Site Coordinator User Guide

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Lorraine Riley
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1 Site Coordinator User Guide for Oracle Clinical RDC (Remote Data Capture) Onsite Data Entry and Discrepancy Management Purpose: The purpose of this user guide is to document the Oracle Clinical RDC (RDC) Onsite Data Entry and discrepancy management functionality as it pertains to the site coordinator. Site Coordinator User Guide - Oracle Clinical RDC Discrepancy Mgmt.doc June 2016 Page 1 of 10

Data Entry I. Locate Patient 1 Log into Oracle RDC application (https://oraclerdc.zimmer.

corner, if multiple studies or sites are available to you 3 Select a patient or group of

rows (use shift-click or ctrl-click to select multiple patients) 4 Use dropdown arrow to

2 Data Entry I. Locate Patient 1 Log into Oracle RDC application ( ) by supplying correct user name and password 2 Select Study and Site from upper left corner, if multiple studies or sites are available to you 3 Select a patient or group of patients from the patient list on main panel of the home screen by clicking on the patient rows (use shift-click or ctrl-click to select multiple patients) 4 Use dropdown arrow to choose Multi- Patient View * *Multi-Patient View may be used even if only one patient is selected. Page 2 of 10

II. Patient Casebooks 1 If needed, select visit from Visit drop down box to locate the correct exam period 2 Click on the icon below the Form name that you plan to work on.

3 II. Patient Casebooks 1 If needed, select visit from Visit drop down box to locate the correct exam period 2 Click on the icon below the Form name that you plan to work on. 3 Data Entry screen with corresponding CRF will open in a new window III. Enter data 1 For each question, enter the correct value 2 Click on save icon on the top to save the form. 3 Save complete alert box will appear 4 If you have entered all the data needed (or available), click on Save Complete button. This option is recommended. 5 If you need more information (for example, need a lab result to be back) and do not wish to deal with discrepancies at this time, click on Save Incomplete button. 6 Once you click on Save Complete button, the form will go through discrepancy checks. List of discrepancies will be shown on the discrepancy panel (right side of the data entry screen). If the panel does not appear, click on the Page 3 of 10

Add Visit Page (to add more CRFs) For CRF that accepts multiple occurrences such as AE, use Add Visit Page to create a new occurrence: 1 Navigate to Casebooks

4 expanding key located on middle-right border of the data entry screen. 7 You can deal with the discrepancies right away or later. IV. Repeat step II and III as needed V. Add Visit Page (to add more CRFs) For CRF that accepts multiple occurrences such as AE, use Add Visit Page to create a new occurrence: 1 Navigate to Casebooks screen under the appropriate Visit. There will be an Add Visit Page button. 2 Highlight the line for the patient(in multi-patient view) or visit (in single patient view) where you want to add the CRF 3 Click on Add Visit Page button 4 Click on Continue button when the following screen comes up Page 4 of 10

5 Click on Continue button again when the following screen comes up The new data entry form is now

Validate Patient At times it is necessary to ask the system to calculate data points such as

5 5 Click on Continue button again when the following screen comes up The new data entry form is now added: VI. Validate Patient At times it is necessary to ask the system to calculate data points such as patient eligibility (for example after Inc/Exclusion was entered) or run certain discrepancy checks. To do so, follow the below steps to validate patient: 1 In Casebooks screen, select the patient you want to validate, then choose Validate from the dropdown 2 Click on Continue button when the following screen comes up 3 Click on Ok button when the following screen comes up Page 5 of 10

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7 Discrepancy management VII. Locate Discrepancies Users have various pathways available within RDC to view/review discrepancies, such as 1 Open a list available in the Activities section (e.g., Review Active Discrepancies ) 2 Select a patient or group of patients from the patient list on the home screen and use the review discrepancies option from the dropdown list 3 Execute a search for discrepancies from the Home, Patient Casebooks or Review tab VIII. Review & Manage Discrepancies After discrepancies are located within the system, follow the steps below to review/manage: Step 1 Open the CRF data entry window by clicking on the CRF icon* associated with the discrepancy 2 From the CRF data entry window, a list of discrepancies will be shown on the discrepancy panel (right side of the data entry screen). If the panel does not appear initially, click on the expanding key located on middle-right border of the data entry screen. 3 Review the discrepancy details shown in the list 4 Select an ** from the dropdown as appropriate to send the discrepancy to another person, or Update the data by clicking directly on the field in the form. If the data update does not resolve the discrepancy, select an from the dropdown as appropriate to send the discrepancy to another person. 5 Add comments 6 Save your changes Page 7 of 10

8 IX. Create new (manual) Discrepancies Follow the steps below to create a new discrepancy: 1 Open the CRF data entry window for the patient record 2 Click on the field in question 3 Click the add discrepancy icon at the top left portion of the screen, or right-click on the field and choose add discrepancy 4 Enter the appropriate information into the pop-up box ( field discrepancy applies to just one question/response, while section discrepancy applies to the entire CRF) 5 Save your changes X. Update CRF Data Follow the steps below to update CRF data: 1 Open the CRF data entry window for the patient record 2 Click on the field desired 3 Click the dropdown arrow in the top right corner of the field if one exists and choose the appropriate value. If no dropdown choices exist, simply enter the correct value or check/uncheck the box, as appropriate. 4 Add a reason for the update when prompted 5 Save your changes Page 8 of 10

9 Zimmer Biomet Technical Support Contact Information is below for Zimmer Biomet Data Management staff members: Sonya Baker-Yoder May Luo Page 9 of 10

10 Quick Reference *CRF Icons: indicates the CRF is not yet entered into the Oracle RDC system indicates CRF data is entered into the Oracle RDC system indicates CRF data is partially entered indicates the CRF is source document verified indicates the CRF is approved by the investigator ** descriptions are as follows: Send to Data Mgt sends the discrepancy to Data Management for review/action Send to CRA sends the discrepancy to the CRA for review/action Send to Investigator sends the discrepancy to the Investigator for review/action Patient/CRF Icon Colors: Red patient icon ( ) or CRF icon ( ) indicates an Active discrepancy assigned to you Yellow patient icon ( ) or CRF icon ( ) indicates an Open discrepancy assigned to a different user White patient icon ( ) or CRF icon ( ) indicates no outstanding discrepancies Page 10 of 10

Frequently Asked Questions

Frequently Asked Questions ACCESS AND NAVIGATION 1. Can I change my password? 2. What are the guidelines for a new password? 3. What types of information will I get in RDC news? 4. I closed RDC Onsite