| Oracle® Health Sciences Data Management Workbench User's Guide Release 2.4 E52292-02 |
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Home > User's Guide > Reviewing Data
| Oracle® Health Sciences Data Management Workbench User's Guide Release 2.4 E52292-02 |
|
|
PDF · Mobi · ePub |
Home > User's Guide > Reviewing Data
In the Listings pages you can view clinical data, create discrepancies identifying possibly flawed data, and view existing discrepancies imported from Oracle Health Sciences InForm (queries) or raised by validation (edit) checks or by other people. You can create your own custom listings and view custom listings that other people have made public.
To see data listings:
On the Home page, select the study and lifecycle mode and click Listings.
Under Listings, select the name of the clinical data model you want to view. The system lists all models in the current study to which you have security access.
In the right pane, select the type of listing you want to view:
Default Listings to see all study data to which you have access.
Custom Listings to create your own listings or use those that other people have marked Public.
VC Listings to see discrepancies identified by validation (edit) checks.
Note:
The links for Custom and VC Listings are located at the bottom of the pane.Model Name: Select the clinical data model you want to view. The system displays the tables in that model.
A clinical data model is a set of tables grouped by your company for a purpose. Each study has several data models that store data in exactly the form loaded from the sourceâInForm or a lab. People in your company then combine and transform that raw data as required for review and analysis in sequence, creating a data model for each purpose and perhaps intermediate data models as well. You may have access to only one model.
Select the table whose data you want to view. The system displays the data, with table column names (items) across the top and a row for each record.
Different listings pages display different data.
Default listings show all data in all tables in a clinical data model with the exception of blinded, masked data. The system always displays the most current data, updating the last modification timestamp each time data is updated.
InForm queries are converted to discrepancies and displayed and tracked along with discrepancies created manually or by validation checks.
You can select multiple records using Ctrl+click or Shift+click at the beginning of each row.
You can view custom listings saved as public and you can create ad hoc listings.
To view a saved listing, select it in the Custom Listing pane. The current data appears on the right.
To create your own listing, click the Add icon in the Custom Listing pane; see "Using the Query Builder to Create Custom Listings".
To create a new listing from an existing one click the Modify Custom Listing icon, modify it, and save it with a different name.
To copy saved custom listings, click the Copy Custom Listings icon; see "Copying Custom Listings". You can modify the copy.
Select Show disabled custom listings to view only listings that are not available because a table or column they reference is marked Not Used in this study.
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.
Tip:
If your custom listing displays a row where the Discrepancy_Exists column says Yes but no cells are highlighted to indicate where the discrepancy is, it is probably because an active discrepancy filter has identified a record with a discrepancy in a column that is not displayed in the listing.Discrepancy filters apply to discrepancies in all columns of the full records retrieved by the custom listing.
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.
Navigate to the Listings page, then Custom Listings in the lower left pane.
In the Custom Listings pane, click the Copy Custom Listings icon. The Copy Custom Listings window opens.
The system displays all study clinical data models to which you have access. You can type part or all of the name of the therapeutic area (or other category), study, or model to filter the list.
Click Clear Filters to remove all typed text and revert to the full list.
Select a model. The system displays all the custom listings associated with the model. To filter, type all or part of a custom listing name and press Enter.
Select one or more custom listings. Use Ctrl+click or Shift+click to select multiple checks.
Click OK. The system searches the current model for the tables and columns that the custom listings read from, first by Oracle name and then by alias.
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 and displays the reason they are disabled on the Custom Listings page.
If the tables and columns exist and are used, the system copies the custom listings and links them to the appropriate tables and columns.
To create a new custom listing:
Click the Add icon to create a new custom listing. The Add Custom Listing pane appears.
Enter a name and description for the custom listing. The name is displayed on the Listings page but the description is not. The Listings page can display about 25 characters of the name without requiring scrolling to see the whole name. Consider using a naming convention.
Select Mark as Public to enable users with the required security access to the data model and to the Listings pages to view the custom listing produced by this query. The query is not public until you save it.
Select Authorize access to this listing for users without Blind Break rights if you know that only nonblinded data will be displayed in the listing. This option is available only if at least one source table contains blinded data and if you have the required blinding-related privileges.
If any source table is blinded at any level and this attribute is not selected, the system blinds the entire target table, so that by default no data is displayed on the Custom Listings page for this listing. Only a user with the required Blind Break privileges can view the data.
In the Source pane, select the clinical data model whose data you want to view.
Specify the columns to display; see "Selecting Columns to Display in Custom Listings". The system creates a SELECT clause based on your specifications.
If you need to use a function from a library in the SELECT or WHERE clause, and you plan to write the expression using the function in free text, open the Select Packages tab and check the packages you will use. This enables the system to generate the query code and supports the Test function.
If you use the Expression Builder (reached by clicking the Modify Expression icon), you do not need to use the Select Packages tab.
If you need to use a self join in the SELECT clause, open the Define Table Alias tab and click the Add icon to add another row for the same table. Specify a different aliases for the table in each row. Use the aliases to create a self join in the Criteria pane.
Note:
The table alias must be three characters or less. If it is longer it causes problems.Specify query criteria; see "Specifying Criteria". The system creates a WHERE clause based on your specifications.
Click OK.
In the Select Columns tab, identify the columns to display for each record retrieved by the query. You can give columns a different header for display and you can combine or write expressions on one or more columns. The system creates a SELECT clause for the query based on your specifications.
In the Source pane, expand the node for the table or tables whose data you want to display in the VC Listings page for each record retrieved.
Note:
Tables and columns marked Not Used in the transformation are not displayed here, nor are uninstalled tables.Select the columns you want to display. You can use Ctrl+click and Shift+click to select multiple columns at a time. You can also select a table to add all its columns and then remove the ones you do not want to display.
Click the Add icon. The system displays the columns you selected under Selected Columns, each in its own row.
To write an expression that operates on multiple columns you must add all columns in the expression to the same row:
Move one column into Selected Columns using the Add icon and highlight it there.
Select the additional columns in the Source pane and click the Arrow icon in the Source pane. The system adds them to the same row.
Table Alias: If you have defined table aliases for a table in a self join in the Define Table Alias tab, select a column and click the Select Table Alias icon to specify which table alias the selected column belongs to.
Alias: To display a heading for the column different from the column name, enter it in the Alias field.
Sort Order: Enter a number to determine the column's display order relative to other columns in this custom listing.
Sort Type: Select Ascending (ASC) or Descending (DESC) for the listing display.
Expression: Add the expression, if any, to operate on the column in the SELECT clause. Enter free text or click the Modify Expression icon to use the Expression Builder; see "Using the Expression Builder in Validation Checks and Custom Listings". You can edit code generated by the Expression Builder in this field afterward.
If you need to use a function from a library in the SELECT or WHERE clause, open the Select Packages tab and check the package you need. The system displays all packages in the DMW_UTILS domain; see "Developing a Library of SQL Functions". The system then selects that package by default when you select Function in the Expression Builder. You can select a different package in the Expression Builder if needed.
To create a self-join:
Add the table and column(s) to the Selected Columns tab.
Open the Define Table Alias tab and click the Add icon to add the table as many times as required.
Specify a different alias for the table in each row.
Note:
The table alias must be three characters or less. If it is longer it causes problems.If your alias includes a space, the system replaces the space with an underscore (_) when you save.
In the Selected Columns tab, select a column and click the Select Table Alias icon to specify which table alias the selected column belongs to.
Specify the join criteria in the Criteria pane. See "Using the Expression Builder in Validation Checks and Custom Listings".
In the Criteria pane, build the WHERE clause.
Click the Add or Modify Criteria icon to open the Expression Builder. See"Using the Expression Builder in Validation Checks and Custom Listings".
You can edit code generated by the Expression Builder or enter code directly in the Criteria pane.
Note:
Oracle recommends using the Expression Builder to add columns so that Oracle DMW "knows" what you are using in the expression and can use table and column aliases defined in the clinical data model to help determine if source tables and columns exist when you copy custom listings.You can test the query or view the generated code at any time using these buttons:
Test: The system generates PL/SQL code, validates it, and either displays an error message if the code is not valid or displays the records retrieved in the Test Results pane.
View Source: The system generates and displays the PL/SQL code resulting from the query you define in the query builder.
Select a Custom Listing in the list on the left and:
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.
Click the Update Status icon to promote the listing to QC (Quality Control) or Production for validation purposes.
Validation checks (edit checks) identify faulty or questionable dataâfor example, missing or out-of-range values, or values that do not make sense when compared to related values. Validation checks generate a discrepancy against each data point they identify, give the discrepancy a status of either Open or Candidate, and may apply a tag identifying the discrepancy as requiring medical review first. Validation checks may be set up to close discrepancies they created if the underlying data point is fixed. If not, manual resolution is required.
Each validation check tests for a single problem and writes all the open or candidate discrepancies it finds to a single table, which is displayed in VC Listings.
Select a Validation Check under VC Listings to see its results in the main pane.
Validation checks run in batches on a regular basis as configured in the Activities page; see "Viewing and Running Validation Check Batches".
Tip:
If your validation check listing displays a row where the Discrepancy_Exists column says Yes but no cells are highlighted to indicate where the discrepancy is, it is probably because an active discrepancy filter has identified a record with a discrepancy in a column that is not displayed in the listing.Discrepancy filters apply to discrepancies in all columns, including columns of auxiliary information, of the full records retrieved by the validation checkânot just the discrepancies identified by the validation check.
For example, to see only open validation check discrepancies, not validation check discrepancies that have been manually closed for a reason other than data change, you can apply a Discrepancy State filter in the VC Listings page. (Discrepancies that are closed because the underlying data no longer meets the criteria of the validation check are no longer displayed in the VC listing.) However, you will see all records with any open discrepancies, even if the discrepancy raised by the validation check on the record has been manually closed, and even if the column with the open discrepancy is not displayed in the listing.
You can do the following on any Listings page:
Use filters to limit the data you see in the Listings and Discrepancies pages. You can apply more than one filter at a time and save filter groups. When a filter is applied, the message "Filters On" appears on screen. To see which filters are currently applied, click the Current Filters icon.
To remove all current filters, click the Filter Off icon.
To open the main Filters window, click the Filter icon. Then:
Optionally, select Show Filters Shared by Others to see and use filters others have created and marked as Shared. Shared and private filters you created are always available to you, even if this box is unchecked. Filters marked as Public are always available.
Select a filter to apply. The drop-down list for each type of filter displays all the filters to which you have access.
Create a new filter by clicking the Add icon for the filter type. Filters you create are private filters unless you make them shared or public. Creating and modifying public filters requires special privileges.
View or edit a filter: Select the filter from the drop-down list and click the Modify Filter icon to see the filter criteria or modify them.
Note:
You cannot modify filters created by someone else and marked as Shared. However, you can copy Shared or Public filters, modify the copy, and save it with a different name. You can modify public filters anyone created if you have special privileges.Delete a saved filter by selecting a filter and clicking the Delete Filter icon. You can delete private and shared filters you created, and you can delete public filters anyone created if you have special privileges. You cannot delete a filter if it is part of a filter group.
Make your private filters shared or public by selecting them and changing the value of the other drop-down list to Shared or Public. Special privileges are required to make filters public. Shared and public filters are available to everyone with the privileges required to view data in the study.
Select Keep Active to keep the filters in effect until you change studies or lifecycle modes, or log out, even if you navigate between the Listings and Discrepancies pages. If a particular filter cannot be applied in a new window, a message appears.
If Keep Active is not selected, when you navigate to a different page, the filter is removed the current session, even if it is a named, saved, filter.
Note:
To save a filter for use after you log out, give it a name and click OK.Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Select, create, edit, or delete a Filter Group; see "Creating and Using Filter Groups".
Click OK. Clicking Reset changes all filters to Not Set.
The screenshot below shows the main Filters window with four filters selected. Two are private filters created by the current user, one is a shared filter created by another user, and one is a public filter created by another user with special privileges:
The shared Subjects filter named BOSTON HOSPITAL filters for subjects in the Boston Hospital site.
The private Visits filter named CYCLE A filters for records collected in visits that are part of Cycle A. This private filter has a name and is saved for future use.
The public Discrepancy Categories filter called INFORM filters for discrepancies on data that originated in InForm.
The private Discrepancy State Dates filter is unnamed and unsaved. It filters for records whose discrepancy state changed between specific dates that you can see if you click the Modify Filter icon.
All these filters are applied to the data at the same time, so that the system displays only data that satisfies the criteria for all filters. In the case of the discrepancy filters, the system displays only records with discrepancies that meet the criteria for state change date range and have the InForm category applied.
All filters in the example are set to Keep Active so that as long as the current user stays in the current study and lifecycle, the filters apply, if possible. If the user views data in a table that does not have a column required for the filterâsuch as a Visit column or Site column in this exampleâthe system ignores that filter.
If you have applied a discrepancy filter in a Listings page, the system displays records that have discrepancies that meet the filter criteria with an additional star icon.
See "Defining Tables to Support Filtering in the Listings Pages" for information on filtering requirements.
Filter groups apply multiple filters at the same time.
To use a filter group, click the Filter icon, select the group from the Filter Group list, and click OK.
Click the Filter icon in the Listings or Discrepancies page, then:
To create a new filter group, click the Filter Group Add icon.
To create a new group based on an existing group or modify an existing group, select the group from the list and click the Filter Group Edit icon.
To query for a filter group, click Search at the bottom of the list. Enter part or all of the name with the wild card % and/or enter the class (Public, Private, or Shared). Click Search.
Select filters for the group.
Select Keep Active for the filters that you want to remain active if you leave the page.
Enter a Name and Description for a new group. Leave as is to modify a group.
Save As Copy (Available only if you clicked the Edit icon.)
Select to save the group with a different name, leaving the original group unchanged.
Leave unselected to modify the existing group.
Click OK. You return to the main Filters window.
(Optional) Make the group public or shared.
Public filter groups can contain only public filters. Making a group public requires special privileges.
Shared filter groups that you create can contain shared filters owned by you and public filters.
Private filter groups can contain any filters, including those that are shared and owned by others.
Click OK to apply the filters and go back to the Listings or Discrepancies page.
To see which filters are currently applied, click the Current Filters icon. The Current Filters window opens, and for each currently applied filter, displays:
Filter name
Filter type
Filter class (private, shared, or public)
Filter description
To turn all filters off, click the Filters Off icon. To selectively turn off, turn on, or modify filters, click the Filters icon.
You can filter records based on characteristics of subjects, including their country, site, investigator, or ID. Subject filters require a Subject Visit Table table with columns mapped to SDTM identifiers. To create a Subject filter:
Filter Driver Data Model: Select the clinical data model that contains the Subject Visit table that you want the filtering logic to use. The system uses the columns in this Subject Visit table to determine which Filter Types are available.
Tip:
Whenever possible, use the same model as the Filter Driver Data Model in different filters for the same study. If two filters that use different driver models are applied at the same time and you navigate to the Discrepancies page, the system ignores both filters and gives a warning notifying you that the filters are being ignored.Filter Type: Select one:
Countries
Sites
Site IDs
Investigator Names
Investigator IDs
Subject IDs
Unique Subject IDs (ID unique across studies)
The system displays the type you select and all the types above it in the list as columns in the filter window, with one row for each distinct value for the selected filter type.
Note:
If the Subject Visit table in the Filter Driver data model does not have a column mapped to the SDTM identifier for Country, Site, Site ID, Investigator Name, Investigator ID, Subject ID, or Unique Subject ID, the column is not displayed.You can enter all or part of a value above any column to filter the rows displayed.
Select one or more rows to be the filter value.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability:
Study Level makes the filter available in all data models in the current study and lifecycle.
Data Model Level makes the filter available only in the current data model and lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
Visit filters can be defined only in the context of a data model with a table that meets all requirements for a Subject Visit Table. To create a filter for a single visit:
Filter Driver Data Model: (Required) Select the clinical data model that contains the Subject Visit table that you want the filtering logic to use. This does not restrict you to using the filter only in that model.
Filter Type: Select one of the following:
Visit Cycle
Visit Number
Visit Name
The system displays all three columns with a row for each visit. You can enter all or part of a value above any of the columns to filter the choices displayed. For example, type the name of a visit cycle to see only visits in that cycle.
Select a row to be the filter value.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability:
Study Level makes the filter available in all data models in the current study and lifecycle.
Data Model Level makes the filter available only in the current data model and lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
On the Listings page, use this filter to find records with particular Subject/Visit-type flag states, or values, assigned.
On the Discrepancies page, use this filter to find discrepancies whose underlying data have particular Subject/Visit-type flag states, or values, assigned.
Filter Driver: Select the clinical data model that contains the Subject Visit table that you want the filtering logic to use. This does not restrict you to using the filter only in that model.
As you browse data in different models and tables, if the current table does not have a Visit column, the system ignores this filter.
Select whether you want to retrieve data that meet Any or All conditions.
The system lists all flags and flag states, or values. You can enter part or all of a flag or flag state name above the column to filter. For each flag state:
Select Include to find records with the flag state applied.
Select Exclude to find records that do not have the flag state applied.
If you select neither Include nor Exclude, the flag state is not included in the filter criteria at all.
Filter Availability is Study. Saved filters of this type are available for use only in the current study and lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
If you do not name the filter, the system calls it Temporary Filter and it is available only during your current session.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
To create a filter based on the visit day number in the study design:
In the Condition drop-down, select an operator: <, <=, <>, =, >, >=, Between, Is Not Null (has any value), and Is Null (has no value).
The system displays 0, 1, or 2 fields depending on which operator you select. Enter visit day numbers as required.
Filter Driver Data Model: Select the clinical data model that contains the Subject Visit table that you want the filtering logic to use. This does not restrict you to using the filter only in that model.
As you browse data in different models and tables, if the current table does not have a Visit column, the system ignores this filter.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is Study Level; filters of this type are available in all data models in the current study and lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
To create a filter based on the actual visit date:
In the Condition drop-down, select an operator : <, <=, <>, =, >, >=, Between, Is Not Null (has any value), and Is Null (has no value).
The system displays 0, 1, or 2 date fields depending on which operator you select. Enter values as required.
Filter Driver Data Model: Select the clinical data model that contains the Subject Visit table that you want the filtering logic to use. This does not restrict you to using the filter only in that model.
As you browse data in different models and tables, if the current table does not have a Visit column, the system ignores this filter.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is Study Level; filters of this type are available in all data models in the current study and lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
On the Listings page, use this filter to find records with particular Record-type flag states, or values, assigned.
On the Discrepancies page, use this filter to find discrepancies whose underlying data have particular Record-type flag states, or values, assigned.
Select whether you want to retrieve data that meet Any or All conditions.
The system lists all flags and flag states, or values. You can enter part or all of a flag or flag state name above the column to filter. For each flag state:
Select Include to find records with the flag state applied.
Select Exclude to find records that do not have the flag state applied.
If you select neither Include nor Exclude, the flag state is not included in the filter criteria at all.
Filter Availability is All Studies. Saved filters of this type are available for use in all studies in the current lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
If you do not name the filter, the system calls it Temporary Filter and it is available only during your current session.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK
The Data Change Date filter displays records whose most recent update occurred during the time period specified.
In the Condition drop-down, select an operator to be used to select the dates. The options are: <, <=, <>, =, >, >=, Between, Is Not Null (has any value), and Is Null (has no value).
Note:
Selecting Is Not Null retrieves all records; there is always a value for last-changed-date. If the record has not been updated, it is the same as the creation date.The system displays 0, 1, or 2 date fields depending on which operator you select. Enter values as required.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is Study Level; filters of this type are available in all data models in the current study and lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
The Discrepancy Category filter displays only records that have one or more discrepancies of the categories specified.
In the Discrepancy Categories drop-down, select one or more categories to be used to filter, or click All and then deselect categories.
Your company defines the categories; see "Viewing and Creating Categories".
Check Include *(No Category)* include or exclude discrepancies with no assigned category.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is All Studies. Saved filters of this type are available for use in all studies in the current lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
The Discrepancy Change Date filter displays records that have one or more discrepancies whose most recent update occurred during the time period specified. To create a Discrepancy Change Date filter:
In the Condition drop-down, select an operator: <, <=, <>, =, >, >=, Between, Is Not Null (has any value), and Is Null (has no value).
Note:
Selecting Is Not Null retrieves all records; there is always a value for last-changed-date. If the record has not been updated, it is the same as the creation date.The system displays 0, 1, or 2 date fields depending on which operator you select. Enter values as required.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is All Studies. Saved filters of this type are available for use in all studies in the current lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
The Discrepancy State Date filter displays only records that have one or more discrepancies whose most recent state change occurred during the time period specified.
In the Condition drop-down, select an operator : <, <=, <>, =, >, >=, Between, Is Not Null (has any value), and Is Null (has no value).
Note:
Selecting Is Not Null retrieves all records; there is always a value for last-changed-date. If the record has not been updated, it is the same as the creation date.The system displays 0, 1, or 2 date fields depending on which operator you select. Enter values as required.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is All Studies. Saved filters of this type are available for use in all studies in the current lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK
Use this filter to find discrepancies in a particular state, with or without a substate (tag).
In the Listings page, the filter finds records with discrepancies that meet the criteria.
In the Discrepancies page, the filter finds discrepancies that meet the criteria.
Discrepancy State and Tag. The list includes all discrepancy states followed by all possible substates, or tags, for each state. Each stateâfor example, Open or Candidateâis also displayed without any tags. Selecting that option finds discrepancies with that state and no tags. To filter for all discrepancies in a state, regardless of tag, select all state/tag combinations for the state.
Reopened. Select Yes to view reopened discrepancies only; No to view discrepancies that are not currently reopened; or All to see discrepancies without regard to whether they are reopened or not.
Data Changed. Select Yes to view discrepancies whose underlying data has been updated since the discrepancy was created; No to view discrepancies whose data has not changed since the discrepancy were created; or All to see discrepancies without regard to whether their data has changed.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is All Studies. Saved filters of this type are available for use in all studies in the current lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
If you do not name the filter, the system calls it Temporary Filter and it is available only during your current session.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
Use this filter to retrieve discrepancies by the person who created or most recently modified a discrepancy.
Filter Type. Select the way you want to search:
Created By
Modified By
The system displays all Oracle DMW users, with their user name, full name as entered in the system, and any external systems such as InForm or TMS that they also use. You can enter part or all of any of these values above the column to filter.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is All Studies. Saved filters of this type are available for use in all studies in the current lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
If you do not name the filter, the system calls it Temporary Filter and it is available only during your current session.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
Use this filter to retrieve discrepancies by the way they were created.
Discrepancy Origins. Select one or more to search for:
All returns all discrepancies, regardless of origin.
InForm returns discrepancies created as queries in InForm.
Manual returns discrepancies created manually in Oracle DMW.
TMS returns discrepancies created as omissions in Oracle Thesaurus Management System (TMS). This option applies only if you have TMS integrated with Oracle DMW.
Validation Check returns discrepancies created by validation checks in Oracle DMW.
Check Exclude Based On Criteria to filter out records that satisfy the criteria. This is the equivalent of adding "Not" to the query logic. Leave unchecked to display only the records that satisfy the criteria.
Filter Availability is All Studies. Saved filters of this type are available for use in all studies in the current lifecycle.
Filter Name: Enter a descriptive name for the filter to save it to use in another session; that is, after you log out or work in a different study.
Filter names must be unique across all private, shared, and public filters that you can see in a particular study and lifecycle.
If you do not name the filter, the system calls it Temporary Filter and it is available only during your current session.
Description: Enter additional text to help you and other users know if this filter meets their needs. The description is displayed in the Edit Filter window and in the Filter Criteria window that lists all filters currently applied on a page.
Save As Copy. This option is available only when you are editing an existing, named filter. If this option is selected, you can make changes and save the filter with a different name.
Click OK.
On the Listings pages you can use the Find feature to search on values in the columns of the current table.
Click the Find icon. The Find window opens, displaying an enterable field for each searchable column in the table currently displayed in the Listings page.
Enter or select the values you want to search for, and click one:
Any: finds records that satisfy at least one Find criterion.
All: finds only records that satisfy all Find criteria.
Alternatively, click Advanced. Any values you have already entered remain in effect. Advanced Find allows you to use operators on each column:
Number operators: Equals, Does not equal, Less than, Less than or equal to, Greater than, Greater than or equal to, Between, Not between, Is blank, Is not blank.
Character (alphabetic) operators: Starts with, Ends with, Equals, Does not equal, Less than, Less than or equal to, Greater than, Greater than or equal to, Between, Not between, Contains, Does not contain, Is blank, Is not blank.
Date operators: Equals, Does not equal, Before, After, On or before, On or after, Between, Not between, Is blank, Is not blank.
Then enter values to search on.
Click:
Search to find the criteria you have specified.
Reset to remove all criteria.
Add Fields (available in the Advanced window only): To add criteria for a column already used, you can add another field for the column and specify another operator and valueâfor example, Site Country contains US or (Any) Site Country contains CANADA.
If you find faulty or questionable data, you can create a discrepancy against it. You can select multiple data points with the same issue and create a discrepancy against all of them at the same time.
After a discrepancy is created, it is visible everywhere its underlying data point is visible, including in other data models and listings.
To create a discrepancy:
In the Listings page, select the record or records against which you want to create a discrepancy. Select records with the same type of problem so that the discrepancy text can be the same for all.
Click the Create Discrepancy icon.
Enter values:
Discrepancy: Enter text that describes the problem with the data or the action requiredâfor example, "Diastolic blood pressure is not within the specified range. Please confirm or correct."
The system generates an ID beginning with "Oracle DMW" followed by numbers and adds it to the beginning of this text when you save. This ID is required for internal processing.
Category: Select from the list, according to your company's policy. You can use the category as a filter in the Discrepancies page.
Whether or not a category is required depends on a profile setting. See "Make Discrepancy Categories Mandatory."
State: Select Open or Candidate, according to your company's policy. Candidate discrepancies require manual review before being moved to Open status and then being resolved.
Data Model: The system displays the current data model.
Discrepancy Count: They system displays the number of discrepancies currently open on the same data point.
Append User Name: Select the check box to append your username to the discrepancy text to make it visible in InForm and at labs. Your username is stored in the database regardless of this setting and is displayed in the History pane of the Discrepancies page.
This check box may be inactive, depending on a profile setting. See "Append Username to Discrepancy Text."
Actions: Select an action from the listâfor example, Send to InForm. The system applies the action to the discrepancy when you click OK.
Whether or not an action is required depends on a profile setting. See "Make Discrepancy Actions Mandatory."
Click OK.
To act on a discrepancy, select it and click the Manage Discrepancies icon. The Manage Discrepancies window opens, and you can work on that one discrepancy just as in the Discrepancies page. When you are finished, close the window to work in the Listings page again with the same data displayed.
You can also select a discrepancy and click the Go to Discrepancies icon to go to the Discrepancies page, but when you finish working there and return to the Listings page, you have to reset the context.
Records with one or more discrepancies have a yellow rectangle on the left and the word Yes in the DISCREPANCY_EXISTS column. In the cell for each data point in the row with a discrepancy, the system displays the icon for the discrepancy's state. If a data point has multiple discrepancies, the system displays the icon for the state that requires the most work to resolve. The order is:
Open
Candidate
Answered
Cancelled
Closed
In addition, if you have applied a discrepancy filter, the system displays data points that have the discrepancies that meet the filter criteria with an additional Star icon.
To see all discrepancies associated with a particular data point, select the data point and click the Show Discrepancies icon. For each discrepancy the system displays:
Icon showing the current state of the discrepancy; see "Discrepancy Display" for an explanation of each icon.
Discrepancy ID.
Discrepancy: Text that describes the data problem or the action required.
Tag: The tag currently applied to the discrepancy, if any.
Latest Comment: People can communicate with comments about a discrepancy. The latest one is displayed.
To see the complete discrepancy history and to take action on discrepancies, go to the Discrepancies page or click the Manage Discrepancies icon.
To show all flags currently applied to a record, select it and click the Show Flags icon. The system displays each flag name, its applied value (state) and its priority, as well as the timestamp of the data when the flag was applied. You can click a column header to sort the flags by name, value, or priority.
Records that have at least one flag assigned have an icon displayed to the left of the row that represents the highest priority flag state currently applied to the record:
High priority flag state.
Medium priority flag state.
Low priority flag state.
Flags provide information about the state of a record. Record flags track the data review process. Subject Visit flags track data completeness. You can filter on any flag. InForm CRF form and section states are imported as flags, and your administrator can create flags for use within Oracle DMW (see "Creating and Using Flags"). A flag has one or more states, or values, each with a priority relative to other values of the same flag and other flags. A record can have multiple flags applied at the same time, each with a single value.
InForm CRF form and section states are imported as flags. You cannot change these flag assignments in Oracle DMW. Each InForm flag has two states: Yes and No (Y and N). They have the same names that they do in InForm plus the prefix "Inf_":
You can apply any number of flags to a record, but only one flag value at a time. Your company creates flags as needed; see "Creating and Using Flags".
Assign Flag To assign a flag to a record:
Select a record and click the Assign Flags icon.
Select the flag to assign.
Select the flag state value to assign.
The system compares the record's displayed timestamp with the last data update and if there is more recent dataâa data load has completed while you were viewing the pageâa message appears telling you to refresh the page and the flag is not assigned. Click the Refresh icon.
If you the most recent data is already displayed, the system applies the flag state.
Note:
The Assign Flags icon is active only if flags have been defined for the current data model type and if you have the privileges required to assign flags to data.Select a record and click the Assign Flags icon.
Select the flag to remove.
Select Clear Flag at the bottom of the list of flag states.
A single data pointâfor example, a subject's weightâappears first as loaded from InForm or a lab and then in subsequent downstream clinical data model. The column name may change from one model to the nextâfor example, from WT to WEIGHTâand the value may be converted to different units and used to derive other values, such as Body Mass Index (BMI). You can trace each data point's trail. For example, from the WEIGHT value in kilos in the Review model you can see the same value as WT in pounds in the InForm input model upstream and the BMI in the Analysis model downstream.
Note:
You can create a discrepancy against a data point in any clinical data model and the system will immediately display the discrepancy against the corresponding data points upstream and downstream. See "How the System Tracks Data Lineage" for more information.To view data lineage of a data point:
Select the data point.
Select one:
View Source Data to see upstream data that contributed to the selected data point. The system traces back as far as the input data model that receives data in the same structure as in the source system.
View Target Data to see downstream data that the selected data point contributes to.
View Preferred Path to see upstream data designated as the preferred path for sending related discrepancies back to the source system. If there are multiple source data points, one must be designated as preferred when the discrepancy is created. The system displays the discrepancy on the data points in the preferred path.
The Trace Data Lineage window appears:
The window displays the selected data point in the top row. Expand its node to see the immediate source (upstream) or target (downstream) data point. Expand that node to see its immediate source or target data point, and so on. If there are multiple immediate source or target data points, they are all displayed at the same level of indentation.
For each data point in the path, the window displays:
Name: The item or column name preceded by its table name and data model name: data_model_name.table_name.column_name.
Is Masked: If a dollar sign ($) is displayed, the displayed data point may be a masked value instead of real data. Its table or column contains masked data, but this particular data point may not be masked.
Is Staging: If a # is displayed, the data point displayed is in a staging table used in a transformation, not in a clinical data model table.
Value: The data value.
Link to InForm: If the data originated in InForm, click the View Data in InForm icon to open InForm and see the data in context there.
Incomplete Lineage: If an asterisk (*) is displayed after the column name in the Name column, the system cannot display a data point and the rest of its path. This may be because:
The data point has been deleted or unmapped.
You do not have the privileges required to view the data point, either because you do not have access to view its table at all or because the table is fully or partially blinded and you do not have the required blinding-related privileges.
Data Type: The item's data type.
Preferred Path: Yes if the data point is on the preferred path or the only path; No if there are multiple paths and the data point is not on the preferred one.
Primary Key: The primary key values of the record, in column order as column1_name:column1_value,column2_name:column2_value,column3_name:column3_value and so on.
Sensitive data in certain columns, rows, cells, or whole tables may be blinded and require special privileges to view. If you have the required privileges, you can choose to see the real data when you first open the Listings page. You can use the padlock icon to toggle between viewing blinded data and viewing the masking values (or, in the case where a whole table or row is blinded, not seeing the table or row at all). The system records each blind break in a non-modifiable audit trail.
Users who do not have the privileges required to see blinded data do not see either the message upon opening the page or the padlock icon.
There are four icons for exporting data:
Export All to Excel generates an .xls file that includes all data that satisfies the current filters (if any).
Export Current Page to Excel generates an .xls file that includes the currently visible data.
Export All to CSV generates a comma-delimited text file that includes all data that satisfies the current filters (if any).
Export Current Page to CSV generates a comma-delimited text file that includes the currently visible data.
Select a data point and click the View Data in InForm icon. The InForm Login page opens. After you log in, you see the data in context, with access to comments and the audit trail.
If the selected data point has more than one source data point, the system displays the one designated as the preferred data source.
Note:
The InForm URL must be defined in the InForm configuration for the current data model and lifecycle.
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