Discrepancy Management

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Preston Shelton
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1 Discrepancy Management Oracle Clinical Discrepancy Statuses IN OC RDC Discrepancies tab: While working in OC RDC Classic, you will encounter discrepancies with various assigned statuses on the Discrepancies task tab. The statuses you will see and a brief explanation are provided below. Note that the screen shots provided are from the perspective of a CRA. The List of Discrepancies tab is the central location for working with the discrepancies associated with one CRF. It provides various features: provides you with an overview of discrepancy information about that CRF allows you to initiate an action on a discrepancy allows you to enter informative text about a discrepancy allows you to generate a new discrepancy, either for: o the entire CRF, or o a single datapoint view the history associated with a discrepancy. Discrepancy not reviewed by user: This is the Unreviewed status of a discrepancy that requires site personnel review i.e. coordinator or Investigator. When logged in as a CRA or other study team member, you will see these discrepancies in yellow as Other Discrepancy. They will appear Red to the site as Open Discrepancy. INV Review: This is the status of a manually assigned discrepancy that requires site personnel review i.e. coordinator or Investigator. When logged in as a CRA or other study team member, you will see these discrepancies in yellow as Other Discrepancy. They will appear Red to the site as Open Discrepancy. CRA Review This is the status of a query that requires PPD review when you are logged in as a CRA. You will see these in red as Open Discrepancy. They will appear Yellow to the site as Other Discrepancy. Note that if the discrepancy was raised as a manual discrepancy by another department e.g. by Data Management or PVG and the site has responded to it and sent it back to PPD the status bar will still read CRA review (there is no option for the site to send this query to DM for review or to PVG for review). You should work with DM and PVG to determine whether the query can be closed and by whom. CLOSED These are discrepancies which have been manually closed by the CRA, i.e. manual discrepancies or automatic discrepancies which were first resolved by the investigator and for which the CRA has accepted the resolution text. Version 1.1 Page 1 of 16

Discrepancy Statuses IN OC RDC Classic Discrepancies task tab: TMS IN PROGRESS (relates to PPDs Data Management coding system) These discrepancies are reviewed by data management, who often works

2 Discrepancy Statuses IN OC RDC Classic Discrepancies task tab: TMS IN PROGRESS (relates to PPDs Data Management coding system) These discrepancies are reviewed by data management, who often works with Pharmacovigilance/Safety, or other coding resources to resolve the discrepancies. These discrepancies do appear on the ecrf but should be addressed ONLY by Data Management. The ecrf cell icon and patient icon on the Activity List will display the appropriate discrepancy color relative to a users role, i.e. these will be YELLOW to the CRA and site but RED to Data Management. If the terms cannot be resolved or coded against the dictionaries, data management can set the query status to INV Review. If this occurs, the discrepancy would then be an active discrepancy, appearing to the site as RED for their action. DM REVIEW or DM LAB REVIEW These are discrepancies that are set for data management to review. Most commonly, TMS queries would be set to DM REVIEW after someone from coding has reviewed the queries and the terms are not able to be coded to any medical dictionary. Site users and CRAs will see these discrepancies as YELLOW since they do not require their action. Sites and CRAs do not have the option to change a discrepancy status to DM Review. ADDITIONAL DISCREPANCY STATUSES IN DETAILED RDC QUERY TRACKING REPORT: When running the Detailed RDC Query Tracking Report, one of the standard reports available in OC RDC to all users, some additional query statuses can appear. The statuses and a brief explanation are provided below. OBSOLETE These are discrepancies that have been closed automatically by OC RDC. These discrepancies were automatically closed during batch validation, etc., due to a change in the data that made the discrepancy obsolete. Version 1.1 Page 2 of 16

3 Access By default, the List of Discrepancies tab is displayed whenever you click the Discrepancies task tab. If focus is elsewhere within the Discrepancy task tab, you can access the List of discrepancies by selecting its tab. Components The List of Discrepancies tab provides a substantial amount of information about each discrepancy associated with a CRF. Components of the List of Discrepancies tab Seq Text Label Type Description Field Field Sequence number a number that is assigned to each discrepancy that is based on its current status, its timestamp, and the CRF datapoint with which it is associated. An editable field that describes the discrepancy. You can double-click the field to display the Field Editor window, if you wish to draft text in it; otherwise, you can simply type the description directly in the field. Status Field A descriptive field that displays the current status of the discrepancy. Comments Action Resolution Resolution Comment Field Dropdown list Field Field An editable text box that displays the current comment text associated with a given discrepancy. You can double-click the field to display the Fiedl Editor window, if you wish to draft text in it; otherwise, you can simply type the description directly in the field. A drop-down list that gives you access to the set of Discrepancy actions available. An informative field that displays the action that was taken for a discrepancy that resulted in its resolution. An editable field that contains text that describes the resolution of the discrepancy. You can double-click the field to display the Field Editor window, if you wish to draft text in it; otherwise, you can simply type the description directly in the field. New Button Initiates the process of creating a new discrepancy. History Button Opens the Discrepancy History window, which lists the changes to the currently selected discrepancy. Ordering of discrepancies in the list A set of criteria determines the sequence number of each discrepancy in the List of Discrepancies tab. It is based on the current discrepancy status and the location of the datapoint with which each discrepancy associated. As the status of a discrepancy changes, as well as the status of other discrepancies, and other discrepancies are added to the CRF, the sequence number associated with a discrepancy changes. Version 1.1 Page 3 of 16

Example of a selected discrepancy list List tab Shows all discrepancies for an ecrf page Text Status Seq New History View resolution and resolution coments in the history window.

4 Example of a selected discrepancy list List tab Shows all discrepancies for an ecrf page Text Status Seq New History View resolution and resolution coments in the history window. Comments Action Individual Discrepancy tab For each discrepancy listed in the List of Discrepancies tab, there is a corresponding individual tab, which displays the complete set of information related to a single discrepancy. Access To access an individual discrepancy tab, click the appropriate tab. When you do this, the tab you select is displayed "on top," and you can view or work with that discrepancy. Components of an individual discrepancy tab The components of an individual discrepancy tab are identical for all statuses. The table below lists and describes each of the components that are present on each tab. Version 1.1 Page 4 of 16

5 Components of an Individual Discrepancy Tab Tab Title Label Type Description Info Text The label that is displayed on the tab, it includes the current sequence number and the discrepancy status. Text Info Text The error message that describes the discrepancy. Status Info Text A descriptive field that displays the current status of the discrepancy. Id Action History Resolution Comments and Reason Comments Resolution Comments Variable Value Info Text Drop-down list Button Info Text and Text Field Text Field Info Text Data field Data field An internal identification number that is assigned to the discrepancy by Oracle Clinical. A drop-down list that gives you access to the set of Discrepancy actions that are designated for the study. Opens the Discrepancy History window, which lists the changes in status that have occurred to the current discrepancy. The Resoultion Reason text field displays the reason that was selected when the discrepancy was resolved. The Resolution Comments text box displays the comment that was included when the discrepancy was resolved. An editable text box that displays the current discrepancy comment. You can type directly in the field or double-click in the text box to open the Field Editor window. A field that displays the comment that was included with the resolution reason. A field that displays one variable that is associated with the discrepancy. (Multivariate discrepancies only) A field that displays the current value of the corresponding variable. (Multivariate discrepancies only) Version 1.1 Page 5 of 16

6 Select a discrepancy In order to work with a discrepancy from the List of discrepancies tab, you must first select it. To select a discrepancy, click on the appropriate sub-tab for that discrepancy. Example of a selected discrepancy Tab Title Text Action History Status Id Comments Variable Value Resolution Comments Resolution Comments and Reason Version 1.1 Page 6 of 16

generated by another user group such as Data Management or PVG should not be closed by you. Follow your study specific guidelines on who should close them.

7 Step by Step Instructions for Discrepancy Resolution in Classic Mode Recall that discrepancies requiring your attention will be red. You will have two options when reviewing discrepancies: Route the discrepancy back to the site for further clarification Close the discrepancy if appropriate (Manual discrepancies that have been generated by another user group such as Data Management or PVG should not be closed by you. Follow your study specific guidelines on who should close them.) Routing a discrepancy back to the site: Step Procedure Step 1 To open the ecrf with open discrepancies, click on the red ecrf icon in the main screen. Click on the Discrepancies tab to view the list of discrepancies. Select the sub-tab to view the individual discrepancy. Step 2 Review the discrepancy and determine what action needs to be taken. In this example, we are going to route the discrepancy back to the site for further clarification of the patient s race. Version 1.1 Page 7 of 16

Step Step 3 Procedure Click on the Action drop down list and select Send to Investigator.

Delete the current comment, note that all deleted comments will be viewable in the window.

8 Step Step 3 Procedure Click on the Action drop down list and select Send to Investigator. Step 4 The Internal comments for Discrepancy window appears. Delete the current comment, note that all deleted comments will be viewable in the window. Step 5 Enter the appropriate comment requesting the clarification needed to correct the data and close the discrepancy. Step 6 Click the Save button to close the Internal comments for Discrepancy window. Note that the discrepancy status and sequence number has changed. Version 1.1 Page 8 of 16

Closing a discrepancy: Step Step 1 Procedure Open the ecrf. Click on the Discrepancies tab and open the discrepancy sub-tab that will be reviewed and closed.

In this view, you will be able to view the site comments, manual discrepancy comments.

9 Closing a discrepancy: Step Step 1 Procedure Open the ecrf. Click on the Discrepancies tab and open the discrepancy sub-tab that will be reviewed and closed. Step 2 Double click in the comments field to open the Editor window to view the entire comment. In this view, you will be able to view the site comments, manual discrepancy comments. If you scroll to the data field questioned in the discrepancy, you will be able to view all of the information needed to determine if you can close the discrepancy. Site Correction Site Response Manual Discrepancy Request Ensure that the site has made the corrections on the ecrf as noted in the Editor window. Version 1.1 Page 9 of 16

Step Procedure Step 3 Click on the Action drop down list. To close the discrepancy, select Close resolved. Step 4 The Resolution Reason window appears.

10 Step Procedure Step 3 Click on the Action drop down list. To close the discrepancy, select Close resolved. Step 4 The Resolution Reason window appears. The data had been changed by the site therefore the correct resolution is Data value changed. Disc no longer applicable. 7. From the Resolution drop down list, select the Data value changed. Disc no longer applicable. Note: Comments may be added if appropriate. Step 5 Click Save Discrepancy has been closed, fields are greyed and status updated. Reminder: Discrepancies that have been generated by another user group should not be closed unless indicated by your project specific guidelines for discrepancy management. Version 1.1 Page 10 of 16

Step Procedure Step 1 Click in the Physical Assessment data field for Skin (blue highlight) Step 2 To create a manual discrepancy, you

11 Generating a manual discrepancy: Assmune that during SDV, the medical record indicated that a rash was noted on the Physical Exam (PE). The ecrf data recorded indicates that the PE for Skin was normal. A discrepancy will need to be created to reflect the source documents. Step Procedure Step 1 Click in the Physical Assessment data field for Skin (blue highlight) Step 2 To create a manual discrepancy, you will use the Discrepancy (manual) icon in the tool bar. Click on the Discrepancy (manual) icon Discrepancy (manual) Version 1.1 Page 11 of 16

Step Procedure The manual discrepancy window will open. The title bar indicates the data field that the discrepancy will be related to (Comment for Question Normal/Abnormal/Not Done).

12 Step Procedure The manual discrepancy window will open. The title bar indicates the data field that the discrepancy will be related to (Comment for Question Normal/Abnormal/Not Done). Message text field Comment Reason field Comments field Do not enter text in this field. Action field Step 3 In the Comment Reason field, click on the drop down list and select DE Comment from the list. Version 1.1 Page 12 of 16

Step Step 4 Procedure In the Message field, type the clarification that will needed to made by the site. In this example, the following error message was added: MANUAL CRA.

Consider adding this to the Physical Assessment for Skin, indicating that the assessment was abnormal and adding Rash to the Specify if Abnormal field.

13 Step Step 4 Procedure In the Message field, type the clarification that will needed to made by the site. In this example, the following error message was added: MANUAL CRA...As noted in the source documents, the Physical Exam performed on 28 Feb 2006 indicated a rash. Consider adding this to the Physical Assessment for Skin, indicating that the assessment was abnormal and adding Rash to the Specify if Abnormal field. Do not enter comments in the Comments (optional) field. Refer to your project specific guidelines for naming conventions when generating a manual discrepancy. In this example, the naming convention to start all manual discrepancies created by the CRA is Manual CRA Type your discrepancy in the Message field or you can click on this icon to open the Comment message window to view entire text or type your discrepancy in this window. Step 5 In the Action: drop down list select Send to Investigator to route the discrepancy to the site. Version 1.1 Page 13 of 16

14 Step Step 6 Procedure The Internal Comment window will appear. DO NOT enter comments in this field. Click OK or Cancel to close this window. Step 7 Click OK to close the discrepancy window. Version 1.1 Page 14 of 16

After completing the above steps for generating a manual discrepancy, the view below indicates that you have successfully generated a manual discrepancy.

15 After completing the above steps for generating a manual discrepancy, the view below indicates that you have successfully generated a manual discrepancy. The discrepancy appears in the Discrepancies tab list. The yellow discrepancy icon appears in the DEW tab indicating an active discrepancy that needs to be addressed by the site. The data field is now highlighted in yellow with blue text indicating there is an outstanding discrepancy. Reminder: Yellow fields with blue text indicate a discrepancy that has been generated on data entry or manually. Version 1.1 Page 15 of 16

16 Process Flows Oracle Clinical Data Entry, Monitoring and Discrepancy Flow The following diagram highlights the RDC process for data entry, monitoring and discrepancy flow. Investigator Site Performs Data Entry into ecrf System Generated Discrepancies (during data entry and upon save of ecrf) Discrepancies Generated Investigator site makes corrections on ecrf Validation Checks (run automatically every night, or when initiated by site users or CRAs) Discrepancies Generated Manual Discrepancies (appear immediately after they have been saved) Discrepancies Generated Investigator site makes corrections on ecrf or comments on data entered Changes Rejected CRA reviews changes or comments on data Changes Accepted or No Change Required CRA creates discrepancies ecrf Corrections /Clarifications Discrepancy Closed CRA Performs SDV ecrf Data Correct CRA Validates ecrf (Verification) Investigator Approves ecrf Note: Additional discrepancies may be raised by PVG or DM during review of data. These discrepancies would require site response, and a reverification and reapproval of any changed ecrfs, following the process outlined in the flow diagram. Version 1.1 Page 16 of 16

Discrepancy Statuses In OC RDC PDF Discrepancy Management Window:

Discrepancy Statuses In OC RDC PDF Discrepancy Management Window: While working in OC RDC, you will encounter discrepancies with various assigned statuses on the Discrepancy Management window. The statuses