Investigator Site OC RDC 4.5.3 HTML User Guidestorage.ppdi.com/edc/html/reference/site/4.5.3_Site_User_Guide.pdf · Investigator Site User Guide (OC RDC) ... The Casebook Spreadsheet

Oracle® ClinicalRemote Data Capture 4.5.3 HTML

Investigator Site User Guide (OC RDC)

If you experience any problems with OC RDC, contact the EDC Support Center Toll free numbers and a Support Center email form can be found at http://edc.ppdi.com/html

Version 1.2 Page 1 of 44 June 22, 2010

PPD Proprietary Oracle is a registered trademark of Oracle Corporation.

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User Guide






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Accessing OC RDC Steps for Access 3 Logging On 4 Change Password 5 Computer and System Security 5 Study and Site 6

Navigating OC RDC Selecting and Opening a Casebook Spreadsheet 8 Icons for eCRFs 10 Selecting and Opening an eCRF 10 Navigation Tools 11 Toolbar Components of the eCRF 12 Right-click Functionality 12

Data Entry In OC RDC Data Capture Fields 13 Data Capture Tips 13 Modifying Saved Data 15 Marking an eCRF as Blank 16 Unmarking an eCRF as Blank 17 Inserting Additional Visits 18 Deleting a CRF 20 Investigator Comment 21

Discrepancy Management System Generated Discrepancy 22 Discrepancy Colors 23 Validation Error Window 24 Discrepancy Resolution During Data Entry 25 Discrepancy Resolution After Data Entry 26 CRF Navigator - Discrepancy Tab 27 Resolving Discrepancies 28 Routing Discrepancies 30 Viewing Discrepancy History 32

OC RDC Features Viewing Investigator Comment in the CRF Navigator 33 Audit History 34 CRF Search Feature 35 Patient Validation 38 Principal Investigator Approval Process 39 Logging Out Of OC RDC 42 OC RDC Training Support 43






AACCCCEESSSSIINNGG OOCC RRDDCC SStteeppss ffoorr AAcccceessss In order to gain access to Oracle Clinical Remote Data Capture 4.5.3 for this clinical trial, you must complete the following:

1. Perform Oracle Clinical Remote Data Capture (OC RDC) system training. 2. Complete and submit an online Training Completion Form. 3. Complete and submit an online RDC Account Request Form. 4. File your copy of the Training Completion form in your Study Binder.

You will receive your login information, via e-mail within 5 business days. If you do not receive your access information within 5 business days, please contact the EDC Support Center. For detailed instructions refer to the OC RDC 4.5.3 Online Training for Sites, Sponsors and External CRAs/Clinical Monitors document on the EDC Website in the User Reference Materials link. NOTE:

• PPD OC RDC 4.5.3 Training is only required to be performed once, regardless of the number of PPD OC RDC 4.5.3 studies you participate in.

• A PPD RDC Account Access Request Form must be completed for each study you

require access to.

• If you will be participating in User Acceptance Testing (UAT) for your study, you must complete training and submit all required forms prior to test access being granted.

• Add your study URL to your Internet Explorer Favorites folder list for rapid access to

your study website.






AACCCCEESSSSIINNGG OOCC RRDDCC ((ccoonntt..))

Logging On You will receive your user name and study URL, via email. Your password will be the one that you submitted in your Account Access Request Form. If you forget your password call the EDC Support Center.

• Navigate to the correct URL for your study. • Click the Login button on the edc.ppdi.com/ website specific to your study • (Server 1, Server 2 or Server 3) • Enter the OC RDC Username and Password.

o Text is not case sensitive. o Passwords will expire ever 90 days. o Passwords can not be reused. o The user is allowed three log on attempts after which the account will lock - call the

EDC Support Center to unlock the account. o DO NOT share your login information with anyone.

• Click the Login button.

Click Login button to access the Logon window






AACCCCEESSSSIINNGG OOCC RRDDCC ((ccoonntt..)) >> Change Password Change Password There are instances in which users are required to change their password:

• Upon initial log in • Every 90 days • As needed if users feel someone knows their password

To change your password:

• Click the Change Password link at the top any page.

• Enter your Old Password. • Enter your New Password. • Re-enter the New Password for confirmation. • Click on the Apply button.

Computer System and Security Security is an important issue when working with a remote data capture (RDC) system. To limit unauthorized access, security features have been incorporated in the OC RDC system. Users should log off of the OC RDC if they need to step away from the computer. If the computer is inactive (no keyboard or mouse activity) for a specified amount of time, the system automatically times out. Users will lose any unsaved work and they will need to log back into the system to continue working. The following message box displays:

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NNAAVVIIGGAATTIINNGG OOCC RRDDCC Study and Site The RDC Home tab displays after users have logged into OC RDC HTML, and will be the starting point for all activities.

The RDC Home Tab is used to select the patient(s) and data that you wish to view on the RDC main spreadsheet. The Home tab can be accessed at any time during the OC RDC HTML session.

The RDC Home Tab will display with a default Study and Site Patient Selection List. Other studies and/or sites can be accessed from the drop-down list(s). Summary information can be viewed by clicking on the Study and Site Summary link on the upper right-side of the Home Tab.






NNAAVVIIGGAATTIINNGG OOCC RRDDCC ((ccoonntt..)) >> Study and Site Patient summary information can be viewed by clicking on any given patient icon.

Also note that the icons have color coding, which indicate the presence or absence of discrepancies (data errors):

• Red indicates a discrepancy actionable to the person or user group logged into the system. • Yellow indicates a discrepancy actionable to someone within a different user group (i.e.

CRA, DM or PVG). • White indicates there are no discrepancies on the patient data. • A grey question mark indicates a patient number without data.






NNAAVVIIGGAATTIINNGG OOCC RRDDCC ((ccoonntt..)) >> CCaasseebbooookk SSpprreeaaddsshheeeett Selecting and Opening a Casebook Spreadsheet

• Navigate to the Patient Search area.

• Use the + sign to expand the Patient Search section. • Enter your assigned subject number in the first Range field, or use the Magnifying glass

icon to select a patient number from the List of Values available. • Click the Go button. • Place a checkmark in the box to the left of the desired patient number. • Click the Go button.






NNAAVVIIGGAATTIINNGG OOCC RRDDCC ((ccoonntt..)) >> Casebook Spreadsheet NOTE: Patients can also be selected directly from the Patient list area for the study site, as illustrated below. Using the Next 50 drop-down list or hyperlink is another way to display a different set of patient numbers:

• Place a checkmark in the box to the left of the desired patient number. • Click the Go button.

The Casebook Spreadsheet for the selected patient will display, once the Go button is clicked.

The Casebook Spreadsheet is the only page where you can initiate data entry for an electronic eCRF. The eCRF icons appear on the Casebook Spreadsheet. The eCRF is opened by clicking on its associated icon.






NNAAVVIIGGAATTIINNGG OOCC RRDDCC ((ccoonntt..)) >> Casebook Spreadsheet

Icons for eCRFs

Description Description Icon Icon

The eCRF has been marked as blank.

The eCRF has at least one open discrepancy that requires another users’ attention.

Blank CRF Other Discrepancy

Selecting and Opening an eCRF

• Click the Visit drop-down list. • Select the desired visit from the list.

Entry expected

No data has been entered yet. Verified

The eCRF has been source verified by the CRA.

Created

Header information present but no response data has been entered. The data on the page has been changed

since CRA verification. Requires Re-verification

All required CRF header and Section header information is complete and at least one question area response field is completed.

The eCRF has been approved by the Investigator.

Entry complete Approved

The data has been entered electronically via batch data load into the database by data management. (i.e. Central Lab, ECG) In some instances, batch loaded data may not be visible.

Data on the page has been changed since Investigator approval.

Batch Loaded Requires Re-Approval

All eCRF data has been collected and verified. A locked eCRF may be viewed in a read-only mode and its data cannot be updated. The locking task is typically performed by a data manager.

The eCRF has at least one open discrepancy that requires the current users’ attention.

Locked Active Discrepancy






NNAAVVIIGGAATTIINNGG OOCC RRDDCC ((ccoonntt..)) >> eCRF

• Click on the desired eCRF icon to open the page. • Maximize the eCRF window.

OC RDC Tools

Once the eCRF window is open a number of icons, links, and navigation buttons are available. Navigation Tools:

• To navigate through an eCRF that contains multiple pages, Navigation tools appear at the bottom of the eCRF.

• The navigation tool that appears at the top right corner of the eCRF is a toggle button for moving to the Previous CRF or the Next CRF.

• The TAB key moves the curser from field to field on the eCRF page.

• Clicking in a data field using the mouse moves the cursor to the selected data field.

• Use the scroll bars to navigate through and view the eCRF fields.






NNAAVVIIGGAATTIINNGG OOCC RRDDCC ((ccoonntt..)) >> eCRF

Toolbar Icons: • Toolbar icons are used as described below:

Toolbar Icons Name Description

Allows users to create new discrepancies or edit existing ones. Add Discrepancy

Investigator Comment

Allows site users to add comments to data fields.

Delete Row Allows site users to delete rows of data.

Blank Flag Tool Allows site users to mark the entire eCRF or one or more individual sections blank.

Verification (History) Allows CRAs to mark a eCRFs as verified and users to view verification history.

Allows investigators or designee to electronically approve eCRFs and users to view approval history. Approval (History)

Delete CRF Allows site users to delete eCRFs.

Print Allows users to print eCRF.

Save (Alt+S)

Right-click Functionality Right-click functionality is available when working in an eCRF. The popup menu that displays provides some of the same options as the Toolbar icons. On an open eCRF:

• Right-click on a data field to display the list. • Select the desired option from the list and proceed with the action selected.

Allows users to save their work.






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC Data Capture Fields There are different types of data entry fields. Some data entry fields contain a List of Values (LOV), which allows users to select a response from a pre-defined list. Other fields require users to click a checkbox or radio button.

1. Fields with List of Values When users tab or click into a field, and a magnifying glass icon appears to the right of the data entry field a List of Values (LOV) is available.

• Click on the magnifying glass to display the LOV. • Select a value from the list. • Click the OK button to populate the data entry field.

2. Checkbox or Radio Button • Use the Tab key to navigate to the checkbox or radio button. • Use the Mouse Cursor to select the desired response and double click to select, or

click on the desired response and click OK.

3. Free Text Fields If a field does not contain a LOV, text can be keyed into the field, and is automatically converted to uppercase.

Data Capture Tips The following data capture tips can assist with a data entry session: • If partial or unknown dates are allowed in the eCRF, use the List of Values (LOV) to select the

appropriate response. • Use the LOV when available to prevent data entry errors. • Use the Tab key to move from field to field or use the Mouse Cursor to click in a field. • Call the EDC Support Center for any technical difficulties. Worldwide toll-free numbers can be

found at http://edc.ppdi.com/html .

http://edc.ppdi.com/






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC ((ccoonntt..)) >> Data Capture Fields Data entry in OC RDC is performed on an open eCRF. Prior to beginning data capture, refer to your study specific eCRF completion guidelines.

Begin data entry on an open eCRF as discussed below:

• Begin entering data on the eCRF selected. • Click the Save icon. • Click the OK button. • Click the red X to close the window or navigate to the Previous CRF or Next CRF in this

visit using the buttons in the upper right of the window. • Click the Refresh button, to update the Casebook Spreadsheet.

Once all data has been entered, the eCRF will be saved as complete. This means that certain edit checks will fire upon the Save, and a change reason will need to be provided, if data is modified. Users are not prompted to provide a change reason if data is being entered on a field that previously had no data (null value).






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC ((ccoonntt..)) >> Modifying Modifying Saved Data There may be times when data needs to be added or modified after the eCRF has been saved as complete. The system automatically prompts users to provide a change reason through the use of the Reason for Change window when modifications occur on a completed eCRF.

To modify saved data • Open the desired eCRF. • Navigate to the field requiring modification • Modify the value in the field. If modifying the value in a checkbox, the Reason for Change

window displays as soon as the user clicks in the field. • Press the Tab key – Reason for Change window appears.

• Click the drop down arrow in the Reason field. • Select a reason for change from the list – in most cases, users should select Data Entry Error. • Add an optional comment, if desired. • Click the OK button to display the eCRF. • Click the Save icon. • Click the OK button. • Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit

using the buttons in the upper right of the window. • Click the Refresh button, to update the Casebook Spreadsheet.






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC ((ccoonntt..)) >> Blank eCRF Marking an eCRF as Blank If an entire eCRF or section within the eCRF will not be completed for a particular patient, or if a patient misses a protocol defined visit, the eCRF or section should be marked as blank.

Marking an eCRF as blank alerts the study team that the eCRF (or section) has not been inadvertently left blank. If an entire eCRF or section is marked as blank, users are not able to Tab to or use the mouse cursor to click in any data entry fields, as they will be grayed out.

Refer to the Study Specific eCRF Completion Guidelines for instructions on when it may be appropriate to mark an entire eCRF or section as blank. Users are also able to mark an eCRF that contains data as blank. All previously entered data on that eCRF page will be deleted.

• Open the eCRF which will be marked as blank; the eCRF displays.

• Click the Blank Flag Processing tool . The CRF Blank Section(s) Processing Window displays.

• Click the applicable check boxes to Mark an entire eCRF or Mark an eCRF section as

blank. • Click the OK button - the Reason for Change window displays if an eCRF that had been saved

as Complete is being marked as blank. • If applicable, click the drop down arrow and select a Reason for Change. • If applicable, click the OK button to close the Reason for Change Window. • Click the Save icon. • Click the OK button. • Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit

using the buttons in the upper right of the window. • Click the Refresh button, to update the Casebook Spreadsheet. NOTE: The OC RDC system will automatically mark any section as blank, for entire sections that are saved without data, within an eCRF. An entire page can also be saved as blank by using the Check if Entire Page Blank box, on the eCRF page itself.






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC ((ccoonntt..)) >> Blank eCRF Unmarking an eCRF as Blank The eCRF or sections marked as blank can be unmarked as blank to allow data to be entered on the eCRF. This is helpful if an eCRF or an eCRF section was marked blank in error, or if a patient did show up for the scheduled visit. To unmark an eCRF as blank • Open the eCRF that has been marked as blank.

• Click the Blank Flag Processing icon . The CRF Blank Section(s) Processing Window displays.

• Un-check the boxes to Mark an entire eCRF or Mark an eCRF section as blank. • Click the OK button - the Reason for Change window displays. • Click the drop down arrow and select a Reason for Change. • Click the OK button to close the Reason for Change Window. • Click the Save icon. • Click the OK button. • Click the red X to close the window or navigate to the Previous CRF or Next CRF in this visit

using the buttons in the upper right of the window. • Click the Refresh button, to update the Casebook Spreadsheet.






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC ((ccoonntt..)) >> Additional Visits Inserting Additional Visits Site users may need to manually add a visit page if they have completed data entry on an eCRF page, but still have more data to enter (i.e. Adverse Events, Medical History, ConMeds, etc.). The Study Team should advise when to insert additional visit pages based on the study protocol. You can add a new visit page to a visit from the Casebook Spreadsheet using the Add Visit Page button. Ensure that the new visit page is being added to the correct visit. Not all pages will be available for adding to the visit. Contact your study team regarding visits that are available for adding a visit page. To add a visit page:

• Select a visit from the Visit dropdown list. • Place a check mark in the box to the left of the desired patient icon in the Casebook

Spreadsheet.

• Click the Add Visit Page button. • The Add Visit Page dialog box opens, listing all the available CRFs for the current visit • Select the appropriate eCRF by clicking on the radio button.






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC ((ccoonntt..)) >> Additional Visits

• Click Continue to proceed to the next dialog. • Leave the default sub-visit number. • Click Apply to add the new page to the current visit. • The Casebook Spreadsheet will display an empty CRF icon in the designated patient row

and CRF column. Notice that a new CRF column may have been inserted labeled with both the CRF name and the sub-visit number.

• Click the new CRF icon to open the eCRF, for data entry.






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC ((ccoonntt..)) >> DDeelleettee CCRRFF Deleting a CRF

The Delete CRF function allows users to delete saved data from an eCRF. This is useful if data was entered for the wrong patient, if the incorrect eCRF was selected and completed, or if a new visit page was added to the incorrect visit. Any discrepancies and investigator comments will also be deleted along with the data. When deleting data that has been saved, the system prompts users for a deletion reason.

• From the OC RDC Casebook Spreadsheet, click the eCRF icon for the eCRF you wish to delete.

• Click the Delete CRF icon. The Delete CRF window displays.

• Select the appropriate Change Reason and enter a Change Comment if needed. • Click the Delete button. • Click the Ok button, on the Delete CRF Confirmation window.

• Click the Refresh button, to update the Casebook Spreadsheet,






DDAATTAA EENNTTRRYY IINN OOCC RRDDCC ((ccoonntt..)) >> Investigator Comment Investigator Comment The Investigator Comment tool is used by the investigator site to add clinically pertinent details to a data field. The comment function is not a communication tool and in no way replaces the normal channels of communication such as e-mails, phone calls or site visits. Consult your CRA for guidelines outlining the criteria for adding investigator comments. Adding an Investigator Comment to a data field is useful in explaining why a certain piece of data was entered. This could assist in minimizing the number of manual discrepancies that are created.

Comments should not be added if the issue was already captured in a discrepancy or if a data field can be used to capture the information. Any field containing an Investigator Comment appears in magenta (purple/pink).

• From an open eCRF, navigate to and click on the desired field • Click the Investigator Comment tool.

• If the field already has an investigator comment, the dialog displays the current comment for review or update. Otherwise, the dialog allows you to add an investigator comment.

• Enter comment in the Add Investigator Comment window. • Select an appropriate change reason. • Click OK. • The field will be highlighted in magenta.






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT A discrepancy within OC RDC is defined as “Data that falls outside of an expected range of values or is otherwise 'flagged' during the edit check process”. OC RDC automatically raises a discrepancy to alert users to a possible problem with a response value, or a group of response values. The sponsor builds edit checks into the study database that are executed at various points in the data entry process. A discrepancy can be created automatically by the system or manually by a user with appropriate privileges. Also, discrepancies may be created on a single data field or on a section within an eCRF. System Generated Discrepancy A system generated discrepancy alerts the user that there may be a problem with data that has been captured or is missing from a data field. OC RDC executes some edit checks upon data entry for you to address immediately or route to your CRA. These are known as univariate or simple discrepancies. Other edit checks are executed when a eCRF is saved or after validation of the data occurs. These are know as multivariate or complex discrepancies. Examples why system generated discrepancies may appear:

• If data captured in a data field is not in the correct format or is not part of the acceptable list of values (LOV) for that data field. Examples include incorrect date format, missing data, lab values out of range, etc. These discrepancies will appear as soon as the user tabs off of the field containing incorrect data

• Where data comparisons are made against multiple data fields, such as selecting ‘Other’, but not providing a ‘Specify’. Discrepancies will appear as soon as the page has been saved.

• If there is inconsistent or inaccurate data across multiple data pages, such as cross checking information on the adverse event page against the medication page. Discrepancies will not appear until after a validation process is run either during the nightly automatic validation or by a manual validation by the user.






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> CCoolloorrss Discrepancy Colors There is a color scheme associated with the eCRF icons on the OC RDC Casebook Spreadsheet and with the data fields on an open eCRF when a discrepancy is present. The color scheme indicates the status of the discrepancy and who the discrepancy is actionable to.

If a discrepancy has been created on a section within an eCRF, the discrepancy color displays as a colored bar to the left of the data fields associated with the discrepancy.

• A red icon on the OC RDC Casebook Spreadsheet and a red field or bar on the eCRF indicates the discrepancy requires action by the person logged in or someone else who shares the same role.

• A yellow icon on the OC RDC Casebook Spreadsheet and a yellow eCRF field or bar indicates that the discrepancy is actionable to someone outside of your role.

• A white icon on the OC RDC Casebook Spreadsheet and green field or bar indicates the discrepancy is closed.

Closed discrepancy Actionable

discrepancy

Section discrepancy routed to CRA






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> VVaalliiddaattiioonn Validation Error Window The Validation Error window displays for discrepancies during initial data capture and during subsequent data capture sessions. The Validation Error window is used to view the reason for the discrepancy and to take action. During initial data entry, the Validation Error window displays immediately after a user Tabs off of the data field, or clicks in a checkbox field, if invalid data has been entered.

NOTE: The Validation Error and Reason for Change window will display if you are modifying a value on a saved eCRF and the value is invalid.

1. Reason

2. Error Detail

3. Comments

4. Action Drop-down List

Call-out Definitions:

1. The Reason section will give the user a short version of the discrepancy reason. 2. The Description gives further detail on the reason for the discrepancy. 3. The Comments section should be used if routing the discrepancy to the CRA in order to

provide as much information as possible to the CRA for resolution. 4. The Action drop-down menu will allow you to send to CRA.






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> RReessoolluuttiioonn Discrepancy Resolution During Data Entry

Data modifications or changes often accompany discrepancy resolution. Remember to change all necessary data associated with the discrepancy. When discrepancies occur during the data capture process, a couple of actions can be taken:

1. Correct the data immediately 2. Route the discrepancy to the CRA

Option 1 - Correct the Data Immediately (RECOMMENDED) When the discrepant data is immediately corrected, the discrepancy automatically closes and there is no history of the discrepancy.

• Review the reason for the discrepancy in the Description section of the Validation Error window.

• Click the Cancel button to close the Validation Error window. • Retype or re-select the correct value for the data field. • Press the Tab key to move to the next data field. • The discrepancy is automatically closed.






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> RReessoolluuttiioonn

Option 2 – Route the Discrepancy to the CRA Users are able to route a discrepancy to their CRA, for guidance or instructions on how to address a discrepancy. • Review the reason for the discrepancy in the Description section of the Validation Error

window. • Type in a comment that explains why the discrepancy is being routed. • Click the drop-down arrow in the Action field and Select Send to CRA from the list. • If necessary, select a change reason from the Reason field on the Validation Error and

Reason for Change window. • Click the OK button to close the Validation Error Processing window or the Validation Error

and Reason for Change window. • The eCRF displays and the field containing the routed discrepancy displays in yellow. • Click the Save icon. • Click the OK button. • Click the red X to close the window or navigate to the Previous CRF or Next CRF in this

visit using the buttons in the upper right of the window.

• Click the Refresh button. The eCRF icon on the Casebook Spreadsheet will display in yellow.

Discrepancy Resolution After Data Entry Discrepancies created after data entry are the result of saving the eCRF or validating the data, and are addressed through the CRF Navigator. When discrepancies occur after the data capture process, a couple of actions can be taken:

1. Correct the data immediately 2. Route the discrepancy to the CRA






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> CCRRFF NNaavviiggaattoorr CRF Navigator - Discrepancy Tab The CRF Navigator is a window pane on the right side of an eCRF that contains two tabs, one of which is the Discrepancy Tab. The discrepancy tab lists any discrepancies on the open page allowing the site user the option of resolving or routing the discrepancy.






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> CCRRFF NNaavviiggaattoorr Resolving Discrepancies When resolving discrepancies, if you are making a change to the data it may be a two part process. One, address the open discrepancy, and two, modify the data in the data field or eCRF section.

• From the OC RDC Casebook Spreadsheet, click a red eCRF icon. The eCRF displays. • Click the Open CRF Navigator button to the right of the eCRF to open the CRF Navigator

Pane.






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> CCRRFF NNaavviiggaattoorr

• CLICK on the desired Discrepancy in the List to display the Details below. • GO to data field and enter correct data. • Press the tab key. The Reason for Change window immediately displays. • Select the Reason for changing the data. • Enter appropriate Comment if applicable. • Click the OK button to close the dialog window. • Click the Save icon. • Click the OK button. • Click the red X to close the window or navigate to the Previous CRF or Next CRF in this







DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> CCRRFF NNaavviiggaattoorr Routing Discrepancies

When managing discrepancies, the discrepancy may need to be routed to the CRA for further instruction, guidance, and/or closure.

From the OC RDC Casebook Spreadsheet, click the eCRF cell containing a red icon • From the OC RDC Casebook Spreadsheet, click a red eCRF icon. The eCRF displays. • Click the Open CRF Navigator button to the right of the eCRF to open the CRF Navigator

Pane. • CLICK on the desired Discrepancy in the List to display the Details below.

• Select Send to CRA from the Action drop down list. • Click the Go button. • The Discrepancy Action – Send to CRA dialog window displays.

• Enter a Comment explaining why the discrepancy is being routed. • Click the OK button. (Field(s) will highlight in Yellow)






DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> CCRRFF NNaavviiggaattoorr

• Click the Save icon. • Click the OK button. • Click the red X to close the window or navigate to the Previous CRF or Next CRF in this







DDIISSCCRREEPPAANNCCYY MMAANNAAGGEEMMEENNTT ((ccoonntt..)) >> CCRRFF NNaavviiggaattoorr Viewing Discrepancy History

Once a discrepancy is saved to an eCRF, users are able to view the history of the discrepancy in the CRF Navigator. To view the discrepancy history:

• From the OC RDC Casebook Spreadsheet, click the eCRF icon containing a discrepancy of any status. The eCRF displays.

• Click the CRF Navigator button to the right of the eCRF to expand the CRF Navigator Pane.

• CLICK on the desired Discrepancy in the List, to display the details below. • Click the History button to display the Discrepancy History window.

• When finished viewing the history, click the Close button






OOCC RRDDCC FFeeaattuurreess Viewing Investigator Comment in the CRF Navigator When the CRF Navigator - Investigator Comment tab is selected, all data fields which contain an Investigator comment are listed.

To view a comment: • On an open eCRF, select the Investigator Comment Highlight, from the drop-down list in

the top left corner of the eCRF.

• Any field containing a comment appears in magenta (purple-pink). • Select the investigator comment item from the List or the eCRF. • Details of the Investigator comment will display in the CRF Navigator pane. • Additional information can be reviewed by clicking the History button.






OOCC RRDDCC TTOOOOLLSS ((ccoonntt..)) >> AAuuddiitt HHiissttoorryy Audit History OC RDC automatically keeps a history of any data changes that have occurred for each field after the eCRF has been saved the first time.

The system prompts users to supply a change reason when data is modified on an eCRF that has been saved. The history contains information on who changed the data, the previous value, the date and time the modification occurred and a reason for the change. Any field that has an audit history displays in blue when the Audit History highlight is selected. To view the history of a data field

• On an open eCRF, select the Audit History Highlight, from the drop-down list in the top left corner of the eCRF.

• Any field containing a history displays in blue. • Click the Audit History button at the bottom of the eCRF to expand the Audit History pane.

• In the Audit History pane, information regarding fields with audit history will display.






OOCC RRDDCC TTOOOOLLSS ((ccoonntt..)) >> AAuuddiitt HHiissttoorryy

• A separate Audit History Details window can be viewed, by clicking on the Details button.

CRF Search Criteria

Once data capture has begun for the study, users are able to use search criteria to sub-set or filter data for display. The Search feature in helps you locate specific information from different eCRF pages. On the Casebook and Review tabs, CRF search criteria fall into two sub-categories: 1. CRF Status Criteria Under this category, you select search parameters based on the status of the CRF. The various CRF status parameters are:

• Entry: Select the entry status of the CRF to locate. Your options are- All, Blank, Entry Complete, and Batch Loaded.

• Discrepancy: Select the discrepancy status of the CRF to locate. Your options are - All, Active, Other, Open (Active & Other), Clean (None or Closed). The Clean option is replaced by Closed on the Review tab.

• Approval: Select the approval status of the CRF to locate. Your options are- All, Not Approved, Approved, Awaiting re-approval, and Approval Undone.

• Verification: Select the verification status of the CRF to locate. Your options are- All, Not Verified, Verified, Awaiting re-verification, and Verification Undone.






OOCC RRDDCC TTOOOOLLSS ((ccoonntt..)) >> SSeeaarrcchh CCrriitteerriiaa 2. CRF Source Criteria You can select search parameters based on the source of the CRF. There are three sources from which to locate a CRF.

• Casebook: Select the casebook used at the time of initial data entry into the CRF. Your options are All or individual casebooks in the study, sorted alphabetically in the drop-down selection list. This parameter is useful if patients, whose data was entered using an earlier version of the casebook, are reassigned to a new version of the casebook.

• Visit: Select the number of the visit during which the CRF data was collected. If a casebook is specified, OC RDC displays only the visits defined for the selected casebook in the drop-down selection list. If the casebook selection is All, OC RDC displays all visits defined for the study.

• CRF Name: Select the name of the CRF to review from the drop-down list. This parameter is useful in reviewing all CRFs of a certain type, for example, all Adverse Events forms, or all Concomitant Medications forms.

The Search features allow users to specify the data display in greater detail. This is a useful tool which has the potential of assisting users with their work flow for data capture and discrepancy management.

• Click the Go button to perform the search and retrieve the desired patient data.






OOCC RRDDCC TTOOOOLLSS ((ccoonntt..)) >> SSeeaarrcchh CCrriitteerriiaa • The Casebook or Review tab will update with the desired CRF Search Criteria.






OOCC RRDDCC TTOOOOLLSS ((ccoonntt..)) >> PPaattiieenntt VVaalliiddaattiioonn Patient Validation

Each database has an automatic validation process to run edit checks on a nightly basis. These edit checks are part of the protocol specific database design and ensure that fields within an eCRF and across multiple eCRFs contain data that corresponds appropriately. If data fields contain data outside of the edit check parameters, a discrepancy will be generated by the system.

While these nightly edit checks are helpful, there may be instances when a site user would like to confirm that all data fields are correct as entered without waiting for the nightly validation.

The site user is capable of running a manual patient validation. Patient Validation is a validation on all saved eCRFs in a site. This may include eCRFs that are not part of the current workset. Validating a site allows you to view and manage your discrepancies in real time. If a discrepancy was created by a validation procedure, you must re-validate the data to close/clear the discrepancy. To validate the eCRFs associated with a site

• In the Casebook tab, click the check box next to the appropriate patient icon. • Select Validate from the “Select Patients and…” drop down list.

• Click the Go button. • Click Continue when the Validate Patients window appears. • Read the Confirmation dialog window to confirm successful validation. • Click the Close button.






PPRRIINNCCIIPPAALL IINNVVEESSTTIIGGAATTOORR AAPPPPRROOVVAALL PPRROOCCEESSSS

After all discrepancies have been closed, and all eCRFs have been verified by the CRA, the investigator approval process can proceed. The study team will determine when a casebook is complete and ready for approval. The Principle Investigator and/or their designee are the only site staff who will have this access. The following steps outline the process for approving eCRFs.

• Click the check box next to the patient icon on the Home tab. • Leave the default selection of Open Patient Casebooks in the “Select Patients and…” drop

down list and Click the Go button.

• Click the check box next to the patient icon on the Casebooks tab. • Select Approve from the “Select Patients and…” drop down list. • Click the Go button.

• The Approve CRFs dialog window displays, where you are required to ENTER your username and password and a comment if applicable.

• LEAVE default check marks selected. (in most instances) • CLICK the Continue button.






PPRRIINNCCIIPPAALL IINNVVEESSTTIIGGAATTOORR AAPPPPRROOVVAALL PPRROOCCEESSSS ((ccoonntt..))

• Click Yes when the Approve CRFs warning dialog window appears. • Click the Close button on the Confirmation window. • Approved CRFs will display on the Casebook Spreadsheet with the Approved CRF icon.

Re-Approve or Undo Approval at the eCRF Page Level If a data change occurs on a page due to data being added/modified, or a database modification,

after Investigator Approval, the re-approval icon will appear, and the eCRF will need to be re-approved. I an eCRF was approved in error, the Principal Investigator can un-approve the eCRF.

The Investigator would conduct the following steps re-approve or undo approval of a single eCRF. • Open the eCRF in need of re-approval or un-approval. • Click the Approve icon.






PPRRIINNCCIIPPAALL IINNVVEESSTTIIGGAATTOORR AAPPPPRROOVVAALL PPRROOCCEESSSS ((ccoonntt..))

• CLICK the Re-Approve or Undo Approval button in the Approve CRF window, add a comment if needed.

• Enter username and password in the CRF Approval Signoff dialog window. • Click the OK button. • Click the Close button when the CRF Approval Signoff window appears.






LLOOGGGGIINNGG OOUUTT OOFF OOCC RRDDCC

It is important that any work in an eCRF is saved before attempting to log out. Failure to save work results in the data or changes being lost. Properly logging out ensures that your account session is completely terminated.

To Log out:

• Click the Logout link at the top of the screen. • Close all open windows.






OOCC RRDDCC TTRRAAIINNIINNGG SSUUPPPPOORRTT Training Options & Access Requests OC RDC application training is available for all OC RDC users. Application training covers functionality of OC RDC.

• OC RDC is an eCRF and not a direct data entry system; source documentation is required. • All equipment provided to the site should ONLY be used for OC RDC or other PPD

approved applications. • The PPD EDC Support Center is available 24 hours a day, 5 days a week, with weekend

and holiday pager support. Multilingual translators are available. • The PPD EDC Support Center is for technical questions only. Please contact the CRA for

study protocol or eCRF related questions. • At the end of the study, a CD of all subject data will be provided to the sites - Investigator

confirmation and sign-off is required after receipt of the entire site’s study data on the CD. Until the CD is received, sites must continue to have access to PPD and their OC RDC data.

• All training sessions must be documented before access to a study protocol in the OC RDC application is granted.

Training Materials

The following OC RDC training materials are available for all site users: • On-line training • Quick Reference Guide • Investigator Site User Guide






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Global + 44 (0) 1223 374580 North America + 866-765-0279

World Phone toll free numbers outside the US and Canada can be found at http://edc.ppdi.com/html

http://edc.ppdi.com/

Documents

Investigator Site OC RDC 4.5.3 HTML User Guidestorage.ppdi.com/edc/html/reference/site/4.5.3_Site_User_Guide.pdf · Investigator Site User Guide (OC RDC) ... The Casebook Spreadsheet