic to display the source, target, or preferred path.

View data in InForm or another system

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand Default Listings in the left panel (Default Listings, Custom Listings, or VC Listings). Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. Select a data item that originated in InForm or a system connected through the generic connector.
6. Right-click and select View Data in External Source.
7. Log in to InForm or whatever EDC system the data came from.

   If the selected DMW data item has more than one source data item, the system displays the one on the preferred path.

   Tip:

   If you see a discrepancy in DMW that should have been sent to InForm or another source but wasn't, it may be that the process of sending the discrepancy to InForm failed. You can check this and fix it on the Home page. See Reprocess discrepancies that failed to be sent to InForm.

Reprocess discrepancies that failed to be sent to InForm

1. Open the Home page and click the Validation Checks tab.
2. Click the Failed to send Discrepancies icon in the upper right corner. The Reprocess Discrepancies dialog box opens.

   For each source data system, Oracle DMW displays the external system, discrepancy tag, and counts for the selected study and lifecycle stage. In the Discrepancy Tag column you see:

   • PendingForSystem shows the number of validation check discrepancies currently pending to go the system.
   • ProcessingForSystem shows the number of validation check discrepancies currently being sent to the system.

   • Failed Processing forSystem shows the number of discrepancies that should have been sent to the system but weren't.

3. If any discrepancies failed to be sent, click the Reprocess Discrepancies icon to send them again. Click the Refresh icon to see progress.
4. Click OK.

Create discrepancies

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Listings from the drop-down menu.
3. Expand Default Listings, Custom Listings, or VC Listings. Then, expand a clinical data model from the list.
4. Select a listing to open it.
5. In the appropriate row, select one or more data items where you want to create a discrepancy. (You can select multiple data items if they all have the same issue.)

   Tip:

   To select multiple data items, press the Shift or Ctrl key while you select items.

6. Right-click and select Create Discrepancy. The Create Discrepancy dialog box opens.
7. For the State, select Open (definitely a discrepancy) or Candidate (possibly a discrepancy).
8. In the Discrepancy field, enter details about the discrepancy (required). Then, fill in the remaining optional fields if necessary (Category and Action you want taken [for example, Ready to Send, Send to Spreadsheet, Needs Review]). To include a phrase set by you (for example, your name), select Append User Name.
9. Click Create. Each selected data item appears with a discrepancy icon. You can also see the discrepancy icon in the second column of the record. For details on the discrepancy icons, see View discrepancies in the Listings page.

Export data to Excel or CSV

After you select a study and open a listing, you can export the data. To export the data in a listing, click Export from the top of the listing table and select one of the following from the drop-down list:

• Export All to Excel generates an .xls file that includes all the data that satisfies the current filters (if any used).

• Export All to CSV generates a comma-delimited text file that includes all data that satisfies the current filters (if any used).

View data flow

The data flow diagram shows how clinical data models map to each other. It shows an image of the input model and how the data flowed to the target model (successfully, with errors, or with warnings). This helps you locate areas you may need to troubleshoot.

For more details on viewing the data flow, see this video:

1. After you select a study, click Data Management in the navigation bar.

   Note:

   To display the data flow, select a study with 25 data models or less. (See Select a study for details on selecting a study.)
2. Click Data Flow from the drop-down menu.
   You see a diagram showing the data flow. The width of the flow paths are proportional to the flow rate. For example, you may see something similar to this:
3. Review the color of the flows to determine if the data loaded successfully (green path), includes errors (red path), includes warnings (yellow path), or shows light gray (job not submitted).
4. Click on a data model in the data (dark gray, vertical bars) to see more details on the status. For example, if you click the data model with the area you want to inspect, a dialog box opens with details on the data load, date of the last data load, and next expected run time for the model:
   

   Note:

   Depending on the amount of details shown, you may need to use the vertical and horizontal scroll bars to see all the content (if available). And, if the system finds errors (for example, failures when loading data into the data model), the dialog box includes a link to the log file.
5. If you opened a dialog box on a data model, you can do one of the following:
   • Click Go to Listings to open the Listings tab and review the data in the appropriate listing.
   • If available, click Log to download the log file and see details on the errors.
   • Click anywhere in the Data Flow Diagram title bar to close the dialog box.
6. Click any main menu button in the navigation bar to exit the data flow diagram.

Create a custom listing

You can create a custom listing and define the access, columns displayed, table aliases, and data conditions. See this video for details:

This section contains the following topics:

• Define query details
  
• Select columns to display
  
• Select packages
  
• Define table aliases
  
• Specify and test criteria
  
• Save and install a custom listing
  

Define query details

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Custom Listing Manager from the drop-down menu to open the Custom Listing Manager tab.
3. Click the Add icon from the Custom Listings header in the left panel to open the Add Custom Listing dialog box.
4. Enter the appropriate information for the new custom listing in the Name and Description fields.

   Tip:

   Use a name with 25 characters or less to avoid scrolling to see the full name.

5. Select Authorize access to this listing for users without Blind Break rights if you know that the listing only displays non-blinded data, even though at least one source table contains blinded data. Take care to select columns that do not contain blinded data.

   If any source table is blinded in any way and this setting is not selected, the system blinds the entire target table, so that only users with Blind Break privileges can view any data.

6. Select Mark as Public to enable all data reviewers to use this custom listing.
7. Do one of the following:
   • Continue on to Select columns to display to continue defining your custom listing.
   • Click OK to close the dialog box and save the custom listing with the details you entered. You can return to this procedure and search for it to continue defining it later.

Select columns to display

Identify the columns to display in the listing and write an expression to change data display (if needed, for example, to mask blinded data, or to append a string to all values in the column, or to concatenate two column values in a single column).

1. If not done already, open the custom listing you created in Define query details.
2. Click the Selected Columns tab. Then drag the tables or columns you want to display from the Source panel into the Selected Columns tab.

   Tip:

   To select multiple columns, use Ctrl+click or Shift+click.

   Tables and columns that are marked Not Used in the transformation that writes to this model are not displayed here.

3. If you need an Expression to operate on a column(s) to affect the way data is displayed, you must create a three-character Table Alias for its source table in the Define table aliases tab, then select it from this drop-down list.

4. Enter the Column Header for Display in the Custom Listings page.

5. Enter a Sort Order number to determine the column's display order relative to other columns.

6. Select Ascending (ASC) or Descending (DESC) Sort Type for the data display.

7. If you need an Expression to operate on the column in the SELECT clause, do one:

   • Enter the expression in the Expression field.

     If you need to use a function and you write the expression in free text, open the Select Packages tab and select the packages you will use. This enables the system to generate the query code.

   • Click the Icon shows letters and a pencil.

     Modify Expression icon to Use the Expression Builder. You can edit code generated by the Expression Builder in this field afterward.

   To write an expression that operates on multiple columns, add all columns in the expression to the same row in the Selected Columns tab:

   1. Add one column to Selected Columns and highlight it there.

   2. Select the additional column(s) in the Source pane and click the Use in Expression icon in the Source pane.

      Note:

      If you select a column that contains masked data, write an expression for the column to mask values.

8. If necessary, use the following icons in the table toolbar to do the following:

   • The Select Table Alias icon opens a Select Table Alias dialog box. You can use the drop-down list to assign an alias to the selected column. Click OK when done.
   • The Reorder Columns icon opens the Reorder Columns dialog box. You can select a column and click the appropriate arrows to change the order. Click OK when done.
   • The Delete Column icon deletes the selected column.
   • The Detach icon detaches the table from the page for you to see the whole table. Click X in the upper-right corner to close it.
9. Do one of the following:
   • Continue on to Select packages to continue defining your custom listing.
   • Click OK to close the dialog box and save the custom listing with the details you entered. You can return to this procedure and search for it to continue defining it later.

Select packages

Identify the packages of functions (for example, static functions that you defined in the study configuration) that you want included in the listing.

1. If not done already, open the custom listing you created in Define query details.
2. Click the Selected Columns tab to open the list of packages you their path that you can add to the custom listing.
3. In the Select column, select the packages you want. You can choose one of the following:
   • Leave the drop-down field over the Select column set to All.
   • Select the packages you want to include and click Selected. The custom listing only includes the package you selected.
   • Select the packages you do not want to include select and click Not Selected. The custom listing only includes the packages you did not select.

4. If necessary, use the following icons in the table toolbar to do the following:

   • The Idle icon holds the packages loading.
   • The Clear Filter icon clears a filter.
   • The Query by Example icon opens fields at the top of each column for you to enter the name, description, or path to locate it.
   • The Detach icon detaches the table from the page for you to see the whole table. Click X in the upper-right corner to close it.
5. Do one of the following:
   • Continue on to Define table aliases to continue defining your custom listing.
   • Click OK to close the dialog box and save the custom listing with the details you entered. You can return to this procedure and search for it to continue defining it later.

Define table aliases

Table aliases are required only if you are using a self-join or writing a SELECT expression on a table column.

1. If not done already, open the custom listing you created in Define query details.
2. In the Define Table Alias tab, select the table from the drop-down list.
3. Enter an alias. Use an alias with three characters or less.

   The system displays the alias in the Selected Columns tab.

4. If necessary, click View to access options to see all or specific columns, detach the table, sort, or reorder columns. (For more details on customizing the view, see Customize the user interface display.) You can also use the following icons in the toolbar to do the following:
   • The Delete Column icon deletes the selected column.
   • The Add Table Alias to add another alias.
   • The Remove Table Alias icon deletes the alias.
   • The Detach icon detaches the table from the page for you to see the whole table. Click X in the upper-right corner to close it.
5. Click OK.
6. Do one of the following:
   • Continue on to Specify and test criteria to continue defining your custom listing.
   • Click OK to close the dialog box and save the custom listing with the details you entered. You can return to this procedure and search for it to continue defining it later.

Next: Specify and test criteria.

Specify and test criteria

Specify the data condition the listing will look for.

1. If not done already, open the custom listing you created in Define query details.
2. Select the Criteria tab.
3. Build the WHERE clause to determine which records appear in the listing. Click the Add or Modify Criteria icon and Use the Expression Builder.
4. In the custom listing Query Details pane, view and test the generated code:

   • Click View Source. The system generates and displays the PL/SQL code.

   • Click Test: The system generates PL/SQL code, validates it, and displays either an error message or the records retrieved.

5. Do one of the following:
   • Continue on to Save and install a custom listing to continue defining your custom listing.
   • Click OK to close the dialog box and save the custom listing with the details you entered. You can return to this procedure and search for it to continue defining it later.

Save and install a custom listing

1. In the Custom Listings panel, select the listing you created.

   Note:

   For details on creating a custom listing, see Create a custom listing.
2. Click the More Actions icon from the Custom Listings title bar, then do one of the following:

   • Click the Save as Query icon to save the listing for use in another session. For new queries, the Save operation includes installation.

   • Click the Install Custom Listing icon to install the listing. This is required only for copied queries.

Copy a custom listing

1. After you select a study, click Data Management in the navigation bar.

   Note:

   For details on selecting a study, see Select a study.
2. Select Custom Listing Manager from the drop-down menu to open the Custom Listing Manager tab.
3. From the Custom Listings header in the left panel, click the More Actions icon, then click Copy Custom Listings.
4. Select a project (or other study grouping).
5. Select a model.
6. Select one or more custom listings within the model.
7. Click OK. The system searches the current model for the tables and columns that the selected custom listings read from.

   • If the tables or columns do not exist, the Copy operation fails with an error message.

   • If they exist but are marked Not Used in the transformation that writes to the model, the system copies the listings as disabled.

Use the Expression Builder

There are two ways to add an expression, with different advantages:

• Use the Expression Builder user interface. This more cumbersome process makes the transformations, validation checks, and custom listings that use it easier to copy and map in the new study.

• Enter code as free text directly in the Expression Text field. This is a simpler process for a programmer but results in a less easily reusable transformation, validation check, or custom listing.

  Important:

  • If you reference a static package or function in free text, you must select it in the Selected Packages tab.

  • In free text, use just the column name, not the table.column format, unless you need to use an alias, as in a self-join. In that case the alias.column format is required.

To use the Expression Builder:

1. In the Expression Criteria pane, select the following as needed to build the expression from left to right.

   • Add Group to add the parentheses () that surround a phrase in an expression or group smaller units of logic.

   • Add Item to add a unit of logic smaller than a group.

2. To add a phrase within a group, click the parentheses ().

   To add a phrase outside a group, click Expression.

3. To add an item, in the Expression Item pane select Column, Function (for functions written by your company), or Standard Function (for Oracle SQL functions).

   To create an expression using column values:

   1. For Item Type, select Column.

   2. Click the Select Column icon.

      In the Select Column window, you can filter above any of the attribute columns to find the table column you want. Select a column and click OK.

   3. If needed, select an operator from the list.

   4. If needed, enter a data value. The system encloses the value you enter in single quotes.

   5. If needed, select a conjunction from the list.

      Tip:

      If you select a conjunction within a group, it appears within the group, at the end. If you need a conjunction outside the group, click Expression above, then select the conjunction.

   6. Click Add. The system generates the SQL expression and displays it in the Expression Text pane.

      Note:

      You can edit the generated code in the Expression Text pane, but if you do, you cannot continue to build the expression in the user interface.

      Click Validate to check the generated code.

   To use a function in your library:

   1. For Item Type, select Function. The Select Function window appears, displaying a list of Oracle functions.

   2. Select a function and click OK.

   To use a standard SQL function:

   1. For Item Type, select Standard Function.

   2. Click the Select Standard Function icon. A search window appears. To filter, enter all or part of the name in the field above. You can use the wildcard %.

   3. Select a function and click OK.

4. Define additional groups and items to complete the expression as necessary.

5. Click Save.

6. Click Validate. The system validates the code and displays any errors or warnings.

   To make a correction in the Expression Builder:

   1. Select the faulty item in the Expression Criteria pane. An Update button appears in the Expression Item pane.

   2. Make your changes in the Expression Item pane and click Update.

      For more information, see the following sections.

• Pass data as input parameter values
  
• Pass constant values
  

Pass data as input parameter values

Use curly brackets ("{" and "}") as delimiters and the fully qualified format (model.table.column) to indicate input parameter values to SQL functions or custom functions in the expression. The default input is the column value if no metadata is specified after the column name.

For example, to calculate a subject's age from his date of birth:

round((sysdate - {Review.LAB_SRC.dob})/365)

where Review is the data model name, LAB_SRC is the table name, and dob is the column name. No metadata follows the column name, so by default the system passes the Date of Birth (dob) data value to the expression.

Pass constant values

You can hard-code a value for a target column using an expression that contains only a constant value or by calling a SQL function based on constants, for example:

round(3.14 * power(10, 2))

FAQs

This section includes the following topics:

• Listings FAQs
  
• Flag FAQs
  
• Data lineage FAQs
  

Listings FAQs

This sections includes details on these listing questions:

• What is a clinical data model?
  
• One of the rows says "Yes" under the Discrepancy_Exists Column, but no cells are highlighted yellow. Where is the discrepancy?
  
• What is a disabled listing?
  
• Where can I copy a custom listing from?
  
• What happens if I modify a Table Alias?
  
• How can I view blinded data?
  
• How can I resend data that needs coding to TMS?
  

What is a clinical data model?

A clinical data model is a logical set of tables of study data. They were either loaded together into DMW from a single source or they contain data transformed by your study configurator for a purpose such as data review or analysis.

One of the rows says "Yes" under the Discrepancy_Exists Column, but no cells are highlighted yellow. Where is the discrepancy?

An active discrepancy filter has probably identified a discrepancy in a column that is not displayed.

What is a disabled listing?

Listings are disabled if a table they read from is not used in the study.

Where can I copy a custom listing from?

You can copy custom listings from another study or from a different clinical data model in the same study. The system checks if the required source tables are available in the current model.

What happens if I modify a Table Alias?

If you are creating the listing and modify the alias after defining an expression or criterion that refers to the original alias, you must update the expression or criterion manually before saving.

If you are modifying a saved listing and modify an alias, the system will update the expression or criterion when you save, as long as the expression or criterion was originally created using the Expression Builder.

How can I view blinded data?

When you choose a listing that contains blinded data and your account includes the privileges to view it, Oracle DMW prompts you to confirm that you want to access the blinded data.

After clicking Yes, you can use the Show Blinded Data field in the Filters tab of the Listings page or the Filter panel of the Discrepancies page to toggle between viewing or not viewing blinded data or masking values.

How can I resend data that needs coding to TMS?

If you make structural changes like updating a dictionary or adding columns to hold derived data from TMS, you can send all data that has been designated as needing coding by running the Force Rederivation job.

1. Open the Home page.
2. Select a study.
3. Click the Modify Study icon in the Studies panel.
4. Click the TMS tab.
5. Click Force Rederivation to run Rederivation once, immediately. A confirmation message opens to notify you of a long processing time. But, you can still work while the rederivation runs.
6. Click OK.

Flag FAQs

• Why can't I assign a flag?
  
• Can the flags I assign be seen in InForm?
  
• I wish a different flag were available.
  
• Why can't I change some flags?
  

Why can't I assign a flag?

The Assign Flags function is available only if flags have been defined for the current data model type and if you have the privileges required to assign flags.

Can the flags I assign be seen in InForm?

You can only see Oracle DMW flags in Oracle DMW.

I wish a different flag were available.

Your administrator creates the flags you can assign in DMW.

Why can't I change some flags?

Flags that start with Inf_ are CRF form and section states imported from InForm as flags. After the Inf_ the name is the same as in InForm. You cannot change these flag assignments in DMW. Each of these flags has two states: Yes an No (Y and N).

Data lineage FAQs

• What is data lineage?
  
• When I create a discrepancy against a data item, how does that affect the data lineage?
  
• Why does the wrong source data item have the discrepancy?
  

What is data lineage?

A single data item, such as a subject's weight, appears in DMW first as loaded from InForm or another system and then in subsequent downstream clinical data models. DMW maintains tracks each data item as it appears in each model.

The column name may change from one model to the next, for example from WT to WEIGHT, and the value may be converted to different units and used to derive other values, such as Body Mass Index (BMI).

When I create a discrepancy against a data item, how does that affect the data lineage?

The system immediately displays the discrepancy against the corresponding data items upstream and downstream.

Why does the wrong source data item have the discrepancy?

When a data item like a derived BMI has more than one source data item, the validation check must designate a single column as the one against which to create the discrepancy, even if it is impossible to know in advance which one is faulty. A BMI that is out of range might be due to a bad value for height, weight, or unit, but one of them must be preselected. However, all relevant values can be displayed.

See also Why is a query on a different item in InForm than in DMW?.