5_Training Manual.pdf

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Comparison of Age-Related Macular DegenerationTreatment Trials (CATT)

Oracle Clinical Remote Data Capture Users Manual

Version 1.01_20080904

Prepared by:Clinical Research Computing Unit (CRCU)

Center for Clinical Epidemiology and Biostatics (CCEB)University of Pennsylvania School of Medicine

3535 Market Street, Suite 560

Philadelphia, PA 19104-3309

THESE DOCUMENTS ARE THE PROPERTY OF THE CLINICAL RESEARCH COMPUTING UNIT (CRCU), A DIVISION OF

THE UNIVERSITY OF PENNSYLVANIAS SCHOOL OF MEDICINE AND THE CENTER FOR CLINICAL EPIDEMIOLOGYAND BIOSTATISTICS (CCEB). THESE DOCUMENTS CONTAIN PRIVILEGED, PROPRIETARY, OR OTHERWISE PRIVATE

STUDY INFORMATION AND SHALL NOT BE REPRODUCED, DISTRIBUTED, DISCLOSED OR USED WITHOUT THE

EXPRESS WRITTEN CONSCENT OF THE CLINICAL DATA MANAGEMENT DIVISION OF THE CLINICAL RESEARCH

COMPUTING UNIT (CRCU).


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Table of Contents

I Installation and Getting Started page 1

1.1 RDC Software Installation page 21.2 Connecting to the Oracle Clinical RDC Application page 71.3 Medication Reference Tool Downloads page 91.4 Troubleshooting RDC Installations page 11

II Logging-In page 15

III Navigation and General Overview page 18

3.1 News Items page 183.2 Activity List page 193.3 Command Buttons and Menus page 273.4 Main Spreadsheet page 38

IV Printing Case Report Forms (CRFs) page 47

4.1 Printing CRFs from CATT Landing Page page 484.2 Printing CRFs from an Open PDF page 55

V Accessing Study Tools Adverse Event Coding and ConcomitantMedication Coding page 56

5.1 Adverse Event Coding page 575.2 Additional Adverse Event Pages page 675.3 Concomitant Medication Coding page 705.4 Additional Concomitant Medication Pages page 78

VI General Data Entry Instructions page 81

6.1 Patient Registration page 836.2 Entering CRFs page 87

VII Discrepancy Management page 96

7.1 Accessing Discrepancies page 977.2 Correcting Errors page 1027.3 Creating Manual Discrepancies page 109

VIII Randomization, Patient Visit Calendar, and Patient RandomizationAssignments page 112

8.1 Patient Randomization page 1128.2 Patient Visit Calendar and Randomization Assignment page 114

VIII List of Abbreviations page 125

VIV Glossary page 126


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V1.01_20080904 Oracle Clinical Users Manual Page 1 of 137

Oracle Clinical Remote Data CaptureInstallation and Getting Started

Personal Computer (PC) Requirements

For Oracle Clinical Remote Data Capture (RDC) users:

Windows 2K (any release, although preferably Service Pack [SP] 4), XP Home orProfessional (SP2)

1.

An account that can install software (i.e., must be able to modify registry entries),preferably with administrative privileges.

Adobe Acrobat Reader (or Professional) 6, 7, or 8 installed (any subrelease).

o If Adobe is not installed, it can be downloaded from the Adobe website http://www.adobe.com. Follow the installation instructions provided by Adobe.

Internet Explorer (IE) 6 or above.

If the users internet browsers popup blocker is enabled, make sure to allow popups fromthe following websites: rt1.cceb.med.upenn.edu and rt4.cceb.med.upenn.edu.

If your browser has Yahoo Search, Google Toolbar, AOL Toolbar, Windows Messengeradd-ons, they should be disabled

2.

o To disable them in IE 6, the add-on needs to be removed using the ControlPanels Add or Remove Programs tool.

o To disable then for IE 7, go to the Tools menu and select Manage Add-ons; clickon the add-on and check Disable. Repeat for each add-on found. You need torestart IE for the changes to take effect.

Citrix: If Citrix is used at the users site, IT personnel should assist in the installation ofRDC software. The IT personnel will need to make sure that either:

o The users account has write access to its remote Document and Settings folderand Citrix servers registry, or

o The users account is setup so that RDC installation can be done locally on theusers Personal Computer (PC), on which the account has administrativeprivileges.

1Vista and Apple Macintosh OS are not supported at this time.

2There is a conflict between this tools Java Virtual Machine and one of the two installed for RDC.
http://www.adobe.com/http://www.adobe.com/


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1. RDC Software Installation

To install the software necessary to access Oracle Clinical Remote Data Capture (RDC)database, open your IE browser and go to the CATT Study Main Landing Page:http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html

To access RDC, click on the hyperlinks outlined above, (the direct link ishttp://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htm). This will bring the user to the RDC MainLanding Page.

http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.htmlhttp://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.htmlhttp://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htmhttp://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htmhttp://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html


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Click on the Downloads (http://rt1.cceb.med.upenn.edu/opa45/opa45_download.htm)link, outlined above. The following page will come up:

InstallingJinitiator

Under the heading Jinitiator, click on the Download link(http://rt1.cceb.med.upenn.edu/jinitiator/jinit.exe). The user will be prompted to save orrun the self-extracting jinit.exe file, which is necessary to access Oracle Clinical. Savethis file to the users PC and double-click on it (or simply click on the Run button ofInternet Explorers download window). Jinitiator installation will begin.
http://rt1.cceb.med.upenn.edu/opa45/opa45_download.htmhttp://rt1.cceb.med.upenn.edu/jinitiator/jinit.exehttp://rt1.cceb.med.upenn.edu/jinitiator/jinit.exehttp://rt1.cceb.med.upenn.edu/opa45/opa45_download.htm


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Click OK and, after unpacking the jinitiator software, the welcome screen will display:

Click Next and the installer will prompt you for a location:

The installers default location C:\Program Files\Oracle\Jinitiator 1.1.8.24.Click Browse if the user would like to change this location. Otherwise click Next andthe installer will perform the installation.

Installing OPA PDF Plugin

Before you download the OPA PDF plugin, make sure that

Adobe Acrobat 6.0, 7.0, or 8.0 Reader (or equivalent Professional) is installed on theusers PC.



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In Start/Programs/Jinitiator Control Panel 1.1.8.24/ Basic tab check that NetworkAccess is set to Unrestricted (default is AppletHost).

On the OPA Download page shown on page 3, under the Jinitiator section, the user willsee the heading RDC Plugin. Within this area, click the link Download - OPA RDCplug-in (US-English).

An alert will prompt you to download the opapdf.exe file. Click Save to save this to theusers PC, noting the location where it is saved.

After the download is complete, double-click the link to execute the installation, or findopapdf.exe and double-click on it.

This Installation Wizard will start and asks the user to accept the legal terms of usingcopyrighted software.

After click Yes, the download will proceed.



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Click Finish to exit.

At this point, the user has installed the software needed to run Oracle Clinical Remote DataCapture (RDC). The user will also need to install a plug-in to access the Medication Reference

Tool, follow the instructions on page 9 of this guide.



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2. Connecting to the Oracle Clinical RDC application

As previously discussed, the user may start from CATT Main Landing Page:http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.htmlor directly go to RDC Main page(http://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htm).

From the RDC Main page, click the Login button.

The following window will display on the users screen:

Do not close this window, as it is required during the users session while connected tothe database. This window may be minimized, but must remain open while using RDC.

The first time a user logs into Oracle Clinical RDC, the components will automatically downloadand update the RDC environment.

Once these downloads are complete, the objects will be cached in the users system, which willallow the user to log in faster in the future.

Finally, the user will be presented with the login screen to Oracle Clinical RDC.

Enter the username, password and database. If the log is successful, the Activity List will bedisplayed.

http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.htmlhttp://rt1.cceb.med.upenn.edu/opa45/rdclauncht.htmhttp://rt1.cceb.med.upenn.edu/opa45/rdclauncht.htmhttp://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html


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o Click on Run to start the installation. If the user does not need to install in a locationdifferent from the default (C:\Program Files\Oracle\Jinitiator 1.3.122) then the user canaccept all defaults and the software will be ready to use.

Once the Jinitiator 1.3.122 and the certificates are installed, the Medication Reference Tool canbe accessed at any time - instructions for accessing the Medication Reference Tool arediscussed on pages 70 80.



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4. Troubleshooting RDC Installations

This section contains some of the most common issues users have encountered whiledownloading or deploying RDC, and this section will provide some possible solutions orworkarounds.

The issues listed in this section are by no means exhaustive, given the large variability inOperating Systems (OS) levels, browser types and versions, and Adobe Acrobat Readerconfigurations. The FAQ section of the CATT Main Landing Page (see below) will be updated as

new issues come up.

In case none of solutions listed here or in the FAQ section solves the users problem, please donot hesitate to contact CRCUs Help Desk via email ([email protected]) or phone(1.215.573.4623).

I. Error extracting Jinitiator

Reason: Account has no administrative privilegesFix: Install as Administrator

II. Jinitiator installer hangs

Reason:

A mapped drive is unavailable

Fix:Go in Windows Explorer and look for any drive (physical or virtual) that cannot beopened. Disconnect it and retry

Reason:Issue with 16-bit subsystem

mailto:[email protected]:[email protected]


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Workaround:Try changing the tmp and temp environment variables in user profile to c:\temp. Theymight be set to %USERPROFILE%\Local Settings\Temp by default.The older 16-bit InstallShield can't handle long names. Retry.

III. Jinitiator installation does not complete.

Reason:In a few cases, if you do not have administrative privileges on the machine you areinstalling Jinitiator onto, the Jinitiator installer will fail to update the Windows registry.

Workaround:Find your username in the Users and Passwords of your PC. Select it and check itsProperties. The user should be in the Administrators or at least in the Power Users group.If it is not, your technical support should login as Administrator or give your user accountthe right privileges. After that, try running the installation again and it this time it shouldcomplete.

IV. Jinitiator installs, but nothing else happens.

Reason:Your security rules may not allow the browser to spawn the Jinitiator applet.

Workaround:For Internet Explorer, check the Internet Options. Make sure that security level is not setto High for the zone our web server is in. Also, check in Advanced that you can runActiveX controls and set the ActiveX options to at least Prompt level.

Should the above steps fail to solve your issue, make sure popup blocking is on for oursite: in IE 6.0, go to Tools/Popup blocker and make sure our site is allowed popups. In IE7.0, bottom left corner of the screen, click the document icon, and

V. Get error Your security settings do not allow Web sites to use ActiveX controlsinstalled on your computer. This page may not display correctly

These steps may resolve the issue:

1. Open Internet Explorer.2. Select Tools then Internet Options from the menu bar.3. Click on the Security tab.4. Select a network zone

3

5. Press the Custom Level button near the bottom of the screen.6. In the Security Settings screen that opens, under Reset custom settings at the

bottom on the screen, select Medium from the drop-down menu, and click the

Reset button.7. In the Settings list at the top of this screen, scroll down under the ActiveXcontrols and plug-ins option (this is the first option) until you see the option RunActiveX controls and plug-ins. Make sure that the radio button next to Enable isselected for this option.

8. Click OK to apply.9. Back in the Internet Options screen, click the OK button.

Close, relaunch the browser, and try again to connect to our URL.

3We suggest you change security levels for a network zone you can trust, like Trusted sites or Local Intranet. Never

change the defaults for the Internet zone, since those changes may decrease your Internet browsing security. Youshould therefore place our website in your Trusted sites or Intranet zones and customize the security settings there.


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VI. Blank Internet Explorer window when attempting to open the application URL

This is usually is a sign that the Jinitiator installer is unable to install the plug-in due to theInternet Options settings on your computer. Here are a set of steps that may solve yourproblem:

1. In Internet Explorer, go to Tools - Internet Options and select the Security tab.

Highlight the Web zone that matches the icon appearing at the bottom right of theBrowser window. Click on the Custom Level button.

2. Make sure that the following options are set to the Prompt or Enable level:a. Download signed ActiveX controls - Promptb. Run ActiveX controls and plug-ins - Enable (or Prompt)c. Script ActiveX controls marked as safe for scripting - Enable (or Prompt)

3. Go to Tools - Internet Options and select the 'Advanced' tab.

4. Make sure that Do not save encrypted pages to disk is NOT checked.

5. If none of the above solves your problem, please contact the CATT Help Desk.

VII. PDF does not open up

Reason:IE link to Acrobat broken

Fix:Reinstall Acrobat Reader and RDC plugin

Reason:Pop-up blocker has not been disabled

Fix:Enable pop-ups from rt1.cceb.med.upenn.edu, rt4.cceb.med.upenn.edu in InternetExplorers Tools/Pop-up Blocker/Pop-up Blocker Settings

Note: Some toolbars, like Google Toolbar, have built-in pop-up blocker functions. Also,some computer systems may have specialized tools like Popup Inspector to monitor andblock pop-ups. Make sure pop-ups from our sites are enabled in these tools. If theproblem persists, try disabling / uninstalling these tools.

VIII. DCI does not come up in Acrobat window

Reason:

IE link to Acrobat broken

Fix:Reinstall Acrobat Reader, and RDC plugin

Reason: Popup blocker enabled

Fix:Enable pop-ups from rt1.cceb.med.upenn.edu in IE


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Note: Some add-ons, like Google Toolbar, have pop-up blocker functions. Also, usercould have installed specialized tools like Popup Inspector. Make sure pop-ups from oursites are enabled in these tools. If problems still persist. The user may want to disable /uninstall these add-ons

IX. Get "Cannot contact host 127.0.0.1 port 5567" when opening a DCI form

Reason:

Improper setting in Jinitiator 1.1.8.24

Fix:Go in Start/Programs/Jinitiator 1.1.8.24 Control Panel and change Network Access to'Unrestricted'. Hit 'Apply' button and exit

Reason: A local firewall may be blocking port 5567Fix: Windows firewall or a tool like Symantec Internet Security Suite may be blockingAcrobat from using the PDF plugin. Try to enable local traffic on that port you may needyour IT person help) and retry.

X. IE crashes while launching RDC

Reason:JIT compiler enabled in IE

Fix:Go in Internet Options/Security. Select Internet zone for RT1. Select 'Custom Level' anduncheck 'Enable JIT compiler' (Usually this issue happens in IE 6.0 with MS JVMinstalled)

XI. IE crashes (GPF) while launching Medication Reference tool

Reason:

Third party IE add-ons

Fix: Go to 'Manage Add-ons' and disable any 'Windows Live..', 'Google...', 'Yahoo ...', orAOL add-on

Note: Oracle has a possible workaround for this issue, but we are still testing it at thistime. It requires substituting jvm.dll in Jinitiator' Hotspot folder with JDK 6's one.


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2. Users can either access the Main Landing Page of RDC via the CATT Landing Pageas described above, or by entering the following URL -http://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htm - for RDC into an InternetExplorer web-browser and click on the Login button to launch the application.

Note: Users will be given access to the CATT training database initially, andafter they have been certified, the user will be given access to the live studydatabase. A News Item (described in the next section, page 18) will inform theuser as to which database they are accessing.

http://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htmhttp://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htm


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3. In the Log-in box enter the Username, Password, and Database name provided bythe CRCU Database Administrator:

Username: ________________________________________

Password: ________________________________________

Database: ________________________________________

After entering all of the information in the LOGON fields, click on CONNECT

** Note: This Username and Password will be used for allapplications that will be accessed by the User**

It is important that you keep your login information confidential. This information acts asan electronic signature, and attaches your name to any changes, updates, additions, ormodifications within the Oracle Clinical system and can be tracked through the Audit Trail.



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Oracle Clinical Remote Data CaptureNavigation and General Overview

1. News Items:

After logging into Oracle Clinical Remote Data Capture (RDC), the first screenencountered by the user is the News Item screen.

News items group, site, or individual messages can be created by users whohave access to the administration module of Oracle Clinical.

These news items will be the first screen displayed after a user has logged into thesystem and can help disseminate valuable study information to users.

News items are displayed anytime a user logs-in to the system, and are usuallydisplayed for a predetermined amount of time.

In the example above, the message reads: Welcome to the CATT TrainingEnvironment. Please note this database is for testing / training purposes only. Donot enter study data for any enrolled participants. This message signifies that theuser has entered into the training environment.

To move onto the next screen, click OK.



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2a. The Navigation Paneof the activity list with the site node expanded is outlined below.

The navigation pane with clickable nodes presents a hierarchical listing of the currentstudy, site listings, and assigned patient positions. To expand a node click on the +

sign. To contract a node click on the - sign.

The branching diagram above shows the individual nodes associated with the CATTstudy:

Study: CATT Site: CATT 30-1 Patients: 30100 30114

In the example above, none of the patients have beenregistered.



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In the example above, patients 30189, 30194, 30195, 30196,30197, 30198, and 30199 have data entered into the system,this is signified by the icon of a person to the left of the patientnumber.

30195 30199s icons are red because these patients currently

have outstanding discrepancies.



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2b. The Task Paneof the activity list is outlined below.


The Task Pane presents a listing of activities, or tasks associated with the currently

selected node in the navigation pane.

By clicking on a task, Remote Data Capture (RDC) retrieves the data necessary tocomplete the task from the study database.

In the example above, RDC will allow users to review discrepancies or Show All Datafor CATT. These tasks can be limited to site CATT30-1 (or an individual patientwithin the site), by clicking on the node that says Site: CATT 30-1 in the NavigationPane (example outlined below).


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2c. The Search Windowof the activity list is outlined below.

The search window provides access to different criteria, which can be modified fromdefault values that the system combines to retrieve CRFs from the study database.

Load Filter, will allow the user to load any saved study searches. Itwill limit the scope of the data displayed in the Navigation and Taskpanes of the Activity List, as well as populate the main menu basedon the saved search parameters. It allows the user to generate amore discrete and focused workset that is still based on a specificactivity.

Search, will allow a user to define search criteria, which can bemodified from default values that the system combines to retrieveCRFs from the study database. (See example of the search screendisplay on the next page).

Cancel, will present the user with three options: Change Study,Exit RDC, or Return to Search.

Help, will provide the user with more information on the Activity Listand give them the ability to search for keywords or topics for furtherinformation.



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Book this will allow users to specify a study for viewing data.

Site this will allow users to specify individual sites or all sites.

Patients this will allow users to specify a patient, a set of patient, or allpatients.

Visits / Pages this will allow users to specify individual visits, groups of

visits, or all visits and or pages.

CRF Status this will allow users to view specific CRFs with activediscrepancies, no discrepancies, locked, or all CRFs.

Date Window this will allow users to view data for a specific date, arange of dates, or all dates.

Data this will allow users to view data for specific CRFs, sections, labranges, comment types, etc.

Click OK to run the defined search parameters.

Click Load Search to load a previously saved search.

Click Cancel to exit this screen.

The Change Study button is not applicable to the CATT study. This button is used byindividuals who have multiple studies within RDC and allows them the ability to switch fromone study to another.


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2d. Summary Data and Statistics are displayed in the Summary tab located below the ActivityList pane, outlined below.

The left hand box provides Study Information Study title, number of sites, and

overall site participant summaries.

The right hand box provides Study CRF Information (for an individual site) numberof CRFs (both planned and unplanned), number of CRFs that have been verified,number of CRFs with discrepancies (active, other, and clean), number of CRFs thathave been approved, and the number of CRFs that have been locked.



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3. Other command buttons and drop menus from the Activity List / Oracle Clinical Tool Bar:

The command buttons are outlined above, please see the following pages for furtherexplanations.



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The person with a gold star (first icon) will allow a user to insert a new patient. Whenthis button is toggled, a drop down box of predefined Patient Identification Numbers(PIDs) will be displayed; the user can select the appropriate number and begin dataentry.

The gold disk (second icon) will allow a user to save any data they are currentlyworking on.

The page with an arrow pointing left (third icon) and the page with an arrow pointingright (fourth icon). These buttons allow a user to move to a previous or next CRF.

The face with quotation bubble (fifth icon) will allow a user to display InvestigatorComments This feature is not being used for this study.

The two-tone page with a star (sixth icon), will allow a user to display any active(open) or other (manually created) queries.

Finally, the blue Question mark will allow a user to access the help menu.



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3a. Based on the current view (Activity List) some of the functions in the drop downOracle Clinical tool bar will not be accessible. These options become activewhen the user moves from the Activity List to the Main Menu Screen.

The drop down Oracle Clinical tool bar is outlined above, each element isdescribed on the following pages.



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Edit:

The only options available from the Edit drop down menu in the Activity List view are:Preferences and Maintain Search.

The other Edit options Cut, Copy, Paste, Duplicate Field allow a user to cut, copy,paste, or duplicate field responses when performing data entry.

Delete CRF and Field Editor are not always active privileges for a user, these are highlevel functions that allow data managers, study officers, and designated personnel to:

Delete CRF clear CRF answers (if a CRF was mistakenly enteredunder the wrong PID).

Field Editor allows a user to edit the length, acceptable values, andother elements of a given data element.

Discrepancy, Discrepancy (manual), Section Discrepancy, and Investigator comments

will allow users to access individual discrepancies, discrepancy definitions, discrepanciesfor a given section, and let them view Investigator comments.

Preferences if active based on your user role will allows a user to modify their displaypreferences for example, as a user preference individuals can set their date displayformat to 01-JUL-2007 instead of 07-01-2007

Maintain Search allows a user to view their complete list of saved searches. From thiswindow the user can modify, delete, or change any of their saved searches.



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Insert:

The only options available from the Insert drop down menu in the Activity List view are:Patient, CRF, and Visit.

Patient this option will allow a user to enter a new patient. Afterselecting patient, a drop down window with a list of PIDs will appear andallow the user to select a patient number.

CRF this option will allow a user to enter a new CRF. After selecting

CRF, a drop down window with a list of CRF abbreviation names willappear and allow the user to select a CRF for a specific patient.

Visit this option will add an unplanned visit after the current visits. Usethis option only if the user has unplanned visit data. This will be used asthe preferred means to insert additional Treatment Evaluation (TE)forms.

The options not available from the Insert drop down are:

Discrepancy (manual) allows a user to create a discrepancy on aspecific question.

Section Discrepancy allows a user to create a series of discrepancieson a given section of a CRF.

Investigator Comment provides a pop-up comment field to be attachedto any question. This comment field can be used to write in anyadditional notations, comments, or questions. Users must have theappropriate privilege in order to insert an Investigator Comment.



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CRF:

None of the options from the CRF drop down menu are active in the Activity List View.To activate these menu options the user must be in the Main Spreadsheet or the DataEntry screen.

Previous Move from the current CRF to the previous CRF within a visitwindow.

Next Move from the current CRF to the next CRF within a visit window.

Insert Row This option is only active for those CRFs that haverepeating rows of values. This will insert an additional row for data entry.

Delete Row This option is only active for those CRFs that haverepeating rows of values. This will delete rows.

Lock If a user has the appropriate permissions, they will be able toLock a CRF. This is not used for the CATT Study.

Unlock If a user has the appropriate permissions, they will be able toUnlock a previously locked CRF. This is not used for the CATT Study.



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Group Activities:

None of the options from the Group Activities drop down menu are active in the ActivityList View. To activate these menu options the user must be in the Main Menu and havethe appropriate permissions and privileges. These features will not be used for theCATT Study.

These options allow for validation, approval, and locking of CRFs (individually, specificpatient, entire site, or entire study).

This role is only assigned to a few core study personnel, and will not be described indetail. The users needing to access this drop down box will be given specific instructionsand training.



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Validate:

The Validate drop down menu will allow a user to run validation on a specific Patient,Site, or Study.

o Patient this option will run validation on all of the CRFs that have been enteredfor an individual patient.

o Site this option will run validation on all of the CRFs entered for a given site.

o Study this option will run validation on all of the CRFs entered for the entireCATT study.

After validation has been run, those data elements that need correction will appear asRed CRF pages in the Main Spreadsheet view.



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Help:

The Help drop down menu will give users the ability to search for help topics, give usefulhints, and allow users to query an external Oracle Clinical web-page for additional helptopics and search options.



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Window:

The Window drop down menu will let a user change from one open Oracle Clinicalwindow to another, allow a user to change the way tiles are oriented, or allow a user tocascade the windows.

The views will stack open windows based upon the options selected.



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4. After selecting the hyper link: Show All Data for CATT from the task pane of the activity

list window, the main Oracle Clinical spreadsheet screen should be displayed. Thisscreen will be referred to as the Main Spreadsheet.


The current view (All patients, all pages) is displayed in the white bar under thespreadsheet outlined above. These views are dependent upon a users role and for

this example; the user only has access to Site 30-1 and will only be displayed data forthat site.

If any of the criteria had been changed from the Search Window or Activity List, it wouldbe displayed here (See below for two examples of different search criteria).

To return to the Activity List, press the toggle that says Activity List.


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4a. Visits for this study run horizontally across the top of the Main Spreadsheet, and areoutlined below.


The top portion the tabs represents individual visit numbers. In the example above,

Weeks 000 100 are displayed.

The blue boxes under the tabs represent individual forms within a given visit. In theexample above, the first form for Week 000 is a PR (Patient Registration) form.

Some forms, like the Additional Information on Women of Childbearing Potential (CP),can be accessed by clicking on the Show Unplanned Pages box.


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To access additional Weeks, not currently displayed in the Main Spreadsheet, click onthe double arrow button at the end of the Weeks tabs.

Clicking on this arrow will display all Weeks in a drop down menu for the CATT study:

From the drop down list, the user can access Weeks 104, PRN, AE, and CMED.

Note: If the user cannot see the full drop down list, they may need to adjust their computerscreen resolution.



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4b. Study Participants for this study run vertically down the left hand side of the MainSpreadsheet and are outlined below.

The individual rectangles will display the Patients. In the example above, there are 8

patients displayed.

As a study acquires more registered participants, a drop down menu will appear abovethe Participants column and allows for sorting / displaying of those participants enrolled ata particular study site.



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4c. Summary and Statistical data are listed in the Summary Tab, outlined below.

Similar to the Summary Tab located on the Activity List, this summary tab will allow auser to view summary data based on Patient, Page, CRF, or Visit.



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Patient drop-down option, provides the statistics and summaries for a given patient make sure you have highlighted one of the patient numbers running down the verticalside of the spreadsheet above the Summary tab section:

The first statistics column displayed here, Patient Summary, is a summary of the patientdemographics:

Patient: 30150 Initials: BVNI This is the Alpha Code Birthdate: 01-DEC-1962

Sex: M Age: 65 Site: CATT 30-1

The second statistics column displayed here, Discrepancies, is a summary of alldiscrepancies based on edit checks and validation for this patient :

This column will display the total number of discrepancies for the patient.It is possible for multiple fields on a given CRF to create activediscrepancies; each of these multiple discrepancies would be countedand listed in this column.

In the example above, there are no active (open), no other (manuallygenerated), and no closed queries / discrepancies for this patient.

The third statistics column displayed here, CRFs, is a summary of CRFs for this patient:

This column will display the total number of CRFs with active (open) andother (manually generated) discrepancies, and clean CRFs for this study.

This will display the number of open discrepancies at a CRF level,meaning that if a CRF has 5 open discrepancies it is only counted as 1 inthis summary.

The fourth statistics column displayed here, CRF Status, is not used for the CATTStudy. This column is a summary of CRFs that have been verified (or validated),meaning that validation rules have been run against the saved data.

The fifth and final statistics column displayed here, Visits, shows the current visit (000 in the case above), current entry dates, any dates data was updated, future visits anddates (based on a visit window), and lists any missing pages / CRFs.



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Page drop down option, provides the statistics and summaries for an individual page(click in one of the CRF boxes in the spreadsheet):

The first statistics column displayed here, Patient Summary, details the page number,visit, CRF name, and Site for a selected CRF.

The second statistics column displayed here, CRFs, shows the number of active (open),other (manually generated), and clean discrepancies for a selected CRF. This columnalso shows when data entry began entering this CRF and the date the CRF was updated.

The third and final statistics column displayed here, CRF Status, will display data basedon the verification and approval processes for this study. This will not be used for theCATT Study.



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CRF drop down option, provides the statistics and summaries for a selected CRF (click inone of the CRF boxes in the spreadsheet):

The first statistics column displayed here, CRF Summary, provides the basic informationfor a selected CRF. In the example above, we can see:

Patient: 30150 Visit: 000

Page Number: 1 CRF: PR Date: Blank this field is not in use for the CATT Study Document Number: This is a unique number that gets assigned by

the system for each individual CRF that getscreated within Oracle Clinical.

Status: Entry Complete This status will change based on theData Entry Status of the CRF.

The Data Entry Statuses are:

Entry Started CRF entry begun, but saved as incomplete. Entry Complete CRF entered and saved as complete. Verified CRF entered, saved, and validation / discrepancies have been

run against the entered data. This will not be used for the CATTStudy.

Approved CRF entered, saved, validated, and approval has been givenby a study designated approver (PI, Clinician, etc). This will not beused for the CATT Study.

The second and final statistics column displayed here, Audit Summary, displays a basicaudit trail of the data entry and most recent activity on a selected CRF.

The top portion shows who initially created the CRF based on theirunique login and also shows the date and timestamp for when the CRFwas created.

The bottom portion shows the most recent modifications date andtimestamp, the most recent transactions date and timestamp, and whoperformed either of these functions.



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Visit drop down option, provides the statistics and summaries for a selected visit tab (clickon the visit tab at the top of the spreadsheet):

The first statistics column displayed here, # Patients, details the number of patients s whohave been entered for the selected visit (in this case visit 000, selected from the Visit Tabat the top of the spreadsheet).

The second statistics column displayed here, Summary of CRFs Retrieved, gives an

overall snap shot of the number of CRFs that have been data entered for this study.

Planned / Unplanned lists the number of CRFs that are planned (partof the visit schedule) and Unplanned (any collected data that is not partof the approved visit schedule for this study).

With active descreps / with other discreps / clean details the number ofopen discrepancies and the number of cleaned / corrected CRFs.

Not verified / Awaiting re-verification / Verified details the number ofCRFs that have not been and have been validated, and also the numberof CRFs in the process of being re-verified. This will not be used forthe CATT Study.

Not approved / Awaiting re-approval / Approved details the number ofCRFs that have not been and have been approved by a designatedapprover (PI, Clinician, etc), and also the number of CRFs in the processof being re-approved. This will not be used for the CATT Study.

The third and final statistics column displayed here, Summary of CRFs in Current Tab,gives a snapshot of the number of CRFs that have been data entered for a selected visit(in the example above, visit 000). The categories listed in this column are similar to thecategories listed in column two; however, the metrics in column three pertain only to theselected visit.



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Oracle Clinical Remote Data CapturePrinting Case Report Forms (CRFs)

Prior to seeing a patient in the clinic, the user should print Case Report Forms (CRFs) from theCATT Main Landing Page, or make copies of existing blank CRFs

4.

CRFs can be printed from the CATT Landing Page:

This is the preferred method of printing for this study, as the CRFs

will be arraigned in packets by Visit Week.

CRFs can also be printed directly from RDC in two different ways:

Visit specific pdfs from the Links tab

Individual pdfs from a current pdf

Prior to printing, check with your local administrator to insure that your computer hasbeen setup to print to your local printer as your default printing option.

Also check to make sure that Adobe has also been configured to print toyour default printer.

4If the user makes copies of existing blank CRFs, they need to verify that they are using the most current / approved

CRFs for the study.


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1. Printing Case Report Forms (CRFs) as pdfs from the CATT Landing Page.

This option provides a hyperlink to take the user to a secure internet portal, which willallow the user to select and print specific blank CRFs for a given visit, as well as, visitpackets.

NOTE: This is the preferred method for printing CRF Visit Packets for this study.

To Print visit specific CRFs as pdfs, navigate to the CATT Landing Page and select thehyperlink titled CATT Case Report Forms by Visit or CATT Case Report Forms Individual, as shown below:

CATT Case Report Forms by Visit will provide the user with Visit Packets for each of thestudy weeks.

CATT Case Report Forms Individual will give the user access to individual CRFsarraigned by category:

o Insert CRF Formso PRN Formso Ongoing Logso Retain At Clinico Fax to Coordinating Centero Submit to Fundus Photograph Reading Center



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When a packet is opened, the first page will contain a data processing coversheet. Thissheet will provide some general instructions about the packet, associated forms, andprocedures.

In the example above, Week 000 All Baseline Forms was opened; the first pagepresented is the Baseline Data Processing Cover Sheet.

This sheet provides some general information about the baseline packet:

o FORMS this column lists all of the forms provided in the packet. However, anyforms listed under the subheadings Insert CRF Forms, PRN Forms, OngoingLogs, Retain at Clinic, Fax to Coordinating Center, or Submit to FundusPhotograph Center are use as needed forms and must be accessed from theCATT Case Report Forms Individual hyperlink from the CATT Main Landing

Page.

o ADDITIONAL REQUIREMENTS this column will list any additional proceduresthat are required at a given visit for example Week 024 All Follow-Up Formshas additional requirements, see example on the next page:



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The final portion on all Data Processing Coversheets:

o REVIEW COMPLETED CRFs & ENTRY this section at the bottom of eachData Processing Cover Sheet should be used for Quality Control (QC) / QualityAssurance (QA) purposes. It should capture who reviewed the completed formsprior to data entry, who performed the data entry, the dates these activities wereperformed, and provides space for any comments about quality, problems, ornotations.



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These PDFs packets will allow users to enter the CRF header information, and will allowthe forms to be populated with patient specific data.

Once the PDF is open, click on the Hand Icon:


Move the Icon next to the header word ID. No. to begin typing.

After entering the ID No., hit tab and the cursor will automatically move to Alpha Code.Enter the Alpha Code and hit tab. Enter the Clinic # and hit tab. Enter the Site # and hittab. Finally Enter the Week and hit tab.

The header information will then populate across all of the forms in the pdf packet.

Print the packet and the pages will be printed out with the header information pre-populated on the form.

o To print the pdf, click on File from the tool bar and select Print, oro Click on the printer icon.


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1b. To open the CATT Case Report Forms (CRFs) by visit, click on the link CATT Case Report

Forms - Individual from the CATT Main Landing Page, and the following page will appear:

This page contains hyperlinks for all of the Individual CATT CRFs, which are listed underthe following subheadings:

o Insert CRF Formso PRN Formso Ongoing Logso Retain At Clinico Fax to Coordinating Centero Submit to Fundus Photograph Reading Center

These Individual CATT CRFs are not included in the Visit Packets, and should be printedas needed.



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The Individual CATT CRFs are accessed by clicking on the hyperlink listed under thesubheading. In the example below, Additional Information on Women of ChildbearingPotential Form was selected:

Just as in the example of the CATT Visit Packet, the header of this form has beenenabled with the auto-populate feature.

o Follow the same directions for typing in the header information (ID. No., AlphaCode, Clinic #, and Week), and then print the form.



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2. Printing Case Report Forms (CRFs) from an open pdf within Oracle Clinical.

After opening a pdf for Data Entry within RDC from the main spreadsheet view, the usercan print the pdf, by clicking on the printer icon in the pdf tool bar, outlined below.


The user will only be able to print the CRF they currently have open.


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Oracle Clinical Remote Data CaptureAccessing Study Tools Adverse Event Coding and

Concomitant Medication Coding

This section will describe how to use the CATT Main Landing Page to perform all of the followingstudy related activities:

Accessing External Links for Adverse Event Coding

Accessing External Links for Concomitant Medication Coding

Report access and printing of a Patient specific reports Visit Schedules andRandomization Assignments


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1. Accessing External Links for Adverse Event Coding, will give the user information that

should be recorded on a paper Adverse Event form prior to completing data entry in theOracle Clinical Remote Data Capture (RDC) interface.

Important Note: This link will access a web page outside of Oracle Clinical Remote DataCapture (RDC). This link is maintained by the National Institutes of Health (NIH).Problems arising from connectivity, usage, or performance cannot be addressed bymembers of the CRCU, CPOB, nor the CC. Help and Support for this page can only be

supplied by NIH via their help menu located on the screen.

To access the external link for Adverse Event Coding, navigate to the CATT MainLanding Page. Search for the hyperlink titled Adverse Event Coding Reference Tool(NIH) and click on this link to launch the Common Terminology Criteria for AdverseEvents (CTCAE) guide provided by the NIH:

The main page of the Adverse Event Coding Reference Tool (NIH) page will open in aseparate browser window.



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The CTCAE guide allows a user to search by Category, or by term (both literal andkeyword searches), see outlined below.

o Category searches can be completed by clicking on the down arrow next to theword All Categories. The user will be presented with a drop down list of bodysystems. If a body system is selected, the most common ailments will bepresented and the user can scroll through the various conditions.



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o Term searches can be completed by typing text into the Search for field. Thistype of search will allow you to search for a Literal or Keyword term.

Keyword searches will search for the term entered across multiplefields, checking for the term in name fields, body systems, categories,and descriptions. This type of search will return any items matching thekeyword term entered.



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This description is very important inhelping to code, grade, and enter theAdverse Event (AE).

If this is the Adverse Event the userwants to use to describe the event,write down the following:

o MedDRA Code Number.o MedDRA Short Name.o MedDRA Grade.

These items will then be entered fromthe paper copy of the Adverse EventRecording Form into RDC.

If this description does not match theAdverse Event the user wants to use,try searching again or use the Literalsearch option.

Remark is a very important field, as itcontains descriptive data that canhelp the user make a determinationas to whether or not the AE selectedappropriately describes the condition.


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o Literal searches will search for the term entered in the name fields.

In the example above, Headache was entered as the term. The Literalbutton was toggled a list of items were returned.

By clicking on the item that matches the Adverse Event in this case,Flu-like syndrome the CTCAE will retrieve a description and providegrading criteria, see example on next page.



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The alphabet bar (see below), allows the user To limit the search results alphabetically,click one of the alphabet buttons (that is, #ab, cde, fgh, ijk, lmn, opq, rst, uvw, or xyz)below the Search for field or within the adverse event details (where applicable).

The default is to view all results.



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2. Accessing Additional Adverse Event Pages

Additional Adverse Event Log pages have been provided, and can be accessed from theAE tab. To access additional pages:

o Click in the blue box that says Show unplanned pages, outlined below:


o The view will change and show 10 available AE pages, outlined below:


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o After displaying all available AE pages, the user will need to select the next page,

and uncheck the blank flag processing:



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o To activate the page for data entry, click on the CRF Blank check mark, ando A Reason for Change box will appearo Click OK


o After clicking OK, the user will be able to enter data into the CRF

o Save the form after entering data.o Repeat these steps as needed for additional pages.


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After logging in, the Medication Tool Reference search window will be displayed:

This window is divided by 3 sections:

o Enter Query Criteria This section allows the user to enter and query for drugsbased by either Brand Name, Generic Name, or Drug

Code.

o Sort Criteria This section allows the user to sort their query entry byDrug Code, Brand Name, or Generic Name. It isrecommended for this study that the User sorts andrecords events using the Generic Name.

o Drug Names and Codes This section displays the data queried and sorts itbased on the criteria entered by the User.



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To search medications by Brand Name, make sure the radio button next to Brand Namehas been selected, then enter the text of the drug to be searched for, and click on thebutton Execute Query. In the example below we are searching for aspirin:


After the query has returned results, use the scroll bar to search the list for the mostappropriate drug name.

Then write the code down on the Concomitant Medication Log. This information will thenbe used to enter the Medication code into Oracle Clinical RDC.

Repeat this search as need, based on the medications recorded during the clinic visit. IfBrand Name is not working as query, try searching the term using the Generic Namequery.


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If the complete spelling of a medication is unknown, the user can enter the first 2-3characters and % to search for any term that begins with those characters:

This type of search is referred to as a Wildcard Search, and will return any medication inthe database that has asp in the Brand Name.

Wildcard searches can be applied to the Generic Name and Drug Code search bars.



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To search medications by Generic Name, make sure the radio button next to GenericName has been selected, then enter the text of the drug to be searched for, and click onthe button Execute Query. In the example below we are searching for aspirin:


Then write the code down on the Concomitant Medication Log. This information will thenbe used to enter the Medication code into Oracle Clinical RDC.

Repeat this search as need, based on the medications recorded during the clinic visit.



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To look up, or verify that the correct Drug Code was used, make sure the radio buttonnext to Drug Code has been selected, then enter the code number of the drug to besearched for, and click on the button Execute Query. In the example below we aresearching for 1820:


Repeat this search as often as need to look up drug names based on a code number, orto verify that a number correctly matches a drug name.



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After obtaining the Medication Code, the user can use the auto-populate feature to enterthe Drug Code on the Concomitant Medication Log (CMED) within RDC.

Type the code in the column titled Drug Code and Tab, the cursor will skip the columntitled Medication Name and will move to Rx. After the form has been Saved Complete,the generic drug names associated to the code entered will be displayed.

If there was a typo or transcription error, the erroneous codes will display an errormessage of Medication not found:


o Double-check that the code was entered correctly from the CRF, oro Return to the Medication Reference Tool and search for the drug code again


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To change the erroneous code, click in the Drug Code box.

o Remove the Code for Medication not found, theno Type in the correct code

A Reason for Change dialog box will open.

o From the Reason drop-down menu, select a reason for change that best fits thecorrection reason.

o An optional comment may be typed in the text box in the example below thereason states Mistyped the Drug Code 02jan2008tdc.

o Click oko Save the form and the correct Medication Name will now be displayed.



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Oracle Clinical Remote Data CaptureGeneral Data Entry Instructions

Data Entry is performed from the Main Spreadsheet of Oracle Clinical RDC.

From here, CRFs can be entered, viewed, or updated for registered patients.

If a user is entering data for a new patient, they will first need to register theparticipant (see pages 83-86 for registration instructions).

If a user is entering data for an existing patient, they can navigate to the appropriatevisit, select either a CRF to complete data entry, or click in one of the white boxes tobegin data entry on a new form (see pages 87-95 for data entry instructions).



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The following keys will help explain the icons displayed in the Main MenuSpreadsheet:

Blank an entry status designation that is assigned to a CRF a user has defined asblank. A blank CRF does not contain data, nor can data be collected while it is markedblank.

Created an entry status designation that is assigned to a CRF when all required CRFheader data has been entered and saved, and no other data (i.e.: response data) hasbeen entered.

Entry started an entry status that is assigned to a CRF in which data entry has been

initiated but is not complete. CRFs are assigned this entry status because: Some required data fields are complete, while some are not. The CRF has been saved in an incomplete status.

Entry Complete an entry status that is assigned to a CRF in which all required fieldshave been entered, including CRF header fields and Question area response datapoints.

Active a discrepancy status that indicates the relevant discrepancy is

actionable by members of the user group.



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1. To register a patient for the first time:

Click on the plus sign beside the site name from the Activity List.

A branching diagram of all assigned patient positions for that site will be displayed.

Click on the patient you wish to begin data entry for.

A hyperlink titled Begin New Data Entry for Patient # # # # # will appear in the Task Pane,in the example below Patient 55100 has been selected.

By clicking on the hyperlink, the user will be taken to the Main Spreadsheet view of RDCand can begin data entry.



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1a. After the first patient has been registered at a site, further patients can be added by:

Clicking on the icon of the Person with a gold star, or

Clicking on Insert from the drop down tool bar menu, and select Patient, or

Clicking on a blank white rectangle (or selecting the next available patient position) in the

patient section of the spreadsheet.



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Click on the Participant Identification Number that you wish to create / enter data for, andthe system will automatically insert the patient and open up all of the study visit CRFs fordata entry:

In the example above, patient 30100 has just been inserted and all associated studyvisits are now available for data entry.



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2. To enter planned CRF data for a patient:

Click on an existing CRF icon, or

Click on a white box within the Oracle spreadsheet whose coordinates intersect based onpatient number and CRF name.



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2a. To enter a new CRF, click in one of the white boxes, an icon with just a header willappear, and a separate pdf applet will open for data entry:



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Data entry can be completed in a number of ways:

Selecting values from a drop down menu called a list of values, or Clicking on an answer with the mouse cursor, or Date fields can be entered manually or by clicking on the pop-up window

(as in the example below), or Tabbing from one field to another.

List of Values:


In the example above, outlined in yellow, a list of values is displayed by clicking onthe grey box outlined by a blue dashed border. The user can either highlight theappropriate response and press ok; or cancel and type the number of the answerthey want in the line to the left of the grey box.


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2b. To enter data into a CRF with the status of entry started, simply click on the page icon

to open the form for data entry:

In the example above, there are three different CRF statuses for patient X7 (XYZ):

The first box from the left, displays a CRF that only has had its headerinformation entered.

The middle box, displays a CRF that has been partially entered.

The last box, displays a CRF that has had all data point questionsanswered.

The first and middle boxes have been Saved Incomplete so that a user can return to itand complete data entry. The last box has been Saved Complete, and can only be

updated by an individual who has update privileges.

Data Entry for CRFs with the status of entry started follows the same general guidelinesas outlined in #3a.

o If a form was saved incomplete but all of the answers on the form werecompleted, the user will need to change at least one item on the form in order tobe presented with the save complete option.



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Oracle Clinical Remote Data CaptureDiscrepancy Management

Discrepancy management refers to a process that systematically addresses discrepancies(queries) generated within a study. Discrepancy management attempts to identify the cause andassess the implications of each discrepancy and determine an appropriate action for thediscrepancy.

There are two basic types of discrepancies Univariate and Multivariate discrepancies:

Univariate discrepancies are discrepancies that are dependent on thevalue of a single data point. This type of discrepancy is usually triggeredwhen the value recorded for a response does not meet established dataentry criteria delineated by the protocol.

Multivariate discrepancies are discrepancies that are dependent on twoor more data point values, which can be within a single CRF or acrossmultiple CRFs and / or visits. Multivariate discrepancies are triggeredwhen a CRF is saved, which causes the system to run the validationprocedures that locate this type of discrepancy.

From the Activity List, after a user has first logged in, any open discrepancies for a site oruser will be detailed in the Task Pane:

The example above, outlined above, show that the user needs to Review 314 ActiveDiscrepancies for Site CATT 30-1.



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1. Accessing Discrepancies:

Users can either click on the hyperlink: Review 314 Active Discrepancies for SiteCATT 30-1, or users can enter the main menu view.

By clicking the hyper link, users be given a display that only shows the opendiscrepancies for this site.

By entering into the main menu view, users will be able to see all data for their siteincluding CRFs with errors and those without (see below).

Active or Open discrepancies are represented by a miniature CRF icon that is shaded inred, see outlined above.



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1a. To view discrepancies, click on the shaded CRF icon:



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To set all your pdf views to Show Discrepancies:

Click on the pdf Preferences icon on the toolbar,

Select the drop-down menu under the Default CRF Highlight area andselect Fields with Discrepancies. This will highlight all activediscrepancies, like the example on the previous page.

Click on Ok to save the preferences.



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To show the individual discrepancy reasons and error messages:

Click on the Discrepancy Manager icon in the toolbar,


Move the mouse cursor to the red highlighted CRF response(s),

Left-click the mouse to open the discrepancy description.

In the example above, a discrepancy has been triggered. The discrepancy states thatthe response cannot be left blank. This is an example of the types of discrepancies thatcould be encountered during the course of this study.

The discrepancy details, including the error message, are shown under the section titledDiscrepancy Error Details.


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To be able to access any of the other functions, after using the discrepancy managercursor, the user must select the Hand icon from the pdf toolbar:

Selecting the Hand icon will allow the user to return to a normal cursor, and will reactivefeatures like:

Save, Close, Previous, Next, and Help.

Allow the user to use the scroll bar within the pdf.

And allow the user to enter data into the individual data points within a given CRF.

You will then need to SAVE the page, in order to save the change and rerun

validation:

Repeat the above steps to review any active or outstanding discrepancies.



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2. General instructions for correcting errors:

To correct an error, click in the red highlighted field and change the error to thecorrect or appropriate answer.

A Reason for Change pop-up window will appear.

Select a Reason for Change from the drop-down menu that best describes why thechange is taking place.

There is a text box available for optional change comments.

Click Ok.



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2a. Discrepancies for sub-questions are at times presented in a hierarchical order, and canbe displayed within the same Discrepancy Window.

For example, Questions 2a and 2b of the TF form will be displayed within the samewindow:

When the user clicks on thediscrepancy for 2A, they will bepresented with the Discrepancy tothe left.

The Error Message provides thereason the discrepancy wastriggered: If Yes, at least onesymptom or discomfort must bechecked.



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When the user clicks on the discrepancy for 2B, they are presented with a discrepancywindow that contains two responses.

By clicking on the Tab Open Discrepancy the user can navigate between the twodiscrepancies (see outlined above).

The Question Information box at the top of the page will provide the user with informationabout the question in the example shown above, the discrepancy is for Question: Wasan office visit scheduled?

The Error Message provides the reason the discrepancy was triggered: Indicate if officevisit scheduled.



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2b. In some instances, values for given questions will need to be confirmed.

For example, the system has built in quality control checks for Race that will cause adiscrepancy to be triggered.

These discrepancies will need to be resolved in order to remove the red highlight.

In the example below, the user is being asked to Confirm the Racial Group entered.



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By clicking on the Discrepancy Manager Icon the user will be displayed with the errormessage:

In this example, Asian is the correct racial group and the action for this Open

Discrepancy will be Close resolved.

A second pop-up window will openand the user will need to provide aDiscrepancy Resolution Reason.

The user will be required to select areason from the drown menu.Written comments are optional.



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This indicates that the user confirmed the racial group for this subject to be Asian.



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3. How to create manual queries (discrepancies):

Navigate to the question that you would like to update with a manual query.

Click on the Discrepancy Manager icon in the tool bar.

Left-click on the question you would like to query.

The discrepancy manager pop-up window will open. Make sure you are on the AddDiscrepancy tab:



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Click Ok, and you will see that the discrepancy is now highlighted in red:

Remember to Save prior to closing or navigating away from this page.

One important note about Manual Queries these will need to also be resolvedmanually, just like in the example of Confirming Race (pages 105-108).

o If an answer is changed for a field with a manual query, it will remain red until thediscrepancy has been closed.



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Oracle Clinical Remote Data CaptureRandomization, Patient Visit Schedules, and Patient

Randomization Reports

This section contains information on how to Randomize patients. This section also describeshow the user can access patient specific reports Visit Schedules and Treatment Assignments after a patient has successfully been Randomized.

1. Patient Randomization:

Patient Randomization is accessed via the Week 000 tab from the Main Spreadsheetview.

Access the Randomization Form by clicking in the Randbox for the patient to berandomized.

Randomization can only be performed:

o By users assigned with Randomization privilege, ando After all necessary Baseline Data has been entered and saved complete with no

outstanding discrepancies.



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Answer Questions 1 and 2 appropriately, and save the form complete this will runvalidation and generate a Randomization Message (see section 4a for a list ofRandomization Messages).

In the example below, the randomization was successful. The Randomization Date has

populated and the user is given instructions on accessing and printing the RandomizationAssignment.

Randomization can only be performed by users that have been designated by theCoordinating Center (CC) to be unblinded.

To obtain the Dosing Schedule and Study Drug, the user will need to access the reportsas discussed in pages 116-122.



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3a. Randomization Messages are listed below and depending on outstanding validationrules, incorrect dates, or missing data these messages will be displayed and will need tobe addressed in order to successfully randomize a patient.

a. You are not authorized to perform randomizations. Contact the Coordinating Centerimmediately if you believe you are a certified Clinic Coordinator.

This message is returned if the user has not been assigned the necessary

permissions to randomize patients.

b. Eligibility Check Failed: Please review responses to forms with validation errors.

This message is displayed if any of the critical questions on the Baseline formsrequired for randomization have unresolved errors. The user will need to returnto the Main Spreadsheet View, search for any forms with open discrepancies,and address the outstanding validation errors.

c. Eligibility Check Failed: Unresolved Discrepancies Found.

This message is provided if any of the Baseline forms required for randomizationhave active discrepancies. The user will need to return to the Main SpreadsheetView, search for any forms with open discrepancies, and address the outstandingvalidation errors.

d. Eligibility Check Failed: Some required Baseline Forms were not entered.

This message is returned if any of the required forms for randomization aremissing; or if forms required for randomization have been saved incomplete. Theuser will need to return to the Main Spreadsheet View, and either enter themissing forms or update and save complete the forms required for BaselineRandomization.

e. Eligibility Check Failed: Time-dependent Checks Failed.

This message is displayed if any critical procedure dates or completion dates forBaseline forms required for randomization have been entered outside of theirexpected completion windows. The user will need to contact the CoordinatingCenter for instructions on how to proceed if this message is returned.

f. The patient has been randomized. Go to the Reports section of the CATT Landing Pagefor the assignment & treatment schedule:http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html.

This message is provided when the patient has been successfully randomized. Theuser can now return to the CATT Main Landing Page and access the reports for thispatient.
http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.htmlhttp://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html


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If Randomization Messages from items b d above are returned, the user will need tocheck for open discrepancies and resolve the errors, and / or enter any missing CRFs.After the errors have been resolved and all required Baseline forms have been savedcomplete, the user will need to run validation.

To validate a patient, click on Validate and select Patient:


The user will be asked to confirm validation for the patient selected in this case 30150.By clicking OK, the system will run the validation, and update randomization.

While validation is processing, an hourglass or wait cursor will be displayed. After themouse cursor returns to normal, indicating that the validation process has completed, theuser can open the randomization form and retrieve an updated randomization message.Assuming that all errors have been properly addressed, a successful randomizationmessage should be displayed.


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2. Report access and printing of a Patient Visit Calendar and Randomization Assignment:

To access the report link for a Patients Visit Calendar and Randomization Assignment,navigate to the CATT Main Landing Page. Search for the hyperlink titled Oracle ClinicalReports and click on this link to launch the Report Module.

In order to run either of these reports, the patient must first be Randomized by accessing

the RAND form, answering all necessary questions correctly, and obtaining a successfulRandomization Message. For information on how to randomize, refer to pages 112-116.



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After clicking on the Oracle Clinical Reports from the CATT Landing Page, the followingscreen will be displayed.

The user will be required to enter their Logon Credentials, in order to access the CATTStandard Reports module, shown below:



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The user will need to enter the PID (ID. No.) and also select the Site ID (Clinic Site) ofthe patient they wish to view / print a report for, see example below:


After selecting the Site ID from the drop-down box, the Site name will automaticallypopulate in the Site line:

After this information has been entered, the user can access the:Appointment Schedule Report this is the Visit Schedule.

o Baseline Treatment Assignment this is the Randomization Report.

Repeat the above steps Entering the PID and Site ID for each patient the user wouldlike to access, view, and / or print a report.


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Selecting the Appointment Schedule Reportbutton, will open the report as a pdfdocument, and can be printed and used as reference.

This report provides the open, expected, and close visit window dates for each of thepatients upcoming visits throughout the duration of the study. These dates arecalculated based on the date of a patients randomization.

o Also listed on this Visit Schedule Randomization Date, Clinic Number, SiteNumber, Study Eye, and Participant Number.

This form does not impact blinding, and after printing can be maintained in the patientsfile.

To navigate back to the CATT Main Landing Page:

o Close the Appointment Schedule by clicking on the red X in the upper righthand corner or by clicking on File and then Exit.

o The user will be taken back to the CATT Standard Reports menu, where the usercan access and print other reports or can exit by clicking Cancel.



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Selecting the Baseline Treatment Assignment Reportbutton, will open the report as a pdfdocument:

This report contains confidential information, and after printing it must be maintained in asecure location to protect the blinding of the study treatment.

The report provides information about the patients Randomization Date, Study Eye,Dosing Schedule, and Study Drug.

To navigate back to the CATT Main Landing Page:

o Close the Appointment Schedule by clicking on the red X in the upper righthand corner or by clicking on File and then Exit.

o The user will be taken back to the CATT Standard Reports menu, where the usercan access and print other reports or can exit by clicking Cancel.



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CATT List of Abbreviations

AE Adverse Event

CATT Comparison of Age-Related Macular Degeneration Treatment Trials

CC Coordinating Center

CCEB Center for Clinical Epidemiology and Biostatistics

CDM Clinical Data Management

CMED Concomitant Medication Log

CPOB Center for Preventive Opthalmology and Biostatistics

CRCU Clinical Research Computing Unit

CRF Case Report Form

CTCAE Common Terminology Criteria for Adverse Events

DM Data Manager

DMS Data Management System

FDA Food and Drug Administration

ICH International Conference on Harmonization

IE Internet Explorer

IFPMA International Federation of Pharmaceutical Manufacturers and Associations

INV Investigator

MedDRA Medical Dictionary for Regulatory Activities

NIH National Institutes of Health

OC Oracle Clinical

OPA Oracle Project AdministrationOS Operating System

PC Personal Computer

PDF Portable Document Format

PI Principal Investigator

PID Patient Identification Number

QA Quality Assurance

QC Quality Control

RC Research Coordinator

RDC Oracle Clinical Remote Data Capture

SAE Serious Adverse Event

SOM School of Medicine

SP Service Pack

UPENN University of Pennsylvania


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Oracle Clinical Glossary5

A

access keyThe keyboard key corresponds to the letter that is underlined in an items on-screen title. Theaccess key may be activated either singly or in combination with the ALT key.

activeA discrepancy statusthat indicates the relevant discrepancy is actionable by members of youruser group.

active modeIn PDF data entry mode, a status assigned to a CRF that allows the user (with appropriateprivilege) to modify the CRF. Although multiple CRFs may be open at one time, only one CRFmay be open in active mode.

audit historyThe set of all audit records for a given datapoint.

audit recordA set of information that describes an instance of data update. Each audit record includes thefollowing information:

the current value of the datapoint

the previous value of the datapoint

the username that changed the datapoint

the timestamp the data update occurred

the change reason

an optional comment

automatic progressionA feature of RDC that enhances user data entry, monitor verification, and investigator sessions.When automatic progression is enabled, as you complete work on the current CRF focus moves

to the next CRF in a sequence specified by the settings in the Preferences window. The nextCRF may be: within the current patient record, across Spreadsheet tabs; within the currentpatient, within the current event tab; or within the current CRF column.

NOTE: Based on system administrator settings, the Preferences window may notbe available in your session

B

blankAn entry statusdesignation that is assigned to a CRF a user has defined as blank. A Blank CRF

does not contain data, nor can data be collected while it is marked as blank.

browse1) A user action that entails reviewing existing data without adding new data or changing existingdata.

2) A privilege, specific to batch loaded CRFs, that provides the user with the ability to viewexisting data, but not to add new data or update existing data in CRFs.

5Abridged version of the Glossary from the RDC User Guide.


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