3 Review and act on discrepancies

The section contains the following topics:

• How do I create a discrepancy?
  
• Find discrepancies
  
• Act on a discrepancy
  
• See more information about a discrepancy
  
• FAQs
  

How do I create a discrepancy?

You create a discrepancy on a data item by selecting a study and clicking Data Management in the navigation bar. Then, select Listings from the drop-down menu. You can then select a listing, locate the data item with the possible discrepancy, right-click on it, and select Create Discrepancy. For full details on creating a discrepancy, see Create discrepancies.

You can also see this video for details:

Find discrepancies

You can find particular discrepancies using one or both of the following methods:

• Filters in the left panel (use one or more fields, build an advanced filter with a formula, or both)
• Search fields at the top of the table

See the following sections for details:

• Use filters in the left panel
  
• Use the search fields at the top
  
• Show blinded data
  

Use filters in the left panel

To find discrepancies, use the filter fields in the left panel. You can use one or more fields, build an advanced filter formula, and save a favorite filter for later use.

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 Discrepancies from the drop-down menu.

3. In the left panel, do one or more of the following:

   • Select a saved filter from the Saved Filters fields drop-down menu, if available. The fields used in the filter automatically populate.
   • Click Advanced Filters to open a text box. Click inside the box to open a drop-down menu, select a filter item and start building your formula using the appropriate operators. The criteria you select determines what additional items you can access. See Advanced Filters for more information.
   • Click in one or more of the following fields to enter or select the quick filter criteria you want to use (with or without an advanced filter formula). Use the scroll bars to see all your choices:
     1. Model: Lists the models in the study (only shown through Discrepancies page).
     2. Listing: Lists the listings for the model you selected (only shown through Discrepancies page).
     3. Country: Lists the countries of the study or listing (depending if you accessed the filters from Listings or Discrepancies).
     4. Site: Lists the location of where the study or listing was done.
     5. Subject: Lists the available subject IDs.
     6. Visit: Lists the available names of visits.
     7. Discrepancy State: Lists the available discrepancy states. You can select Answered, Cancelled, Candidate, Closed, Open.

        Tip:

        By default, you cannot see cancelled or closed discrepancies. You must apply the Discrepancy State filter of Cancelled or Closed to see them.

     8. Discrepancy Tag: Lists the available discrepancy tags (for example, ClosedWithAnswer, NeedsDMReview, ClosedAsIs).
4. If your account includes the appropriate privileges and you need to show blinded data, select Show Blinded Data and click Yes when prompted. (The system tracks the number of times you view blinded data.)
5. If you want to keep displaying the filtered data, select Keep the Filter in effect.
6. Click Apply.
7. (Optional) To save the filter criteria for future use, click Save, name the filter, and click Save and Apply. If you want to use this filter as a template to create a new filter, click Create New and repeat these steps.

   Tip:

   Saving a filter allows you to modify it one field at a time, saving after each change. To edit or delete filters, see Use or modify existing filters or Delete a filter. To make a filter public, see Create a public filter.
8. To clear the filters, click Clear. To view the data after clearing the filters or creating a new filter, click Apply.

Use the search fields at the top

You can enter a partial value here to find all records that contain that value. For example, if you search for Subject ID=CA, you find all subject IDs that contain CA, unlike the filters that find only the exact value entered.

• If there are filters in effect when you search in these fields, the system applies the filters and searches on these values within the filter results.

• If there are no filters in effect, the system searches across all discrepancies.

  Tip:

  To see which filters are in effect, click the down arrow in the Filter: ON indicator at the top of the page.

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 Discrepancies from the drop-down menu.

3. In the drop-down list above the discrepancies table, select what to search on, for example: Category, Datasource, Days since last state change, Validation check. The choices depend on the columns your organization uses.

4. Enter a value in the text box.

5. Click the Search icon.

6. To clear the filters, remove the value entered in the text box and click Refresh from right of the navigation bar.

Show blinded data

As described in Use filters in the left panel, you can select Discrepancies from the Data Management menu to drill down into the data and locate specific items. If your account includes the appropriate privileges and you need to show or hide blinded data, do one of the following:

• To show blinded data, select Show Blinded Data from the Filter panel on the left and click Yes when prompted. (The system tracks the number of times you view blinded data.)
• To hide blinded data, clear the Show Blinded Data field and click Yes when prompted.

Note:

If you selected a listing instead of discrepancies and clicked Yes when prompted to access blinded data (if available), the Show Blinded Data field appears selected already in the Filters panel (tab).

Act on a discrepancy

This section describes how to complete the following tasks:

• Change the state or send to InForm or another system
  
• Add a comment
  
• Change discrepancy text or category
  
• Export discrepancies on lab data
  

Change the state or send to 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 Discrepancies from the drop-down menu.
3. Find the discrepancies you need to locate using the filters on the left panel or the top of the page. (See Find discrepancies for details on using the filters.)
4. Select one or more discrepancies.
5. From the Manage Discrepancies drop-down, select the action to take (for example, Ready to Send to InForm). The drop-down list only includes valid actions for the discrepancies you selected. A new dialog box with the name of the action you selected opens in the right panel.
6. In the Reason field, select a reason from the drop-down list. Or, enter reason in the Comment field instead. (If you select a reason and enter a comment, Oracle DMW only saves the reason.
7. Click Submit.

Add a comment

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 Discrepancies from the drop-down menu.
3. Find the discrepancies you need to locate using the filters on the left panel or the top of the page. (See Find discrepancies for details on using the filters.)
4. Select one discrepancy.
5. In the right panel, click Add Comment.
6. Enter the comment and click Submit.

Change discrepancy text or category

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 Discrepancies from the drop-down menu.
3. Find the discrepancies you need to locate using the filters on the left panel or the top of the page. (See Find discrepancies for details on using the filters.)
4. Select one discrepancy.
5. In the right panel, click Edit.
6. Edit the Discrepancy field, Category field, or both. You can also select or clear the Allow Auto Close option. (You cannot change the state of the discrepancy.)
7. Click Submit.

Export discrepancies on lab data

To send discrepancies to a lab, create a file, and email it manually, follow these steps.

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 Discrepancies from the drop-down menu.
3. Find the discrepancies you need to locate using the filters on the left panel or the top of the page. (See Find discrepancies for details on using the filters.)
4. If you want to export only selected discrepancies, select the discrepancies.
5. Select one of the following from the Export drop-down list:

   • All to Excel

   • All to CSV

   • Selected to Excel

   • Selected to CSV

   The system exports all or selected data to a Microsoft Excel or CSV file and prompts you to save it.

See more information about a discrepancy

This section contains the following topics:

• View the full record containing a discrepancy
  
• View the record in its source system
  
• View the discrepancy in its source system
  

View the full record containing a discrepancy

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 Discrepancies from the drop-down menu.

3. Find the discrepancies you need to locate using the filters on the left panel or the top of the page. (See Find discrepancies for details on using the filters.)

4. Select one discrepancy.
5. From the View drop-down in the top section of the right panel, select Full Record to open the Full Record dialog box.
6. To see a particular column, enter part of the column name in the Search field and click to locate it.
7. (Optional) Select Show Only Changes to see only items with different current and original data values.
8. Click to close the Full Record dialog box.

View the record in its source 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 Discrepancies from the drop-down menu.
3. Find the discrepancies you need to locate using the filters on the left panel or the top of the page. (See Find discrepancies for details on using the filters.)
4. Select one discrepancy.
5. From the View drop-down in the top section of the right panel, select Data in System.
6. When the source system opens, log in.

View the discrepancy in its source 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 Discrepancies from the drop-down menu.
3. Find the discrepancies you need to locate using the filters on the left panel or the top of the page. (See Find discrepancies for details on using the filters.)
4. Select one discrepancy.
5. From the View drop-down in the top section of the right panel, select Discrepancy in System.
6. When the source system opens, log in.

FAQs

• Acting on a discrepancy FAQs
  
• InForm query and discrepancy FAQs
  
• Lab data discrepancy FAQs
  
• TMS discrepancy FAQs
  

Acting on a discrepancy FAQs

• Can I take an action on multiple discrepancies at once?
  
• Why don't I see the action I want to apply?
  
• Can I send discrepant data items to multiple sources?
  
• Why can't I send a particular data item to another source?
  

Can I take an action on multiple discrepancies at once?

Yes, but you should select discrepancies that are all in the same state. The discrepancies may also need the same tag depending on how your company uses the system, and may need to be from the same data source. The system only displays actions that are valid for all the selected discrepancies.

Why don't I see the action I want to apply?

If you selected multiple discrepancies, the system displays only actions that apply a valid next state for all the selected discrepancies. If you select discrepancies that do not share a valid action, the system lists no actions. You must change your selection to a set of discrepancies that are in the same state. They may also need to have the same tag applied.

If you selected a single discrepancy and the discrepant data point is derived from multiple data values from different sources, the system uses the data source identified as on the preferred path in the transformation to determine which routing action to enable. If no action is available to send the discrepancy to the source you need, you may need to enter the discrepancy against the data point in the source data model.

Can I send discrepant data items to multiple sources?

If a single discrepant data item is derived from data in more than one source, you can only send the discrepancy to InForm if an InForm data item is designated as being on the preferred path. You can always filter and use Export to Excel for sending a discrepancy to a lab.

Why can't I send a particular data item to another source?

The system uses the preferred path source specified in the transformation or validation check to determine where you can send the discrepancy. If no action is available to send the discrepancy to the right source, you can go to the Listings page, change to the source data model, and create a discrepancy against the data item there.

Add a comment to the current discrepancy detailing what you did.

InForm query and discrepancy FAQs

• Can I change the state of a discrepancy that was loaded from InForm?
  
• Can I create a discrepancy in DMW on a data item that originated in InForm?
  
• Can I send a discrepancy to InForm?
  
• Why can't I open InForm and see a discrepancy there?
  
• What happens to the discrepancy after I send it to InForm?
  
• If I don't send the discrepancy to InForm, can InForm users act on the discrepancy?
  
• Before I send the discrepancy to InForm, can I act on it?
  

Can I change the state of a discrepancy that was loaded from InForm?

You can only move discrepancies/queries to the Answered state in InForm. You can close them in either system.

This is true no matter which system the discrepancy/query was created in.

Can I create a discrepancy in DMW on a data item that originated in InForm?

Yes. Validation checks can also create discrepancies on a data item originating in InForm.

Can I send a discrepancy to InForm?

Yes. When you send a discrepancy on an InForm data item back to InForm, you create a new query in InForm.

InForm does not accept discrepancies on data that is hidden in InForm. Any resolution must occur within DMW.

Why can't I open InForm and see a discrepancy there?

You have to wait until data has been reloaded from InForm after sending the discrepancy.

What happens to the discrepancy after I send it to InForm?

InForm users can act on the discrepancy using the same rules that apply to queries. InForm users can also correct the underlying data item.

Changes made in InForm are loaded into DMW during the next scheduled data load. The discrepancy is then "in" DMW and cannot be sent to InForm again, though updates made in DMW are sent to InForm.

If I don't send the discrepancy to InForm, can InForm users act on the discrepancy?

No. InForm users can change the underlying data item, and that change is loaded into DMW during the next scheduled data load, but they can't act on the discrepancy.

Before I send the discrepancy to InForm, can I act on it?

Yes. In DMW you can apply an action that changes the state of the discrepancy and must supply a reason for the change. The state change and reason for change are sent to InForm almost immediately.

Lab data discrepancy FAQs

• Can I create a discrepancy on a data item that originated in a lab?
  
• How do I send these discrepancies to the lab?
  

Can I create a discrepancy on a data item that originated in a lab?

Yes. Validation checks can also create a discrepancy on a data item that originated in a lab.

How do I send these discrepancies to the lab?

You can use Export All to Excel to export discrepancies to a spreadsheet and manually send them to the source lab. Lab personnel can then respond or change the underlying data item and load the changes into DMW, and you can act on the discrepancy in DMW.

When you use the Export All to Excel option to send discrepancies to a spreadsheet, all discrepancies that meet the current filter criteria are included, even if they are not visible on the screen.

TMS discrepancy FAQs

• What does it mean when a discrepancy's category includes "TMS"?
  
• What do the different TMS Discrepancy Categories mean?
  
• What should I do with a TMS discrepancy?
  
• Why is a query on a different item in InForm than in DMW?
  

What does it mean when a discrepancy's category includes "TMS"?

If your study is set up to use Oracle Thesaurus Management System (TMS) for coding source data to standard terminologies, or dictionaries, TMS processes designated data items with new or changed data during DMW transformation. If TMS is able to automatically code a designated source term to a dictionary term, it does so and derives specified data back to DMW.

TMS creates a discrepancy when it cannot automatically code a data item to a dictionary term.

What do the different TMS Discrepancy Categories mean?

• TMS in Progress prevents updates in DMW while the data item (term) awaits manual classification in TMS.

• TMS Evaluation means that the item or discrepancy has been updated either in the source system or in DMW, and triggers autoclassification on the term in TMS during the next transformation. No updates can be made in DMW while the category is TMS Evaluation.

• TMS DM Review means that the data manager should review the discrepancy in DMW.

• TMS Inv Review means that the discrepancy has been sent to InForm as a query for review by the investigator. The system also sends any subsequent updates to the discrepancy to InForm.

You can use a Discrepancy Categories filter to help process these discrepancies.

What should I do with a TMS discrepancy?

You can only review the discrepancy in DMW. TMS discrepancies must be resolved in either TMS or the source data system.

A TMS user can either:

• Classify the data item manually. TMS then closes the discrepancy and derives data to DMW.

• Send text to DMW as discrepancy text describing a problem with the data or an action required. For example, if the data item is "headache and nausea," the message could be "Split the term."

A source data system user can correct the term so that it can be classified in TMS.

Tip:

A discrepancy can be updated in the source system and in TMS at the same time. This may cause conflicts. For example, an InForm user might close a discrepancy thinking the term is a valid one while TMS does not recognize it. In this case, even though the Closed status is loaded into DMW, closing the discrepancy, TMS opens a new discrepancy when autoclassification fails.

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

This can happen if your study designer set up Coding Maps in Central Designer to purposefully attach a query to a different form item than the one it was raised on. This feature is intended for use with Central Coding.

If the same form item is set up for coding in TMS through DMW, when the discrepancy is sent to InForm the Coding Map routes the query to its mapped item.