Discrepancy Management While working in OC RDC, you will encounter discrepancies with various assigned statuses. The description of each type of status is listed below. Unreviewed 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. 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. 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 Pharmacovigilance/Safety (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. 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. Page 1 of 14
Viewing Active Discrepancies Oracle Clinical Active discrepancies are RED discrepancies requiring action by user group logged in 1. Click on the Review Active Discrepancies Hyperlink 2. This takes you to the Discrepancies section of the Review tab (see below) The discrepancies are listed here and from this page you can: View the Details by clicking the blue icon Open the CRF by clicking the Open CRF icon NOTE: You can also directly navigate to the Review Discrepancies tab at any time to view all discrepancies Page 2 of 14
CRF Navigator The CRF Navigator is a window pane that can be displayed on the right side of an ecrf. It contains two tabs, one of which is the Discrepancy Tab. The discrepancy tab lists any discrepancies on the open page allowing the site user the option of resolving/closing or routing the discrepancy. When you highlight a discrepancy in the Discrepancy list, you will see the details of the discrepancy in the lower section of the pane. Page 3 of 14
by Instructions for Discrepancy Resolution 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: 1 To open the ecrf with active discrepancies, click on the red ecrf icon in the Patient Casebook Spreadsheet. 2 Once the page is open, open the CRF Navigator pane on the right hand side of the ecrf page. To see the details associated with a particular discrepancy, select the discrepancy from the pane and view text in the details box below. Please ensure that All Discrepancies is selected in the Highlight box. Select Discrepancy here Details display below Page 4 of 14
3 Review the discrepancy to determine if the discrepancy can be closed or if it needs to be routed back to the site for further resolution. In this example, the site has indicated that the patient s systolic blood pressure is in fact correct. This is outside of the acceptable systolic blood pressure range for this study. We will therefore route it back to the site to inform them of this. 4 Select Send to Investigator from the Action drop-down box at the bottom of the CRF Navigator pane and click Go. Page 5 of 14
5 The Discrepancy Action Send to Investigator box appears. Highlight the original comment currently in the Comment (optional) field and type your response to the discrepancy in that field and then click OK. Type discrepancy response here Remember to SAVE your changes to the ecrf. NOTE: The original comment text remains as part of the discrepancy history and is viewable by selecting the History button in the CRF Navigator pane. 6 The discrepancy now appears with a yellow highlight, indicating it is now actionable by the site user. To view the Discrepancy history which includes the original comment from the site user, click the History button with the CRF Navigator pane. Page 6 of 14
Closing a discrepancy: 1 Open the ecrf page and highlight the relevant discrepancy from the List in the CRF Navigator pane. Remember that discrepancies requiring your attention will show to you as red. Always read the Details associated with the discrepancy prior to selecting an option from the Action drop-down list. Page 7 of 14
2 Determine if this is a discrepancy that you can close (not created by another user group). 1. Review the site s response in the Comment section. 2. Ensure that the site has made any relevant corrections to the ecrf (where applicable). NOTE: Use the Audit History pane to view details of any changes made to data. 3 Click on the Action drop down list, select Close-resolved to close the discrepancy. Click Go. Page 8 of 14
4 The Discrepancy Action Close resolved window will appear. In this example, the data has not been changed by the site therefore you would select : No action required within the Resolution Reason drop-down list. There are 2 options within this window. If the site changed a data point in response to a query and you were closing it after final review, then you would select the option, Data value changed. Reminder: Discrepancies that have been generated by another user group should not be closed unless indicated by your project specific guidelines for discrepancy management. Page 9 of 14
5 It is best to include a Resolution Comment in that section so it is clear why the Discrepancy was closed. Click OK to close the Discrepancy Action window 6 Click the Save icon. This discrepancy now displays in green to indicate a closed/resolved discrepancy. Page 10 of 14
Generating a manual discrepancy: Assume that during SDV, you notice that the time of Vital Signs does not match the source documents. A discrepancy will need to be created to ask the site to check this inconsistency. 1 Click on the data field that you wish to raise a discrepancy on. This field will now have a grey box surrounding it. 2 Click on the Add Discrepancy button on the toolbar. Page 11 of 14
3 The Add Discrepancy dialog window displays, allowing you to choose either the Field Discrepancy, or, if applicable, the Section Discrepancy radio button. NOTE: Discrepancies can be added to fields or sections of the ecrf. The Reason box should always have Data Entry Comment selected. 4 The discrepancy text should be typed in the Description field. NOTE: Do not type anything in the Comment (optional) field. This is to be used by site when they communicate back to you via the discrepancy window. Page 12 of 14
5 Select Send to Investigator in the Action box and then click OK. This routes the discrepancy for the attention of all site staff. 6 The field is now highlighted in yellow and the discrepancy appears in the list on the right side of the screen. Click the Save icon. Page 13 of 14
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. Page 14 of 14