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 and a brief explanation are provided below. Note that the screen shots provided are from the perspective of a CRA. Discrepancy not reviewed by user: This is the Unreviewed status of a discrepancy that requires site personnel review i.e. coordinator or Investigator. This is the initial status of a system generated discrepancy. 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. Version 1.1 Page 1 of 20

INV Review: This is the status of a manually assigned discrepancy or a system generated discrepancy that has been reviewed by the CRA and sent back to the site 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. Version 1.1 Page 2 of 20

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. Version 1.1 Page 3 of 20

TMS IN PROGRESS (relates to PPDs Data Management coding system) Oracle Clinical 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. 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 4 of 20

Discrepancy Management window The Discrepancy Management window is the primary location you use to add new discrepancies and work with existing discrepancies. It provides an interface that allows you to review and update all of the discrepancies associated with a response field or the current CRF section. It consists of an informational area, which provides context that you use to ensure you are working with the correct set of discrepancies, and a set of tabs. Access The system opens the Discrepancy Management window when the Discrepancy Mangement tool is active. For all users, they can click on the Discrepancy Management tool or use the right click on the mouse feature. General window components The set of components present in the Discrepancy Management window depend in part on the current context. The current context is determined by: the privileges associated with your user name the mode, either active or browse, of the CRF the status of the CRF. Components in the Discrepancy Management window Name Type Description Question Information Existing Discrepancy Detail Add Discrepancy or Add Section Discrepancy Window Section Tab Tab Provides information about the current CRF focus. One tab for each existing discrepancy associated with the response field and the CRF section. There are two types of tabs one to add a discrepancy to the response field, and one to add a section discrepancy. These tabs are not included in the window if you are not able to initiate a discrepancy or the CRF status precludes adding a discrepancy. Help Button Launch context-sensitive online help OK Button Records changes to any tab with pending changes, closes window. Cancel Button Discards pending changes, closes window. Version 1.1 Page 5 of 20

Discrepancy Management window - displaying Closed Discrepancy tab Question Information Add Section Discrepancy or Add Discrepancy Existing Discrepancy Help OK Cancel Question information section This section of the window provides information about the field that was used to access the Discrepancy Management window. It is comprised of the following non-editable fields: 1. Section the name of the CRF section with which the question is associated 2. Question the question label Version 1.1 Page 6 of 20

Tabs for adding a Discrepancy Just as there are two types of user-generated discrepancies, there are two types of tabs through which you can add a discrepancy. Because only one open manual discrepancy can be associated with a response value, the 'Add Discrepancy' tab is present only if there is not an existing user-generated discrepancy associated with the response. In contrast, the Add Section discrepancy tab is always displayed, since more than one discrepancy can be associated with a CRF section. Components in Add Discrepancy and Add Section Discrepancy tabs The components that comprise the Add Discrepancy and the Add Section Discrepancy tabs are identical. Each tab has a "Discrepancy Error Details" section, which the provides the means to initiate a discrepancy. Each also has a "Discrepancy Action" section, which provides the means to route or resolve the discrepancy as soon as you initiate it. Reason Name Type Description Error Message Drop-down list box Text box Provides a list of sponsor-defined reasons for adding the discrepancy. You must choose a selection when you add a discrepancy. Location for a user-supplied description of the discrepancy. You must choose a selection when you add a discrepancy Comments Text box Location for a user-supplied comment (optional). Status Action Resolution Comment Information field Drop-down list box Information System-generated status of the discrepancy (non-editable). Provides a list of sponsor-defined actions that you can select if you want to take action on the discrepancy. The user-supplied comment that accompanied a resolution action (noneditable). The components that are present in the tabs are listed and described above. Note that certain components that are read-only in the tabs for system generated discrepancies are editable and required for creating manual discrepancies. Specifically, the Reason and the Error Message Version 1.1 Page 7 of 20

Add Discrepancy tab and Add Section Discrepancy tab Oracle Clinical Existing discrepancy tab The details of each discrepancy associated with the current CRF component are presented in an individual tab. Each tab is color-coded to display the status of the discrepancy. You can use these tabs, subject to your privileges and the status of the CRF and discrepancy, to: review its current state review the change history review the resolution reason update the Error message or optional comment take action on the discrepancy. The number and type of existing discrepancy tabs depends on the CRF component: For a response field, there can be the following number of tabs: o any number of data-generated discrepancies o one open user-generated discrepancy o any number of closed user-generated discrepancy For a CRF section, there can be any number of open or closed user-generated discrepancies. Version 1.1 Page 8 of 20

Components in an Existing Discrepancy tabs Reason Name Type Description Error Message Comments Information field (read-only) Information field (read-only) Text box (editable) Display the reason the discrepancy was initiated. This is either supplied by the system, in the case of a data discrepancy, or by the user, in the case of a user-generated discrepancy. Displays the explanation that accompanies the discrepancy. This is either supplied by the system, in the case of a data discrepancy, or by the user, in the case of a user-generated discrepancy. Displays the current comment. This field is optional and so it may be blank. Status Information field System-generated status of the discrepancy (non-editable). Action Resolution Comment Drop-down list box Information (read-only) Provides a list of sponsor-defined actions that you can select if you want to take action on the discrepancy. The user-supplied comment that accompanied a resolution action. Information is displayed only if the discrepancy has been resolved. Version 1.1 Page 9 of 20

Existing Discrepancy tab Click on the Show Discrepancy History button to view the Change History from the Comments field (See below). Version 1.1 Page 10 of 20

Step by Step Instructions for Discrepancy Resolution in PDF 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 Step 1 Procedure To open the ecrf with active discrepancies, click on the red ecrf icon in the Main Screen. Step 2 Click on the Discrepancy Management tool or use the right click on your mouse feature to access the discrepancy management window. Discrepancy Management tool Right Mouse Click Version 1.1 Page 11 of 20

Step Step 3 Procedure Review the discrepancy (the example below is a system generated discrepancy) to determine if the discrepancy can be closed or does it need to be routed back to the site for further resolution. In this example, the site has indicated that the patient race is not known but it has been determined that the race is required by the protocol. This discrepancy will need to be routed back to the site for clarification.. Step 4 Highlight (delete) the comments that the site has entered. The comment will be viewable if you click on the >>Show Discrepancy History button. Version 1.1 Page 12 of 20

Step Step 5 Procedure In the Comments field, enter the clarification that will be needed for this discrepancy. Step 6 In the Discrepancy Action section, click on the drop down list for Action: Select Send to Investigator Step 7 To route to the site, Click the OK button. Version 1.1 Page 13 of 20

Step Step 8 Procedure Click the Save button to save the changes to the database. Once it has saved, the fields will turn yellow (indicating that it is actionable by another user group) and the ecrf icon in the main screen is also yellow (if there are no other discrepancies that you need to address on this ecrf). Discrepancies that require another user group s attention. Closing a discrepancy: Step Step 1 Open the ecrf Procedure Version 1.1 Page 14 of 20

Step Step 2 Procedure Open the Discrepancy management tool, review the Error Message and determine if this is a discrepancy that you can close (not created by another user group). 1. Review the site s response in the Comments section. 2. Ensure that the site has made the correction on the ecrf as noted in the Error Message. # 2. Site Correction # 1. Site Response Step 3 Click on the Action drop down list, select Close-resolved to close the discrepancy. Version 1.1 Page 15 of 20

Step Step 4 Procedure The Discrepancy Resolution Reason window will appear. In this example, the data has been changed by the site therefore you would select Data value changed. Disc no longer applicable. Step 5 A comment can be added if appropriate as noted in this example. Click OK Click OK to close the Discrepancy Management window Step 6 Click Save to save the changes to the database Field is highlighted in Green indicating that the discrepancy has been closed. Version 1.1 Page 16 of 20

Generating a manual discrepancy: Assume 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 Step 1 Procedure Click in the Physical Assessment data field. Right click to open your discrepancy management window or you can also click on the Discrepancy Management tool and click in the Physical Assessment data field for Skin. Step 2 In the Reason: drop down list, select Data Entry Comment Version 1.1 Page 17 of 20

Step Step 3 Procedure In the Error Message field, type the clarification that will need to be 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 Step 4 In the Action: drop down list select Send To Investigator to route to the site Step 5 Click OK to close the Discrepancy Management window Version 1.1 Page 18 of 20

Step Step 6 Procedure Click Save to save the changes to the database The data fields are now highlighted in Yellow indicating there is an outstanding discrepancy that will need to be addressed by the site. Reminder: Discrepancies that have been generated by another user group should not be closed unless indicated by your project specific guidelines for discrepancy management. Discrepancy created by Data Management Version 1.1 Page 19 of 20

Process Flows 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 20 of 20