RDC Handbook

Document Version: 1.2

Version Date: 12/04/2011

SIRO CLINPHARM PVT LTD DIL Premises, 2nd Floor; Swami Vivekanand Road

Ghodbunder Road; Thane (W) 400 607 INDIA

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Review and Approval Page

Prepared by:

Deepawali Bhalekar Project Secretary –Information Technology

Date 10 March 2011

Reviewed by: Nimesh Thakkar Executive – Information Technology Date 25

March 2011

Approved by:

Shyamanta Phukon Manager – Information Technology Date

Revision History

Version Date Author(s) Change Details

1.0

25/03/2011 Deepawali

Bhalekar Add RDC FAQ’s and change the Document Name.

1.1 5/04/2011 Deepawali Bhalekar

Add the following two point 1. Tracert the IP 2. Check computer information

1.2 12/04/2011 Deepawali Bhalekar

Change on this document is add section number 8(Bandwidth to the Internet)

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TABLE OF CONTENTS

RDC HANDBOOK .................................................................................................................. 1

REVIEW AND APPROVAL PAGE ......................................................................................... 2

REVISION HISTORY .............................................................................................................. 2

TABLE OF CONTENTS ......................................................................................................... 3

INTRODUCTION .................................................................................................................... 4

1. RDC LINKS:- ................................................................................................................... 4

2. APPLICABLE RDC RESPONSE TIME :- ........................................................................ 4

3. REQUIREMENT FOR RUNNING THE RDC ONSITE APPLICATION ............................ 4

4. CHECKING THE INTERNET EXPLORER SETTING ...................................................... 4

5. CONFIGURING THE CACHE SETTINGS FOR THE INTERNET EXPLORER ............... 6

6. TRACERT THE IP ............................................................................................................ 7

7. CHECK COMPUTER INFORMATION ............................................................................. 7

8. BANDWIDTH TO THE INTERNET .................................................................................. 9

9. RDC FAQS ...................................................................................................................... 9

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Introduction This guide describes how to configure setting of Internet Explorer for Oracle Clinical Remote Data Capture Onsite (RDC Onsite) application. Users do not need to install any additional software onto their computers because RDC Onsite is a Web application. Users use web browser to access the RDC Onsite application over the internet.

1. RDC Links:-

Following are the RDC links:

RDC Link (Live): https://cdm-pr-rdta-2.siroclinpharm.com/

RDC Link (Test): https://cdm-pr-rdta-

2.siroclinpharm.com/olsa/oc/rdcLogin.do?event=doSetup&mode=T

2. Applicable RDC Response Time :-

Step Response time in Seconds

1 Opening page 10-12

2 Login 10

3 Opening CRF 45

4 Saving data after entry 15

5 Hit Next page 10

6 Logout 8

3. Requirement for Running the RDC Onsite Application

The Requirements to run the RDC Onsite application are as follow:

A Computer with high-speed internet connection.

Microsoft Internet Explorer, Version 6.0 or later.

Oracle supports Internet Explorer 6.0, but recommends Internet Explorer

7.0. Microsoft made significant performance improvements in internet explorer 7.0. Data entry

operation, such as opening and saving a CRF, are faster on Internet Explorer 7.0 than on Internet

Explorer 6?

The Web address for the RDC Onsite application.

A unique user name and password for login.

4. Checking the Internet Explorer Setting

Prior to running RDC Onsite for the first time,

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Verify that version of Internet Explorer meet the minimum requirement.

Check that the Internet Explorer connection, security, and privacy setting are configured

properly.

Although RDC Onsite is compatible with the default Internet Explorer setting for your computer

may have been modified. If user ever have difficulty starting up the RDC Onsite application,

always check the Internet Explorer setting.

To Check the Internet Explorer Setting

Open Internet Explorer.

Open the Help menu and select “About Internet Explorer” to view the version number. RDC

Onsite requires Version 6.0 or later of Internet Explorer.

Open the Tools menu and select Internet Options.

Click the Advanced tab.

Scroll down to the HTTP 1.1 settings. Make the following changes: o Select the Use HTTP 1.1 check box. o Select the Use HTTP 1.1 through proxy connections check box.

Scroll down to the Security setting. Make sure that “Do not save encrypted page to disk”

setting is not selected:

Click the Security tab. Make the following changes: o Select the “Trusted Sites” button and click “Sites” button o Enter the address: https://cdm-pr-rdta-2.siroclinpharm.com and click Add button

o Click OK to close the dialog box o Click the Custom Level button to open the Security Settings window. o Scroll down to ActiveX controls and plug-ins. Under “Run ActiveX controls and

plug-ins”, click Enable.

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o Scroll down to Scripting. Under Active scripting, click Enable.

o Scroll down to Miscellaneous. Under “Use Pop-up Blocker”, click Disable.

o Click OK to save your changes and close the window.

Click OK to save all your changes and close the Internet Options window.

5. Configuring the cache settings for the Internet Explorer

The Performance of the RDC Onsite application improves by properly configuring the amount of disk space that the Internet Explorer uses to cache temporary Internet file. This caching space increases the speed at which RDC Onsite displays pages and CRFs.

The recommended size for the cache depends on the design of the CRFs (Case Report Form) in user study, user usage patterns, and the number of other web sites and application that you frequently access.

To set the cache settings for the internet explorer:

Open Internet Explorer

Open the Tools menu and select Internet Options.

Click the General tab. In the Temporary Internet Files section, click the Settings button to

open the Settings dialog box.

o Select automatically for the Check for newer versions of stored pages setting. o Set the amount of disk space to use for the Temporary Internet Files folder. o Click OK to save your changes and close the dialog box.

Click the Advanced tab.

o Scroll to the Security section. o Make sure the “Empty Temporary Internet Files folder when browser is closed’

check box is not selected:

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Click OK to save all your changes and close the Internet Options window.

6. Tracert the IP

Follow the below steps for check IP 123.108.47.114 443 or 80 if a blank window appears

that means these ports are opened in your firewall

Open the RDC link in your internet explorer, and see if the page is getting opened

properly this is to check if the link is not blocked using your network proxy software or not.

Click on Start

Click on Run

Type cmd then type IP 123.108.47.114 80 or 443

Please find the below output of the process

7. Check computer information

Below step is use for find correct computer information. You will get the computer name,

OS version, hardware information etc.

Click on Start

Click on Run

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Type cmd then type Set and enter

Please find the below output of the process

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8. Bandwidth to the Internet Follow the below step for check internet speed on your system.

Open the internet Explorer.

Use below link

http://www.speedtest.net Click on Begin Test

You will get output as per below print screen.

9. RDC FAQs

Login Problems:-

1. I am receiving error “ORA-01017: invalid username/password; access denied” and I know my username and password are correct.

Comment: After trying to log in three times with an invalid password your account is automatically locked. After this point you will receive the same error even if you enter your correct user credentials.

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Solution: Call the EDC Support Center to unlock your account. Please remember you will have to reference your PIN number if you need your password reset.

2. How to change my password?

Solution: After login RDC Onsite, click on the link Change Password.

Enter your old password and new password; click Apply to save the new password.

For further assistance please call the EDC Support.

3. When I log in to RDC I receive the error “No Access to any RDC accessible Studies. Contact your system administrator. Exiting Form.”

Comment: This error indicates you have not yet received production access to the study you are trying to log into. Solution: Please contact your Clinical contact for assistance with gaining production access to the study in question.

Problems seeing study or patient numbers once I log in:

4. When I log in I do not see the study I am currently working on. Instead, I see an old study I

worked on a while back.

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Comment: You probably have access to several studies on that particular RDC server. You continue to have Browse access to the old study and may have Production access to the new study.

Solution: In order to access the new study, go to the Study Site on the top right corner. Click on the drop down list to select the new study in question and the site next to it.

If no other studies show up please contact your Clinical contact for assistance with gaining production access to the study in question.

5. I have logged in and found my site but cannot locate my patient number. It does not appear to

be listed.

Comment: Please check whether the patients are enrolled for this site by clicking on Study and Site summary link.

Solution: If you have already enrolled patients and the number still does not appear in RDC please contact the EDC Support Center for assistance.

Problems Opening, viewing or navigating to CRF:

6. I am trying to review a patient and get "No patient has been selected for this action. Please

select a patient." Comment: A patient needs to be "selected" from the list by clicking on the checkbox next to the patient number prior to choosing an action.

Solution: Please check the box next to the patient number and then try the action again.

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7. When I click on a CRF nothing happens.

Comment: If you do not see a CRF window come up, you probably have an active pop-up blocker that has prevented the CRF window from being displayed.

Solution: Please configure your pop-up blocker to allow pop-ups from RDC servers or contact the EDC Support Center for assistance.

8. I am having difficulties viewing CRFs - the page opens, however the borders around certain

fields appears to be shifted or not displayed at all. Comment: There are two known causes of this issue. This problem may be present if you are using an unsupported browser to run RDC. Examples of unsupported browsers are Mozilla Firefox or Google Chrome.

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Solution: Please make sure you are only using Microsoft Internet Explorer 6 or above to run RDC.You will also see the problem when using Internet Explorer version 8. To resolve this, you must run RDC in what is called compatibility mode.

Click on Tools Menu (or from Command bar), click "Compatibility View Settings"

Ensure the RDC URL is displayed in the field before the Add button. Click the Add button

Confirm that siroclinpharm.com is now added to list "websites in Compatibility View:"

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Click "Close" button to confirm the settings

9. When I open a CRF I receive the error “This CRF was created using classic Data Entry mode. It must be migrated, for display in PDF mode.”

Comment: This CRF was created using classic Data Entry mode. It must be migrated, for display in PDF mode.

Solution: Please contact your Clinical contact for assistance in routing this issue to the concerned group.

10. I do not see all the patients enrolled in a particular study.

Comment: This happens when you have restricted the patient’s numbers display.

Solution: Please click on the link preferences to customize the display as per your preferred requirements.

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Problems approving CRFs:

11. When I try to approve my patients the option is not available.

Comment: When you open the CRF to approve, approve icon is not available. Only approval history icon is available. This usually happens if you have not received approval rights.

Solution: Please check with the EDC Support Center regarding approval rights.

If the CRF is in unlocked state and you have approval rights, still options is grayed out then please contact your EDC Support center.

Problems in saving the form

12. When I enter data and save the form, the changes are not saved.

Comment: When entering data for a form, please be sure to tab through each field.

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Solution: When saving a form, please be sure that you are tabbed out of every field before saving the form.

If you do use the mouse to try to save and your cursor is still in one of the fields then you will likely receive an error.

Problems with Reports

13. When I try to open the reports, reports open blank.

Comment: This usually happens when a PDF screen is already open or likely a problem with Adobe Reader. Solution: Please see if any .PDF files open on your machine.

Please make sure you are using Adobe 7 or 8. If you already have version 7 or 8, try rebooting your computer.

Please Call the EDC Support for assistance.