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09-Apr-2019 OC/RDC Troubleshooting Guide for Site Users Page 1 of 17 OC/RDC Troubleshooting Guide for Site Users Contents SITE USER’S OC/RDC LOGIN PAGE ................................................................................................................... 2 SUPPORTED COMPUTER OPERATING SYSTEMS............................................................................................. 2 SUPPORTED INTERNET BROWSERS – INTERNET EXPLORER & SAFARI ........................................................ 3 INTERNET EXPLORER GENERAL SETTINGS ..................................................................................................... 3 Compatibility Check ............................................................................................................................... 3 Emulation Settings.................................................................................................................................. 4 Deleting Temporary Files ....................................................................................................................... 4 Verify disk space...................................................................................................................................... 5 Security Settings – Trusted Sites .......................................................................................................... 6 Pop-Up Blocker - Turn off ...................................................................................................................... 7 Enterprise Mode - Turn off ..................................................................................................................... 8 SAFARI 10 GENERAL SETTINGS......................................................................................................................... 8 FORGOTTEN PASSWORD OR ACCOUNT LOCKED .......................................................................................... 9 REQUESTING A TEMPORARY PASSWORD ....................................................................................................... 9 CHANGING YOUR TEMPORARY PASSWORD ................................................................................................. 11 OPENING A NEW SESSION IN INTERNET EXPLORER ..................................................................................... 14 OPENING A NEW SESSION ON A MAC ............................................................................................................. 15 OPENING A NEW SESSION ON IPAD................................................................................................................ 15 OPENING A NEW SESSION ON IPHONE .......................................................................................................... 16 HOW TO CLOSE CRFS....................................................................................................................................... 16 HOW TO SIGN OUT OF RDC (EDC.MEDTRONIC.COM) .................................................................................. 16 PAGE EXPIRED MESSAGE ................................................................................................................................. 17 BLANK CRF PAGE .............................................................................................................................................. 17 ADDITIONAL HELP............................................................................................................................................ 17

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Page 1: OC/RDC Troubleshooting Guide for Site Users...09-Apr-2019 OC/RDC Troubleshooting Guide for Site Users Page 2 of 17. Site User’s OC/RDC Login Page This is the web page all site users

09-Apr-2019 OC/RDC Troubleshooting Guide for Site Users Page 1 of 17

OC/RDC Troubleshooting Guide for Site Users

Contents SITE USER’S OC/RDC LOGIN PAGE ................................................................................................................... 2

SUPPORTED COMPUTER OPERATING SYSTEMS ............................................................................................. 2

SUPPORTED INTERNET BROWSERS – INTERNET EXPLORER & SAFARI ........................................................ 3

INTERNET EXPLORER GENERAL SETTINGS ..................................................................................................... 3

Compatibility Check ............................................................................................................................... 3

Emulation Settings .................................................................................................................................. 4

Deleting Temporary Files ....................................................................................................................... 4

Verify disk space ...................................................................................................................................... 5

Security Settings – Trusted Sites .......................................................................................................... 6

Pop-Up Blocker - Turn off ...................................................................................................................... 7

Enterprise Mode - Turn off ..................................................................................................................... 8

SAFARI 10 GENERAL SETTINGS ......................................................................................................................... 8

FORGOTTEN PASSWORD OR ACCOUNT LOCKED .......................................................................................... 9

REQUESTING A TEMPORARY PASSWORD ....................................................................................................... 9

CHANGING YOUR TEMPORARY PASSWORD ................................................................................................. 11

OPENING A NEW SESSION IN INTERNET EXPLORER ..................................................................................... 14

OPENING A NEW SESSION ON A MAC ............................................................................................................. 15

OPENING A NEW SESSION ON IPAD ................................................................................................................ 15

OPENING A NEW SESSION ON IPHONE .......................................................................................................... 16

HOW TO CLOSE CRFS ....................................................................................................................................... 16

HOW TO SIGN OUT OF RDC (EDC.MEDTRONIC.COM) .................................................................................. 16

PAGE EXPIRED MESSAGE ................................................................................................................................. 17

BLANK CRF PAGE .............................................................................................................................................. 17

ADDITIONAL HELP ............................................................................................................................................ 17

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Site User’s OC/RDC Login Page https://edc.medtronic.com

This is the web page all site users such as Coordinators, Investigators, Core Lab personnel and external Monitors use to access Oracle Clinical/Remote Data Capture (OC/RDC).

Supported Computer Operating Systems Not all computers are supported by Oracle Clinical/Remote Data Capture (OC/RDC). Supported Browsers:

• Internet Explorer 11 o Microsoft Windows 10 o Microsoft Windows 8 o Microsoft Windows 7

• Safari 10 o OS X 10.11 o macOS 10.12

Mobile Operating Systems:

• Safari 10 - iOS 10.3 NOT Supported: Windows XP Android mobile devices

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Supported Internet Browsers – Internet Explorer & Safari Internet Explorer 11 and Safari can be used to access Oracle Clinical/Remote Data Capture (OC/RDC). We cannot provide support or troubleshooting activities for any other web browser. Site users must work with their site IT group to upgrade to IE 11. Supported versions:

Not supported: Other web browsers such as Chrome, Firefox, and Microsoft Edge (included with Windows 10) are not supported. They will not work with Oracle Clinical/Remote Data Capture, so be aware which browser you use when logging into OC/RDC.

Internet Explorer General Settings

Compatibility Check If your browser’s Document mode is not set to 11 or Edge, you will receive a Compatibility Check page. You will need to follow the steps below to correctly set IE 11’s Emulation Settings.

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Emulation Settings Important: The Document mode must be set to 11, the Browser profile must be set to Desktop, and User agent string must be set to Default. Admin privileges are required to change these settings. Contact your site IT for Admin privileges to change these settings. 1) Go to https://edc.medtronic.com press the F12 key on your keyboard 2) Select Emulation tab 3) Set Document mode to 11 4) Set Browser profile to Desktop 5) Set User agent string to Default 6) Press the F12 key on your keyboard to close the window

Deleting Temporary Files Internet Explorer downloads website data (temporary internet files) to be used in current and future connections to that website. This improves the efficiency of reconnecting to the same website by only downloading changed content. Sometimes, this cached data is incorrectly used by Internet Explorer, so deleting these temporary files is necessary. To delete temporary files 1) In Internet Explorer click on the Tools menu. 2) Select Internet options. 3) On the General tab click Delete.

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4) Uncheck the box to Preserve Favorites website data. 5) All the other items can be checked. 6) Click Delete. Note: This step should be performed if OC/RDC is returning errors. We recommend clearing the temporary internet files then close all Internet Explorer windows and try to access OC/RDC again.

Verify disk space 1) On the General tab click Settings. 2) Select the option Every time I visit the webpage. 3) Ensure the ‘Disk space to use’ is set to 1024 and click OK.

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Security Settings – Trusted Sites Add the OC/RDC link (https://edc.medtronic.com) in Trusted Sites.

1) In Internet Explorer click on the Tools menu. 2) Select Internet Options. 3) Click on the Security tab. 4) Click the Trusted Sites icon. 5) Click on Sites.

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6) Enter https://edc.medtronic.com 7) Click Add and then Close.

Pop-Up Blocker - Turn off The Pop-up Blocker should be turned off.

1) In Internet Explorer click on the Tools menu. 2) Point to Pop-up Blocker and ensure that the Pop-up Blocker is turned off.

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Enterprise Mode - Turn off Enterprise Mode should be off.

1) In Internet Explorer click on the Tools menu. 2) Look at Enterprise Mode and ensure it is not checked.

Note: Typically, Enterprise Mode is off. A checkmark will be present if it is on.

Enterprise Mode ‘Off’ Enterprise Mode ‘On’

Safari 10 General Settings Safari Mobile The mobile browser version is the same as the iOS software version. 1) Go to Settings > General > About > Software Version 2) Go to Settings > Safari > Block Pop-ups and turn off the pop ups 3) Go to Settings > Safari > Clear History and Website Data 4) Go to Home > Open Safari browser and enter website https://edc.medtronic.com and log in Mac Operating System (macOS) From the Apple menu in the corner of your screen, choose About This Mac. You will see the macOS name followed by its version number. 1) Open Safari browser. From the top left corner click on Safari > Preferences 2) Click Security & Privacy 3) Place a check in the box beside Allow Java 4) Place a check in the box beside Allow all other plug-ins 5) Turn off the Pop-up blockers 6) Go to Privacy. Look for the Cookies and website data heading and select Always allow 7) Look for the Accept cookies heading and select Always

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Forgotten Password or Account Locked If a user has forgotten their password or their password expired (locked account) they will need to request a temporary password and then change their temporary password. An account will unlock when the password is changed.

Requesting a Temporary Password Follow the steps below to request a temporary password. 1) On the login page (https://edc.medtronic.com/) click on Forgot Password.

2) Enter your user email address or Medtronic User Name then click NEXT.

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3) You will see a message that a new, temporary password has been sent to your e-mail address. The email is sent to the email address that is entered in the system.

4) The user should look in their email inbox for the email. This is a sample of the email with a temporary password:

If the email is not received: • The email is sent to the email address entered in the system. If the user has a new email

address they should contact their Medtronic study team. The study team can update the email in the OLS system. Another way is to contact the Medtronic RDC Help Desk. The Help Desk cannot update the email address but will submit a support ticket.

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• The email may have been identified as ‘spam’ or ‘junk’ by the user’s email system. To correct this and ensure the email arrives, the site user should attempt to add [email protected] as a trusted sender or add as a contact.

5) After receiving the email, click the Return to login screen link to take you to the login page.

6) On the login page https://edc.medtronic.com/ enter your UserID and the temporary password received in the email and click Login.

Changing your Temporary Password For security reasons, you will be asked to change your temporary password when you log in for the first time. A more secure password is one that is not easy to guess. Please follow the password requirements noted in your email with your temporary password.

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7) Enter the temporary password in the Old Password box and enter your new password in the New Password and Confirm New Password boxes. Click Change Password.

Confirm you receive a pop-up window displaying your new password has been set. Click on CONTINUE.

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8) You will be taken to the login page https://edc.medtronic.com/

Enter your UserID and your new password and click Login.

9) If you have access to only one study, RDC will open automatically. If you have access to more than one study, you will be brought to your “Select a Study” page. You must select a study to proceed into RDC. If you decide to close your session you may click on Logout.

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Opening a New Session in Internet Explorer If you receive a message “Multiple tabs are not supported for this application. Please close all browser windows and open a new browser session”, close all browser windows and then open a new session.

Click on File then select New Session.

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Opening a New Session on a Mac Go to File > New Private Window from the menu bar (Another way to do this is to click Shift-Command-N using your keyboard shortcuts).

Opening a New Session on iPad Tap [& hold] the Tab icon in the upper right-hand corner for options to display. Select New Private Tab to open a new RDC session.

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Opening a New Session on iPhone Tap [& hold] the Tab icon in the lower right -hand corner for options to display. Select New Private Tab to open a new RDC session.

How to Close CRFs All users should always close an open CRF using the correct method described below. If CRFs are not closed properly, the next time you open a CRF, you may encounter a CRF opening in browse mode. Correct Method Incorrect Method Click the red X in the CRF Do not click the Internet Explorer browser window X.

How to Sign Out of RDC (edc.medtronic.com) To minimize errors, please follow the below steps to sign out of RDC. 1) Click on the Logout link.

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2) Close the entire Internet Explorer window. This will minimize the impact of getting a “Page Expired” message.

Page Expired Message If you do not log out of RDC properly you may receive a “Page expired” pop-up or “Session is inactive, please log in again” message.

Blank CRF Page There can be some issues if attempting to open a CRF using the Review tab. A common error is where the CRF doesn’t open or only opens as a blank page. This does not occur all the time, but if it does, the workaround is to locate and open the CRFs using the Home tab.

Additional Help If further assistance is needed, please contact the RDC Help Desk. Go to https://edc.medtronic.com, click on Contact RDC Help Desk and open the Medtronic Site User RDC Help Desk phone numbers.