1. Data Review Guide
  2. Review and act on discrepancies

3 Review and act on discrepancies

How do I create a discrepancy?

Go to Home, then Icon shows sheets of paper with text.Data Management, then Data Review, then Listings. See "Create discrepancies" for details.

Text Show me how! is a video link. Show me how!

Tip:

In Release 2.4.8 there are two Discrepancies pages, one old and one new.

Reach the new one by navigating to Icon shows sheets of paper with text.Data Management, then Discrepancies. This page has an enhanced user interface.

Reach the old one by navigating to Icon shows sheets of paper with text.Data Management, then Data Review, then Discrepancies. This page has more powerful filter and sorting capabilities.

Parent topic: Review and act on discrepancies

Find discrepancies

There are two ways to find discrepancies that can be used together or separately: the filters in the left pane and the fields at the top.

Parent topic: Review and act on discrepancies

Use the quick filters on the left pane

These look for the exact values you enter.

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.

  2. Select Discrepancies.

  3. In the left panel, search for any combination of the following: Clinical Data Model, Listing, Site, Subject, Visit, Discrepancy State.

    Start at the top and work down. Your choices in the lower fields are limited by the values in the upper fields. You can select more than one value by clicking in the field again.

  4. Click Apply.

  5. (Optional) To save these criteria for future use, click Save, name the filter, and click Save and Apply.

    Tip:

    Saving a filter allows you to modify it one criterion at a time, saving after each change.

  6. Use the search fields at the top to add filter criteria.

    Tip:

    If you need more granular filters, go to the old Discrepancies page. See Use filters to find data and discrepancies.

    1. Click the Icon is a house.Home icon at the top of the page.

    2. Click the Icon shows sheets of paper Data Management icon at the top of the page.

    3. Click Data Review.

    4. Click the Discrepancies tab.

    5. Click the Icon shows a funnel.Filter icon.

To clear the filters, click Clear.

To view data after clearing, click Apply, without filters or with different ones.

Parent topic: Find discrepancies

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 quick filters that find only the exact value entered.

  • If there are quick 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 quick filters in effect, the system searches across all discrepancies.

    Tip:

    To see which quick filters are in effect, click the down arrow in the Icon is a blue block labeled Filters:On. Filter: ON indicator at the top of the page.

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.

  2. Select Discrepancies.

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

  4. Enter a value in the text box.

  5. Click the Icon is a magnifying glass.Search icon.

    Tip:

    If you need more granular filters, go to the old Discrepancies page. See "Use filters to find data and discrepancies".

    1. Click the Icon is a house.Home icon at the top of the page.

    2. Click the Icon shows sheets of paper Data Management icon at the top of the page.

    3. Click Data Review.

    4. Click the Discrepancies tab.

    5. Click the Icon shows a funnel.Filter icon.

    To clear, remove the value and click Refresh in the upper-right corner.

Parent topic: Find discrepancies

Act on a discrepancy

Parent topic: Review and act on discrepancies

Change the state or send to InForm or another system

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.
  2. Select Discrepancies.
  3. Find discrepancies using the filters on the left and top of the page.
  4. Select one or more discrepancies.
  5. From the Manage Discrepancies drop-down, select the action to take. Actions are listed only if they are valid for all selected discrepancies.

    In the right panel, either select or enter a reason for your change.

    Tip:

    If you do both, only the selected reason is saved.

  6. Click Submit.

Parent topic: Act on a discrepancy

Add a comment

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.
  2. Select Discrepancies.
  3. Find discrepancies using the filters on the left and top of the page.
  4. Select one discrepancy.
  5. In the right panel, click Add Comment.
  6. Enter the comment and click Submit.

Parent topic: Act on a discrepancy

Change discrepancy text or category

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.
  2. Select Discrepancies.
  3. Find discrepancies using the filters on the left and top of the page.
  4. Select one discrepancy.
  5. In the right panel, click Edit.
  6. Edit the discrepancy text and/or select a new category.
  7. Click Submit.

Parent topic: Act on a discrepancy

Export discrepancies on lab data

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

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.
  2. Select Discrepancies.
  3. Filter for the lab's data model and your other criteria in the filters on the left and top of the page. See Find discrepancies.
  4. If you want to export only selected discrepancies, select the discrepancies.
  5. From the Export drop-down, select an option to export:

    • All to Excel

    • All to CSV

    • Selected to Excel

    • Selected to CSV

    The system exports the data to a file and asks you where to save it.

Parent topic: Act on a discrepancy

See more information about a discrepancy

Parent topic: Review and act on discrepancies

View the full record containing a discrepancy

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.

  2. Select Discrepancies.

  3. Find discrepancies using the filters on the left and top of the page.

  4. Select one discrepancy.

  5. From the View drop-down on the right, select Full Record.

    To see a particular column:

    1. Enter part of its name in the Search field.

    2. Click the Search icon.

  6. (Optional) Select Show Only Changes to see only items with different current and original data values.

Parent topic: See more information about a discrepancy

View the record in its source system

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.
  2. Select Discrepancies.
  3. Find discrepancies using the filters on the left and top of the page.
  4. Select one discrepancy.
  5. From the View drop-down on the right, select Data in System.
  6. When the source system opens, log in.

Parent topic: See more information about a discrepancy

View the discrepancy in its source system

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page.
  2. Select Discrepancies.
  3. Find discrepancies using the filters on the left and top of the page.
  4. Select one discrepancy.
  5. From the View drop-down on the right, select Discrepancy in System.
  6. When the source system opens, log in.

Parent topic: See more information about a discrepancy

FAQs

Parent topic: Review and act on discrepancies

Acting on a discrepancy FAQs

Parent topic: FAQs

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

Parent topic: FAQs

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

Parent topic: FAQs

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

Parent topic: FAQs

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.

Parent topic: TMS discrepancy FAQs

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.

Parent topic: TMS discrepancy FAQs

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.

Parent topic: TMS discrepancy FAQs

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.

Parent topic: TMS discrepancy FAQs

Review and act on discrepancies in the old UI

Parent topic: Review and act on discrepancies

How do I create a discrepancy?

Go to Icon shows sheets of paper with text.Data Management, then Data Review, then Listings. See Create discrepancies for details.

Text Show me How! is a video link. Show me how!

Parent topic: Review and act on discrepancies in the old UI

Act on a discrepancy

You apply actions to discrepancies to move them from one state or tag value to another and/or to send them to InForm or to a spreadsheet to be sent to a lab. See the following for details.

Parent topic: Review and act on discrepancies in the old UI

Apply an action to change the state or send to InForm
  1. Click the Data Management icon Icon shows sheets of paper at the top of any page except the new Discrepancies page.
  2. Select Data Review.
  3. Select the Discrepancies tab.
  4. Select one or more discrepancies.

    Tip:

    See Create a new filter or Use or modify existing filters for help finding specific discrepancies.

  5. Click the Actions drop-down and select the action you want to apply. The list includes all actions that are valid for all the selected discrepancies; for example:

    • Open Discrepancy

    • Cancel Discrepancy

    • Close Discrepancy

    • Send to InForm

    Tip:

    To send a discrepancy to a lab, use Export to Excel and manually send the spreadsheet to the lab. See Export discrepancies for a lab.

  6. In the pop-up window, provide a reason for the change. Do either:

    • Select a reason from the list.

    • Enter a reason.

      Tip:

      If you select a reason and enter your own reason, only the selected reason is sent to the source system. To send your own text, do not select a reason.

  7. Click OK.

See InForm query and discrepancy FAQs, Lab data discrepancy FAQs, and TMS discrepancy FAQs.

Parent topic: Act on a discrepancy

Add a comment to a discrepancy
  1. Click the Data Management icon Icon shows sheets of paper at the top of any page except the new Discrepancies page.
  2. Select Data Review.
  3. Select the Discrepancies tab.
  4. Select a discrepancy, or select multiple discrepancies to apply the same comment to all of them.
  5. Click the Icon shows a cartoon talk bubble.Add Comment icon.
  6. Enter a comment.
  7. Internal Comment? Leave this field blank unless the discrepancy originated in Oracle Thesaurus Management System (TMS).

    If the discrepancy is from TMS:

    • If selected, the comment has no effect in TMS.

    • If not selected, the system changes the discrepancy's status to TMS EVALUATION and TMS autoclassification runs on the source term during the next transformation job.

  8. Click OK.

Parent topic: Act on a discrepancy

Edit discrepancy text
  1. Click the Data Management icon Icon shows sheets of paper at the top of any page except the new Discrepancies page.
  2. Select Data Review.
  3. Select the Discrepancies tab.
  4. Select a discrepancy.
  5. Click the Icon shows a pencil.Edit icon.
  6. Do one or more of the following:

    • Discrepancy: Edit the text describing the problem with the data or action required.

      Tip:

      If the discrepancy has been sent to InForm, you cannot edit the text.

    • Category: Select a category to apply to the discrepancy. You can filter discrepancies by category.

    • Action: See Apply an action to change the state or send to InForm.

    • Allow Auto Close: (Appears only for discrepancies created by validation checks.) If data is updated so it no longer meets validation check criteria:

      • If selected, the validation check closes the discrepancy.

      • If unselected, the discrepancy must be closed manually.

    • Select a Reason for Action from the drop-down list or enter your own reason in the text box.

  7. Click OK.

Parent topic: Act on a discrepancy

Export discrepancies for a lab

Click the Icon shows a folder paper with an X and an arrow.Export to Excel icon to generate an .xls file that includes all discrepancies that meet the current filter criteria, even if they are not visible on the screen.

You can then manually send the spreadsheet to a source lab. Lab personnel can respond or modify the underlying data item and load the changes into DMW.

Parent topic: Act on a discrepancy

See more information about a discrepancy

Parent topic: Review and act on discrepancies in the old UI

View discrepancy details
  1. Click the Data Management icon Icon shows sheets of paper at the top of any page except the new Discrepancies page.
  2. Select Data Review.
  3. Select the Discrepancies tab.
  4. Select one discrepancy.
  5. The Details pane for the selected discrepancy is on the bottom left. It includes:

  • Subject

  • Visit

  • Discrepancy: Discrepancy text. You can edit this by clicking the Icon shows a pencil.Edit icon. You cannot edit text for discrepancies that have been sent to InForm.

  • Table: The database table that contains the discrepant value.

  • Model: The clinical data model that contains the data value against which the discrepancy was originally created.

    Note:

    If the model is InForm, the discrepancy originated as a query in InForm.

  • Item: The table column that contains the discrepant value.

  • Original Value: The original discrepant data value.

  • State: The current discrepancy state: Candidate, Open, Cancelled, Answered, or Closed. To change it, select Actions from the right-click or drop-down list.

    Tip:

    By default, Closed and Cancelled discrepancies are not displayed. To display them, use a States and Tags filter. See Discrepancy States and Tags filter.

  • Days in State

  • Category: The category assigned to the discrepancy, if any. You can filter by category. To change it, click the Icon shows a pencil.Edit icon.

  • Created

  • Modified

  • Tag: The tag assigned to the discrepancy, if any. Some actions apply tags.

  • New Data: If Yes, the data value has been changed in the source system and the discrepancy has not been reviewed in DMW since then. When you or someone else clicks Display Full Record, the system considers it reviewed and sets this value to No. You can also set it to No.

  • View Query in InForm: When you click this icon, the InForm Login page opens. After you log in, the system displays the selected query in context.

  • View Data in InForm: When you click this icon, the InForm Login page opens. After you log in, the system displays the underlying data in context.

View discrepancy history
  1. Click the Data Management icon Icon shows sheets of paper at the top of any page except the new Discrepancies page.
  2. Select Data Review.
  3. Select the Discrepancies tab.
  4. Select one discrepancy.
  5. The History pane for the selected discrepancy is on the bottom right.
  6. Click the Icon is a near circular arrow. Refresh icon to view any changes that have occurred since you selected the discrepancy or last refreshed.

The history of the discrepancy is displayed with the most recent change at the top.

View the full record containing a discrepancy
  1. Click the Data Management icon Icon shows sheets of paper at the top of any page except the new Discrepancies page.
  2. Select Data Review.
  3. Select the Discrepancies tab.
  4. Select one discrepancy.
  5. On the bottom right, select the Display Full Record tab.
  6. Click the Icon is a near circular arrow. Refresh icon to view any changes that have occurred since you selected the discrepancy or last refreshed.

The internal column CDR$SKEY displayed at the bottom contains the primary key values of the record separated by tildes (~). DMW uses this value to trace data lineage.

View a discrepancy in its source system

If a discrepancy was created on data from InForm or another EDC clinical data system, then sent to the system, and then data reloaded from that system, you can open the external system and view the discrepancy/query in context there.

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page except the new Discrepancies page.
  2. Select Data Review.
  3. Select the Discrepancies tab.
  4. Select one discrepancy.
  5. In the Details pane, click the View Query in External Source icon near the bottom.
View data in its source system

To view data in context in InForm or another EDC clinical data system:

  1. Click the Data Management icon Icon shows sheets of paper at the top of any page except the new Discrepancies page.
  2. Select Data Review.
  3. Select the Discrepancies tab.
  4. Select one discrepancy.
  5. In the Details pane, click the View Data in External Source icon at the bottom.

Show blinded data

If you have special privileges, you can choose to see sensitive, blinded data instead of masking values. The system tracks the times you view blinded data.

  • Icon shows an open padlock.Show Sensitive Data is displayed by default. Click this icon to show blinded data.

  • Icon shows a locked padlock. Hide Sensitive Data is displayed when you have chosen to display blinded data. Click this icon to hide blinded data.

Parent topic: Review and act on discrepancies in the old UI