Frequently Asked Questions - UCB RDC eLearningucb-rdc-training.c3i-inc.com/Docs/rdc_reference.pdf · Frequently Asked Questions RDC 4.6.6 Quick Reference Guide VERIFICATION 1. What

Frequently Asked Questions

RDC 4.6.6 Quick Reference Guide

ACCESS AND NAVIGATION

1. How do I change my RDC password?

2. What are the guidelines for a new password?

3. What types of information will I get in the “Activities” section on the “Home” tab?

4. I closed RDC by clicking the in the upper-right corner. Is that O.K.?

5. How do I access the RDC Online Help Guide?

6. How do I access supporting documents like the study protocol and Helpdesk contact information?

PATIENT DATA ENTRY

1. What do the different patient icons represent?

2. What do the different CRF symbols mean?

3. What are the shortcuts for entering dates?

4. How do I enter partial dates?

5. How do I delete a CRF page?

6. How do I enter additional adverse events in RDC?

7. How do I indicate that one of the CRFs was not completed during the patient’s visit?

8. Some of the CRF fields and field names are grey. How can I enter data in these fields?

9. All the fields in a CRF are grey. How can I enter data in these fields?

10. How can I quickly see the list of all CRFs for a specific patient?

DISCREPANCY MANAGEMENT

1. Why do some red CRF symbols turn white after I respond to the discrepancy?

2. What is the quickest way to find my active discrepancies?

3. What should I do with yellow CRF symbols?

4. I entered all my data yesterday and all CRF symbols were white. When I logged into RDC today, there were several red CRF symbols. Why?

5. I saw a red CRF symbol and opened the CRF, but I don’t understand what is wrong with the data. How can I find more information about the discrepancy?

INVESTIGATOR COMMENTS

1. What is the quickest way to find a list of CRFs that contain investigator comments?

Frequently Asked Questions


VERIFICATION

1. What is the quickest way to find a list of CRFs that are ready for verification or re-verification?

2. Is it possible to verify more than one CRF page at a time?

3. The Site User made an update to the CRF data after the CRF had been verified. What steps should I take to re-verify the CRF?

4. How can I tell what fields the Site User updated after I verified the CRF?

5. I verified a CRF by mistake. Is there a way to revoke the verification?

REVIEW AND APPROVAL

1. How can I quickly see a list of CRFs that are ready to be approved or re-approved at my site?

2. Why do I need to enter my password each time I approve a CRF?

3. Is it possible to approve more than one CRF page at a time?

4. The Site User made an update to the CRF data after the CRF had been approved. What steps should I take to re-approve the CRF?

5. How can I tell what fields the Site User updated after I approved the CRF?

6. I approved a CRF by mistake. Is there a way to revoke the approval?

REPORTS AND SPECIAL LISTINGS

1. How do I print a new Patient Data Report?

2. How do I print a new Blank Casebook Report?

3. How do I run a report?

4. Why does my report show data from the wrong site?

5. Why doesn’t the Reports Dashboard open?

6. What is the “XML” icon for?

Access and Navigation


CRF STATUSES

In RDC, each CRF is displayed as a symbol, which identifies its status. Please note that combinations of symbols are also possible (e.g., you might see a yellow CD).

Symbol Name Description

Placeholder CRF has not been entered.

Entry Complete CRF has been entered.

Blank CRF has been marked “Blank”.

Actionable Discrepancy

CRF has been entered and has at least one actionable / active discrepancy. The currently logged in user, or another user belonging to the same group, should address it.

Other Discrepancy CRF has been entered and has at least one

other discrepancy. Note that even if a symbol is white, there may be a hidden discrepancy on the CRF. A user from a user group other than the one currently logged in has to address it.

Verified CRF is source data verified.

Re-verification Required

CRF requires re-verification. At least one data point was modified after verification of the CRF (but before approval).

Approved CRF was approved by the Investigator

Re-verification and Re-approval Required

CRF requires re-verification and re-approval. At least one data point was modified since approval of the CRF so it must be re-verified and then re-approved.

Re-approval Required CRF requires re-approval.

Locked The CRF has been verified, approved and

locked. To make a change, contact your CRA.

Batch Loaded External data have been loaded, e.g., lab data.



ACCESSING RDC

1. Open the “UCB Extranet for RDC” web page (https://insite.ucb.com/rdc). • Note that if you are a Reviewer or Data Manager

who logs into RDC from a computer that is already connected to the UCB network, you will not need to log into “UCB Extranet for RDC”. You will be able to access the RDC Login page directly. Skip to step 4.

2. Enter your “UCB Network Account” and “Password”.

3. Click . • The “RDC Login” page is displayed.

4. Enter your “User Name” and “Password”.

5. Click .

NAVIGATION AND TERMINOLOGY

RDC tabs: • Home: is displayed by default. It is the

portal for RDC Activities, News and general information. In addition, from this tab, you can begin and/or access patient casebooks and perform searches for patients and CRFs.

• Casebooks: is where you will find the Case Report Forms (CRFs) for each patient grouped by casebook and visit. It is the only tab from which data entry can be initiated for a CRF. At UCB, every patient has typically only one casebook assigned.

• Review: is where you can search for CRFs with discrepancies or investigator comments. In addition, you can quickly browse and review the data that is medically coded with either WHO-DRL or MedDRA (e.g. the data in the modules Concomitant Medications, Medical History or Adverse Events).

• Reports: lists the reports you have run and you can create blank casebook reports and patient data reports.

Elements of the “Home” tab: • Session Time: In the top

right corner of the screen, the small box lying on top of the RDC application shows the time left in hours for the current session in RDC. A session is a maximum of 8 hours long, after which you have to login again. However, please be aware that your session will be disconnected if it is idle for more than one hour.

• Current Session: The currently logged in user is listed together with the date and time of the last refresh of the RDC data on the screen.



• Study and Site section: RDC only displays data for one study and site at a time. To change to a different study and/or site, select them from the drop-down lists in the top right corner of the “Home” tab. To see a summary report for the study and site currently selected, click the “Study and Site Summary” link below the drop-downs.

• “News” section: contains links to alerts about upcoming system down-time, as well as study-specific information and supporting documents and Helpdesk contact information.

• “Activities” section: is where you will find links to the most common activities performed in RDC. The links that are displayed depend on your responsibilities, the data in the system and the activities that can be performed on that data.

• “Links” section: contains links to related Internet addresses which are added by UCB as well as a “Reporting” link which is used to generate a Report. Clicking a link in this section opens a new browser window.

• “Patients” list: contains all patient numbers assigned to your site. Each patient has a patient icon, which represents the status of the patient in terms of data entry.

Patient icons:

Patient icon

Description

The patient number has not yet been used. CRFs have not been entered for the patient.

One or more CRFs have been started for the patient.

The patient has at least one actionable/active discrepancy in one or more CRFs. The discrepancy must be addressed by you or someone in your user group.

The patient has at least one other discrepancy in one or more CRFs. The discrepancy must be addressed by someone in a different user group.



CHANGING YOUR RDC PASSWORD

To ensure the security of your RDC account, you are required to change your RDC password every 90 days. Also, if at any time while working in RDC you feel your password has been compromised, you can change it. To change your RDC password: 1. From the “Home” tab, click the “Change Password” link. 2. Enter your “Old Password” and your “New Password”. 3. Enter your new password again in the “Confirm Password” field.

4. Click . Passwords must: • Be at least 8 Latin characters long • Include upper and lower case Latin characters • Include at least 1 number • Not be a previous password • Not have 5 occurrences of the same character

ACCESSING RDC ONLINE HELP GUIDE

1. In the upper-right area of the screen, click the “Help” link.

2. To see a list of topics in the guide, click the “Table Of Contents” icon. 3. To expand the topics, click a book icon.

4. To display the contents of a page, click a page icon

5. To close the online Help Guide, click the [Close] button in the upper-right corner of the window.

EXITING RDC

1. In the upper-right area of the screen, click the “Logout” link. • The RDC Logout page displays.

2. If you had connected to RDC through the UCB Extranet, sign off of the Extranet by clicking the [Sign Out] button in the upper-right corner of the window. • Note that if you had not connected to RDC through the Extranet, you would close

your browser window. 3. When the message displays that you successfully logged out of the Extranet, close

Internet Explorer.

Patient Data Entry


ENTERING DATA FOR A NEW PATIENT

1. In the “Patients” list on the “Home” tab, click the checkbox next to the symbol of an

unassigned patient .

2. Click next to “Open Patient Casebooks”. • The “Casebooks” tab is displayed with the CRFs for the first visit in the Casebook

Spreadsheet. OR

1. Click the “Casebooks” tab. 2. Perform a search for all unassigned patient numbers:

• From the “Show” drop-down in the “Search” section, select “Patients with no data entered”.

• Click in the bottom-right corner of the “Search” section.

• The CRFs for the first visit of the patients are displayed in the Casebook Spreadsheet.

ENTERING DATA FOR EXISTING PATIENTS

1. In the “Patients” list on the “Home” tab, click the checkbox next to the patient symbol you want to open.

2. Click next to “Open Patient Casebooks”. • The “Casebooks” tab is displayed with the CRFs for the first visit in the Casebook

Spreadsheet.

3. From the “Visit” drop-down , select the visit that contains the CRFs you want to complete.

4. Click the applicable CRF symbol for the patient. OR

1. Click the “Casebooks” tab.

2. Click in the “Search” section without entering any criteria in the Search fields. • The CRFs for the first visit of the patients are displayed in the Casebook

Spreadsheet.


4. Click the applicable CRF symbol for the patient. OR 1. Click the “Casebooks” tab.

2. In the “Range” field in the “Search” section, enter the patient number.

3. Click in the “Search” section. • The CRFs for the first visit of the patients are displayed in the Casebook

Spreadsheet.

Patient Data Entry



5. Click the applicable CRF symbol for the patient.

ENTERING DATA IN CRFS

1. To open and complete any CRF, click the “Placeholder” symbol in the appropriate CRF name column. • The CRF opens in a new window. An example of a CRF is shown below:

2. If necessary, scroll down using the scroll bar on the right side of the page to see more of

the CRF. 3. When there is more than one page in a CRF, you will see a tab in the top right corner of

the page with the page number. You will also see the page count and navigation icons on the toolbar (circled above). Click the icons to go back and forth between pages.

4. Complete the fields (see Field Types on the next page for instructions on completing the types of fields found in CRFs). • You can move to another field by pressing the TAB key on your computer or clicking

in the field. 5. Scroll down to the bottom of the page to make sure you fill in all fields. 6. Once the CRF is complete, click the [Save] icon on the CRF toolbar.

• Note that, when a CRF is saved, plausibility checks are run that might create discrepancies for the entered page. If you click the “Next CRF” link or the [Close] button , you will not know if any discrepancies were generated until the CRF is closed. Therefore, we recommend that you save the CRF using the [Save] icon , and then go to the next CRF or close the CRF.

Patient Data Entry


7. After saving the CRF, you have three options: • “Next CRF” link: Opens the next CRF of the visit. • [Close] button : Closes the CRF. • “Previous CRF” link: Opens the previous CRF of the visit is applicable.

8. After you close the CRF, the “Casebooks” tab is displayed.

• The CRF symbol changes to the “Entry Complete” symbol .

• The patient symbol changes to .

FIELD TYPES

Date field: • For all date fields, you can type the date directly

in the field, e.g. enter 300614 for 30-JUN-2014 OR Select the date from a calendar by clicking the [calendar] symbol next to the field (the icon only appears when the cursor is in the field) OR Use one of the following shortcuts: • T = today’s date • Y = yesterday’s date • L = last date entered

• Sometimes it is not possible to record a full date, especially in the “Medical History” CRF. Therefore, RDC can record partial dates. • If only the year is known, enter the 4-digit year (format YYYY), e.g. 2006. • If only the month and year is known, enter the 2-digit month and 2-digit year

(format MMYY), e.g. 0506. RDC will display it e.g. as MAY-2006. • Please do not enter a combination such as “UNK-2006” as it will cause a

discrepancy. List Of Values (LOV) field:

• An LOV field is a field in which pre-determined values must be entered.

• Click in the field and a [magnifying glass] symbol appears on the right. The icon only appears when the cursor is in the field.

• To complete this type of field, you can type the value OR Select it from a list of values using the [magnifying glass] symbol .

• Click the [magnifying glass] symbol . A dialog box is displayed with the list of values that can be inserted in this field.

• The “Value” column indicates the accepted values. • To select a value, click the radio button in the

“Select” column of the desired row in the dialog box.

• Click to insert the selected value.

Patient Data Entry


Checkbox field: • The “Was a blood sample taken?” field is an example of a checkbox field. • Clicking in this type of field adds an X, or tick. • Clicking again removes the mark.

Free-text field: • A free-text field is a field in which you must enter the

information directly in the field. Conditional field:

• In some CRFs, you may find that completing a field triggers additional fields to become active in that same CRF. These new fields are referred to as conditional fields; their availability depends on how another field in the same CRF is completed.

• Conditional fields are shaded in gray when they are not active.

• For example, in the CRF to the right, selecting Female would trigger the next two fields to become active and they would no longer be shaded in gray.

• Sometimes gray fields indicate that the entire CRF or one more sections of the CRF have been marked as Blank. To learn how to un-blank the CRF or section(s), review the Entering Data For Existing Patients section in this Quick Reference Guide.

EDITING EXISTING CRF DATA

1. Open the CRF. • For more information about locating and opening CRFs, review the

Entering Data For Existing Patients section in this Quick Reference Guide. 2. Identify the field in the CRF that requires a data change and make that change.

3. Click the [Save] icon . • The “Reason for Change” dialog box is

displayed. 4. From the “Reason” drop-down, select the

applicable reason. • The “Comment” field is optional.

5. Click to save the reason.

6. Click in the “Saved” dialog box.

7. Click the [Close] button to close the CRF. • The “Casebooks” tab is displayed again.

Patient Data Entry


PRINTING CRFS

You can print a copy of single CRFs for your records. For more information about printing a whole CRF book or multiple CRFs, review the Generating a Patient Data Report section in this Quick Reference Guide. To print a CRF: 1. Open the CRF.

• For more information about locating and opening CRFs, review the Entering Data For Existing Patients section in this Quick Reference Guide.

2. Click the [Print] icon located on the CRF toolbar. • The “Print” dialog box is displayed.

3. Click .

REVIEWING AUDIT HISTORY

Every change that you make to a field in a saved CRF is tracked in the audit history. The “Audit History” pane enables you to easily see which fields have changed over the life of the CRF (the Audit History). To review audit history: 1. On the CRF toolbar, click the “Highlight” drop-down and select “Audit History”.

• All fields in the CRF page that have been changed since they were originally entered are now shaded in blue.

2. You can review the changes made to a specific field in the “Audit History” pane. There are two ways to open this “Audit History” pane: • Click in a blue shaded field and then click the [up arrow] near the bottom of

the screen. OR • Right-click in a blue shaded field and select “Show Audit History” from the context

menu that opens. 3. The “Audit History” pane

opens at the bottom of the screen with details about all changes that have been made in the specific field since the CRF was first saved. You can see the old and new values as well as by whom and when it was changed.

4. To close the “Audit History” pane, click the [down arrow] at the top edge of the pane.

Patient Data Entry


ADDING A SUPPLEMENTAL PAGE

Sometimes it becomes necessary to insert additional CRF pages for a patient, e.g., for additional AE pages or unscheduled visits. Note that the first Adverse Event for a patient is added under the ANNEX visit. All additional adverse events are entered under the ADD AE visit. Unscheduled exams are recorded under the UNSCHEDULED visit. To add a supplemental page for an adverse event: 1. From the “Casebooks” tab, search for the patient.

• For more information about searching for patients, review the Entering Data For Existing Patients section in this Quick Reference Guide.

2. From the “Visit” drop-down , select “ADD AE”. 3. Select the patient by clicking the checkbox in the “Select” column next to the patient’s

symbol.

4. Click . • The “Add Visit Page” dialog box is

displayed. The AE X CRF is selected.

5. Click above the CRF name. 6. You are then prompted to select a “Sub-

visit”, which defaults to 1. Note that additional pages that you might create later will have the number defaulted to 2, 3, 4.... To accept the default of “Sub-visit” 1, click at the bottom of the dialog box. • A new AE X CRF is added in the spreadsheet with a “U” next to the symbol indicating

the CRF is unplanned. The name of the CRF ends with .1, indicating the Sub-Visit. To open this new supplemental page, click the CRF symbol.

• You must complete the CRF before navigating away from this screen. If you do not complete it, the CRF symbol will be removed and you will have to add it again.

• All subsequent adverse events for this patient would now be added by selecting the patient and clicking .

BLANKING AND UN-BLANKING CRFS

Sometimes certain assessments foreseen by the study protocol are not applicable and therefore not performed for a patient. RDC offers the option to mark a CRF page as blank and therefore state that the page was “intentionally left blank”. It is possible to either mark the complete page or parts (sections) of the page as blank. The blank sections will be colored in grey and no data entry is possible. To blank a CRF: 1. Open the CRF.

• For more information about searching for patients and opening CRFs, review the Entering Data For Existing Patients section in this Quick Reference Guide.

Patient Data Entry


2. There are two ways to blank a CRF: • The “Blank?” checkbox: Located in the header of every CRF, clicking this

checkbox blanks all fields in the entire CRF so that data cannot be added. OR The “Blank Flag Tool” icon : Located on the CRF toolbar, clicking this icon opens the “CRF Blank Selection(s) Processing” dialog box. • To blank the entire CRF, click the “Mark

this CRF as having no responses” checkbox. Click to confirm your selections.

• To blank a specific section, click the checkbox for that section. Click to confirm your selections.

3. All editable fields in the sections you selected are now shaded and data can no longer be added to those fields. • If you did not select a section, those fields are still editable. Note that you must

complete the remaining sections before you save and close this CRF. If you do not do so, the entire page will be marked blank.

4. Click the [Save] icon .

5. Click .


• If the entire CRF is blank, the symbol changes to the “Blank” symbol . If you mark a CRF blank, you can un-blank it at a later time. Un-blanking allows you to add data to the fields in a CRF previously marked blank. To un-blank a CRF: 1. Open the CRF.


• The fields are shaded grey and the “Blank?” checkbox in the header is ticked. 2. There are two ways to un-blank a CRF:

• The “Blank?” checkbox: Click in this checkbox to un-blank the CRF. OR The “Blank Flag Tool” icon: Located on the CRF toolbar, clicking this icon opens the “CRF Blank Selection(s) Processing” dialog box. • To un-blank the entire CRF, click to

remove the tick from the “Mark this CRF as having no responses” checkbox. Click

to confirm your selections. • To un-blank a specific section, click to

remove the tick from the checkbox for that section. Click to confirm your selections.

Patient Data Entry


3. Since you are editing a CRF that was previously opened and saved, the “Reason for Change” dialog box is displayed.

4. Click the “Reason” drop-down and select the reason you made the change. • The “Comment” field is optional.

5. Click the button. • The fields that were shaded are now white again. If you do not enter any data before

saving the CRF, the CRF will revert back to blank again. You must enter the data at the same time you un-blank the CRF.


7. Click .


• The CRF symbol changes to the “Entry Complete” symbol .

DELETING ALL DATA IN A CRF / DELETING A CRF

Sometimes it becomes necessary to delete a CRF page, e.g., if the data has accidentally been entered for an incorrect patient number. When you delete a CRF, you delete the data in the CRF. A record of the deleted page remains in the audit trail. A new empty CRF takes its place so it can be completed for the patient. To delete all data in a CRF: 1. Open the CRF.


2. Click the [Delete] icon on the CRF toolbar. • The “Delete CRF” dialog box is displayed.

3. From the “Change Reason” drop-down, select the reason for this change. The “Change Comment” field is optional.

4. Click to confirm the change.

5. In the confirmation dialog box, click . • The CRF automatically closes and the

“Casebooks” tab is displayed.

• The symbol changes to the “Placeholder” symbol , enabling you to enter new data into the CRF.

Discrepancy Management


IDENTIFYING THE TYPES OF DISCREPANCIES

RDC creates a “Discrepancy” to indicate that the entered data does not match the plausibility criteria defined for the study. Sometimes discrepancies can be worked on immediately. Other times, they may need to be routed to a CRA or the site for review, or routed to the Data Manager to be closed. Only Data Managers can close discrepancies that are not addressed via data correction by the site. Types of discrepancies:

Symbol Name Description

Actionable/Active Discrepancies that the currently logged in user (or

another user belonging to the same group) should solve. Actionable discrepancies can be identified by the red CRF symbol and red fields in the CRF.

Other Discrepancies that a user from a different user group

than the one currently logged in have to solve. Other discrepancies can be identified by the yellow CRF symbol and yellow fields in the CRF. Note that if a CRF contains an actionable and other discrepancy, the CRF symbol is displayed in red.

The goal of Discrepancy Management is to have a white CRF page that can be verified, approved and locked. To achieve this…

• Enter “clean” data into the CRF. • Update the discrepant data to fulfill the plausibility criteria. A discrepancy that is

automatically closed due to an update of data is displayed in white on the CRF page. • Send the discrepancy to a different user group so it can be resolved by them. • Send the discrepancy to the Data Manager to close / resolve. Once it is closed, the

discrepant field will turn white. • Code and approve the medical terms using MedDRA and WHO-DRL (to be done by

Coding Managers).

CREATING A DISCREPANCY

If you notice a problem with the data entered into RDC and are not able to change the data yourself, you can create a discrepancy and route it to a different user group in RDC. Site Users, Investigators, CRAs, Data Reviewers, Data Managers and users with a Limited Review role may create discrepancies. To create a discrepancy: 1. Open the CRF.




2. Locate the field that requires a discrepancy. 3. There are two ways to add a discrepancy. You can:

• Click in the field and then click the [Add Discrepancy] icon on the toolbar. • Right-click in the field and select “Add Discrepancy” from the menu that opens.

4. The “Add Discrepancy” dialog box is displayed. • Select “Field Discrepancy” to attach the

discrepancy to the respective field/question, or “Section Discrepancy” to attach the discrepancy to the module (section)

• The “Reason” field defaults to “Data Entry Comment,” but can be changed as appropriate.

• In the “Description” field, enter a description about the discrepancy.

• The “Comment” field is optional. 5. To route the discrepancy to the site user, click the “Action” drop-down.

• Select “Personal / Group Reminder” to create a note for your own user group as a reminder.

• Select any of the remaining options to send the discrepancy to the respective user group.

6. To save your entries, click . • The data in the CRF field remains, but the field is now highlighted in yellow. • If the field does not contain a yellow highlight, review the steps in the

Highlighting Discrepancies in a CRF section in order to display the yellow highlight.

• The yellow color indicates this is now an “other” discrepancy and must be addressed by a person in another user group.

• Note that if you had selected “Personal / Group Reminder”, the field would have turned red since someone in your own user group would be responsible for the discrepancy.

7. To close the CRF, click the [Close] button . • The “Save Edits?” dialog box is displayed since you made a change to the saved CRF

(you created a discrepancy).

8. Click . • After you close the CRF, the “Casebooks” tab is displayed.

• The CRF symbol changes to the “Other Discrepancy” symbol .

• The patient icon changes to . • A person in another user group besides your own is responsible for resolving the

error. When someone in the other user group opens this patient’s casebook, he/she will see a red patient icon and CRF symbol, meaning there is an “actionable” discrepancy that he/she must address.



RESPONDING TO AND FIXING A DISCREPANCY THAT OCCURS WHEN DATA ARE ENTERED

Sometimes when you enter data in a CRF, a discrepancy is generated immediately and you can take action to fix it at that time, if appropriate. Only the Site Users and Investigator at the site can close a discrepancy by updating the data entered into RDC. To respond to and fix a discrepancy that occurs when data are entered: 1. When you enter data that does not fulfill the plausibility criteria, a discrepancy is

immediately created. • The “Validation Error” dialog box opens.

2. Read the “Reason” and “Description” fields to identify why the validation error occurred.

3. Click to close the dialog box. 4. Enter the correct value in the field that had

the discrepancy.


6. Click .


• The CRF symbol indicates that data have been entered and there are no discrepancies.

RESPONDING TO AND FIXING A DISCREPANCY THAT OCCURS WHEN A CRF IS SAVED

Some discrepancies are generated after you finish entering data and save the CRF page. In those instances, the field(s) with the discrepancy turn red after the page is saved. Only the Site Users and Investigator at the site can close a discrepancy by updating the data entered into RDC.

To respond to and fix a discrepancy that occurs when a CRF is saved:

1. After entering data, click the [Save] icon .

2. Click . • The field immediately becomes red, indicating there is a

discrepancy. 3. To learn why this field has been flagged as invalid, click the

[left arrow] next to the vertical scroll bar to open the “CRF Navigator” pane. • The “CRF Navigator” pane is displayed on the right side of

the screen. • There are two tabs at the top. The “Discrepancy” tab is

displayed by default.



• The “List” section contains a list of the discrepancies in this CRF. RDC distinguishes between two types of discrepancies: • Univariate: Created when the plausibility criteria on one field are violated, e.g.

the upper bound for height [m] is 2.10. Univariate discrepancies are displayed with their label.

• Multivariate: Created when at least one of multiple data fields violates the plausibility criteria for the study, e.g. the field “Pregnancy test performed” is only expected to be answered “yes” for female subjects. Multivariate discrepancies are displayed as “Multi.”

4. In the “List” section, click the red circle or the name. • Selecting a discrepancy in the “List” section displays information about it in the

“Details” section. 5. Based on the information in the “Details” section and the data in the source, update the

CRF data to resolve the discrepancy.


7. Click . • The fields are white again, indicating the data are now valid. • The discrepancy is no longer listed in the “CRF Navigator” pane.



SEARCHING FOR DISCREPANCIES

You can easily find both “actionable” and “other” discrepancies for your site from the “Home” tab. To search for “Actionable/Active” discrepancies: 1. On the “Home” tab, in the “Activities” section, click the “Show # Active Discrepancies”.

(The number in the link depends on the number of “actionable” discrepancies.) • The “Discrepancies” page of the “Review” tab is displayed, with a list of the CRFs

that have a discrepancy to be addressed by you. The CRF symbols are red. To search for “Other” discrepancies: 1. On the “Home” tab, in the “Activities” section, click the “Show #Other Discrepancies”.

(The number in the link depends on the number of “other” discrepancies.) • The “Discrepancies” page of the “Review” tab is displayed. • The CRF symbols are yellow indicating there are “other” discrepancies. Note that if a

CRF also contains an “actionable” discrepancy, the CRF symbol would be red.



HIGHLIGHTING DISCREPANCIES IN A CRF

You can use the “Highlight” drop-down on the toolbar to display fields with discrepancies. To highlight discrepancies in a CRF: 1. Open the CRF.


2. From the “Highlight” drop-down on the toolbar, select “Active and Other Discrepancies”. • Fields with “actionable/active” discrepancies will display a red highlight. • Fields with “other” discrepancies will display a yellow highlight. • Fields with discrepancies that have been resolved will display a green highlight.

ROUTING A DISCREPANCY FOR REVIEW BY ANOTHER GROUP

If a discrepancy cannot be closed by updating the entered data to fulfill the plausibility criteria, e.g. because the problem provided in the description is not clear or the entered data is correct per the source, the discrepancy can be sent / routed to a different user group in RDC. To route a discrepancy for review by another group: 1. When you enter data that does not fulfill the plausibility criteria, a discrepancy is

immediately created. • The “Validation Error” dialog box

opens. 2. Read the “Reason” and “Description”

fields to identify why the validation error occurred.

3. If you cannot update the entered data to fulfill the plausibility criteria, enter a note in the “Comment” field, e.g. “weight correct per source”.

4. From the “Action” drop-down, select the group that should address the discrepancy. • If you are editing the data in a previously-saved CRF, you will also have to indicate

the “Reason” you are editing the data.

5. To save the “Comment” and “Action”, click .


7. Click .


• The CRF symbol indicates that this is now an “other” discrepancy that must be addressed by a person in another user group.



ROUTING A DISCREPANCY FOR CLOSURE

Any RDC user (except the Read Only role) can create discrepancies in RDC. Especially during the Source Data Verification, it often becomes necessary to create a manual discrepancy to document a difference between the source and the data entered in RDC. When a manual discrepancy is created, the CRF symbols become red for the user group responsible for addressing it, indicating it contains an “actionable” or “active” discrepancy. After responding, the discrepancy must be routed to the Data Manager to be closed. Only Data Managers can close discrepancies. To route a discrepancy for closure: 1. Open the CRF that has the “actionable” discrepancy.

• For more information about locating and opening CRFs, review the Searching For Discrepancies section in this Quick Reference Guide.

2. To learn more about the discrepancy for this CRF, click the [left arrow] next to the vertical scroll bar to open the “CRF Navigator” pane. • The “CRF Navigator” pane is displayed on the right

side of the screen. • There are two tabs at the top. The “Discrepancy”

tab is displayed by default. • The “List” section contains a list of the

discrepancies in this CRF. RDC distinguishes between two types of discrepancies: • Univariate: Created when the plausibility criteria

on one field are violated, e.g. the upper bound for height [m] is 2.10. Univariate discrepancies are displayed with their label.


3. In the “List” section, click the red circle or the name. • Selecting a discrepancy in the “List” section displays information about it in the

“Details” section. 4. Based on the information in the “Details” section,

update the CRF data to address the discrepancy. • Since you are changing a field in a saved CRF,

the “Reason for Change” dialog box displays. 5. The “Reason” field defaults to “Data Entry Error”,

but can be changed as appropriate.

6. Click to confirm the reason for the change. 7. From the “Action” drop-down, select “Send to Data Mgt to close”.



8. Click . • The “Discrepancy Action” dialog box displays.

9. To route the discrepancy to be closed, enter a note in the “Comment” field.

10. Click . • The discrepancy color changes to yellow,

indicating that this discrepancy has been routed to the Data Manager to close.


12. Click .


• The CRF symbol indicates there is a discrepancy for another user group to address.

RESPONDING TO AND ROUTING A DISCREPANCY THAT OCCURS WHEN REPORTING A SERIOUS ADVERSE EVENT

When you report a Serious Adverse Event (SAE) in RDC, a discrepancy is automatically generated to remind you to fax the necessary documentation to UCB. After the documents have been sent, the discrepancy can be closed. To respond to and route a discrepancy that occurs when reporting an SAE:

1. After indicating that the patient had a “Serious Adverse Event”, click the [Save] icon .

2. Click . • The “Adverse Event” and “Serious Adverse Event?” fields immediately become red

indicating there is a discrepancy to be addressed by you. • At the same time, an email is sent to study team members to inform them about the

new SAE. UCB internal study team members as well as members of the Drug Safety department can subscribe to this email on a study by study level. To subscribe, please contact the Data Manager responsible for the study.

3. To view the details about the discrepancy, click the

[left arrow] next to the vertical scroll bar to open the “CRF Navigator” pane. • The “CRF Navigator” pane is displayed.

4. Click the red circle or the word “Multi” in the “List” section. • In the “Details” section, the “Description” reminds you to

provide the documentation to UCB. • After faxing the document, you need to route the

discrepancy to the Data Manager to close it. 5. From the “Action” drop-down, select “Send to Data Mgt to close”.



6. Click . • The “Discrepancy Action” dialog box displays.

7. To route the discrepancy to be closed, enter a note like e.g. “done” in the “Comment” field.

8. Click . • The discrepancy color changes to yellow,

indicating that this discrepancy has been routed to the Data Manager to close.


10. Click .


• The CRF symbol indicates there is a discrepancy for another user group to address.

CLOSING A DISCREPANCY

Data Managers are responsible for closing discrepancies that have been addressed, but not closed, via data correction by the site. To close a discrepancy: 1. Open the CRF that has the “actionable” discrepancy.

• For more information about locating and opening CRFs, review the Searching For Discrepancies section in this Quick Reference Guide.

2. To learn more about the discrepancy for this CRF, click the [left arrow] next to the vertical scroll bar to open the “CRF Navigator” pane. • The “CRF Navigator” pane is displayed on the right side of

the screen. • There are two tabs at the top. The “Discrepancy” tab is

displayed by default. • The “List” section contains a list of the discrepancies in this

CRF. RDC distinguishes between two types of discrepancies: • Univariate: Created when the plausibility criteria on one

field are violated, e.g. the upper bound for height [m] is 2.10. Univariate discrepancies are displayed with their label.




3. In the “List” section, click the red circle. • Selecting a discrepancy in the “List” section displays information about it in the

“Details” section. • After reviewing the description and the comment provided, you decide to close this

discrepancy. 4. From the “Action” drop-down, select “Closed (resolved)”.

• In case the comment that the user provided does not have enough detail to justify the closure of the discrepancy or does not address the issue described appropriately, you would send the discrepancy back to the user by selecting “Send to Investigator / Site” from the “Action” drop-down.

5. Click . • The “Discrepancy Action” dialog box is displayed.

6. When closing a discrepancy, you must click the “Resolution Reason” drop-down and select a reason. • The “Resolution Comment” is optional. • Note that if you decide to send a discrepancy

back to the user, you need to provide a detailed comment outlining why the discrepancy cannot be closed.

7. Click to save the reason. • The field that had the discrepancy is now

white. The discrepancy item in the “List” section now has a green circle next to it. The discrepancy has been successfully closed.

8. To close the “CRF Navigator” pane, click the [right arrow] on the edge of the pane. • Note that you can leave the “CRF Navigator” pane open even when you close the

CRF. It will then be visible for the next CRF you open.


10. Click .



Investigator Comments


CREATING AN INVESTIGATOR COMMENT

Investigator comments can be added to CRFs to provide additional information about a field or a page. They should not be confused with comments regarding discrepancies. Comments can only be added to CRFs by Site Users and Investigators. However, CRAs, Data Managers, Reviewers and users with a Limited Review role can review them. To create an investigator comment: 1. Open the CRF.


2. Locate the field that requires an investigator comment. 3. There are two ways to add an investigator comment. You can:

• Click in the field and then click the [Investigator Comment] icon on the toolbar OR

• Right-click in the field and select “Investigator Comment” from the menu that opens. • The “Add Investigator Comment” dialog box is

displayed. 4. Enter the comment in the “Investigator

Comment” field.

5. To save the comment, click in the dialog box. • The data in the CRF field remains, but the

field is now highlighted in purple. • If the field does not contain a purple highlight, review the steps in the

Reviewing Investigator Comments section in order to display the purple highlight.


7. Click .

8. Click the [Close] button to close the CRF. • Note that the CRF symbol does not indicate that investigator comments are entered

on the CRF page.

REVIEWING INVESTIGATOR COMMENTS

Comments can only be added to CRFs by Site Users and Investigators. However, CRAs, Data Managers, Reviewers and users with a Limited Review role can review them. To search for investigator comments: You can easily find investigator comments for your site from the “Home” tab. 1. On the “Home” tab, in the “Activities” section, click the “Review # Investigator

Comments” (The number depends on the number of investigator comments). • The “Review” tab opens with a list of all CRFs for the study that contain investigator

comments.

Investigator Comments


To review investigator comments: There are two places where you can read the comment. The first is on the “Review” tab, in the “Investigator Comments” column. The second is in the CRF itself. 1. Open the CRF. 2. Click the “Highlight” drop-down on the toolbar and select “Investigator Comments”.

• Fields with investigator comments will display a purple highlight.

3. To learn more about the investigator comments for this CRF, click the [left arrow] next to the vertical scroll bar to open the “CRF Navigator” pane. • The “CRF Navigator” pane is displayed on the right side

of the screen. • There are two tabs at the top - “Discrepancy” and

“Investigator Comment”. 4. Click the “Investigator Comment” tab.

• The “List” section contains a list of the fields with an investigator comment entered.

5. In the “List” section, click the purple circle or the name. • Selecting a field in the list displays the investigator

comment in the “Details” section. This is the same comment you saw on the “Review” tab before you opened the CRF.

6. Close the “CRF Navigator” pane by clicking the

[right arrow] on the left edge of the pane. • Note that in your own RDC, you can leave the “CRF Navigator” pane open even when

you close the CRF. It will then be visible for the next CRF you open.

7. Click the [Close] button to close the CRF and to display the “Review” tab again.

Verification


SEARCHING FOR CRFS READY FOR VERIFICATION

You can easily find both CRFs ready for initial verification and CRFs ready for re-verification for your site from the “Home” tab. To search for CRFs ready for initial verification: 1. On the “Home” tab, in the “Activities” section, click the “Review non-blank CRFs ready

for initial Verification” link or the “Review blank CRFs ready for initial Verification” link. • The “CRFs” page of the “Review” tab is displayed, with a list of the CRFs that have

CRFs ready for initial verification. To search for CRFs ready for re-verification: 1. On the “Home” tab, in the “Activities” section, click the “Review non-blank CRFs ready

for Re-Verification” link. • The “CRFs” page of the “Review” tab is displayed, with a list of the CRFs that have

CRFs ready for re-verification.

VERIFYING A SINGLE CRF

1. Open the CRF. • For more information about locating and opening CRFs ready for verification, review

the Searching for CRFs Ready for Verification section in this Quick Reference Guide.

2. Once you have finished reviewing and comparing the data against the source, click the [Verify] icon on the toolbar. • The “Verify CRF” dialog box is

displayed. • You can include an optional

note about the verification in the “Verification Comment” field.

• To retain this comment for use in subsequent CRF verifications during this session (until you log out of RDC), you can click the “Remember comment for subsequent…” checkbox.

3. Click .

4. Click the [Close] button to close the CRF. • Note that you do not need to save the CRF since the data were not changed. • The “Review” tab is displayed again.

• The CRF symbol has a checkmark on it, indicating it was verified. The CRF is now ready to be approved by the Investigator.

Verification


VERIFYING MULTIPLE CRFS SIMULTANEOUSLY

In addition to verifying individual CRFs, you can also verify multiple CRFs simultaneously. UCB requires that the CRA opens and reviews every single page prior to performing the Multi-Page Verification. Therefore, we recommend you only perform Multi-Page Verification on a patient and visit basis. To verify multiple CRFs simultaneously: 1. Search for CRFs ready for verification.

• For more information about locating and opening CRFs ready for verification, review the Searching for CRFs Ready for Verification section in this Quick Reference Guide.

2. On the “CRFs” page of the “Review” tab, locate the CRFs you want to verify. 3. Open and review each CRF, then close the CRFs.

• The “Review” tab is displayed. 4. In the “Select” column, click the checkbox next to each CRF that you want to verify.

• Note that you could use the “Select All” link to select all of the CRFs on the “Review” tab, if the CRFs pertain to one visit for one patient.

5. The “Select CRFs and…” drop-down shows “Verify”. Click . • The “Verify CRFs” dialog box is

displayed. • The “Comment” field is optional.

6. Click to verify that the data in the pages have been entered according to the source.

7. On the warning page, click to continue.

8. Click on the confirmation page. • The “Review” tab is displayed.

• The CRF symbols have a checkmark on them, indicating they have been verified.

RE-VERIFYING A CRF

If any data updates are made to a CRF after it has been verified, RDC automatically requests a re-verification.

If the CRF has not yet been approved, the symbol will look like:

If the CRF had already been approved as well, the symbol will look like:

Verification


To re-verify a CRF: 1. On the “Home” tab, in the “Activities” section, click the “Review non-blank CRFs ready

for Re-Verification” link. The “Review” page is displayed with a list of the CRFs that are ready for re-

verification. 2. Open a CRF and review any changes made since the initial verification.

For more information about how to review changes made to a CRF, review the Determining CRF Data Changes Since Last Verification section in this Quick Reference Guide.

3. Now that you have reviewed the changes, re-verify the CRF by clicking the [Verify] icon on the toolbar.

The “Verify CRF” dialog box opens. The “Verification History” shows

that the CRF was previously verified and then a post-verification edit was made.

The “Verification Comment” field is optional.

4. To verify the CRF again, click .

5. Click the [Close] button to close the CRF. The “Review” tab is displayed again.

The CRF symbol indicates that data have been re-verified and is ready to be approved by an Investigator.

DETERMINING CRF DATA CHANGES SINCE LAST VERIFICATION

You can use the “Highlight” drop-down on the toolbar to determine which fields have been updated since the last verification. To determine CRF data changes since last verification: 1. Open the CRF.

For more information about locating and opening CRFs ready for verification, review the Searching for CRFs Ready for Verification section in this Quick Reference Guide.

2. From the “Highlight” drop-down on the toolbar, select “Changed since last verified”. Fields that have been updated will display a blue highlight. For more information about using the “Audit History” pane to understand more about

the changes that have been made, review the Reviewing Audit History section in this Quick Reference Guide.

Verification


REVOKING A CRF VERIFICATION

If a CRF was verified by mistake, it is possible to revoke the verification. To revoke a CRF verification: 1. Click the “Review” tab.

• The “CRFs” page of the “Review” tab is displayed. 2. In the “Search” section, click the “Verification” drop-down and select “Verified”.

3. Click .

• A list of the verified CRFs is displayed. 4. Click the [-] dash in the title of the “Search” section to collapse the “Search” section so

you can see the results. 5. Open the CRF.

6. To revoke verification, click the [Verify] icon on the toolbar. • The “Verify CRF” dialog box opens. • The “Verification History” section

displays that the CRF was previously verified.

• You can include an optional note about revoking the verification in the “Verification Comment” field.

7. Click .

8. Click the [Close] button to close the CRF. • The “Review” tab is displayed again.

• The CRF symbol indicates that it is no longer verified. The checkmark has been removed.

Review and Approval


SEARCHING FOR CRFS READY FOR APPROVAL

You can easily find both CRFs ready for initial approval and CRFs ready for re-approval for your site from the “Home” tab. To search for CRFs ready for initial approval: 1. On the “Home” tab, in the “Activities” section, click the “Review non-blank CRFs ready

for initial Approval” link or the “Review blank CRFs ready for initial Approval” link. • The “CRFs” page of the “Review” tab is displayed, with a list of the CRFs that are

ready for initial approval. To search for CRFs ready for re-approval: 1. On the “Home” tab, in the “Activities” section, click the “Review non-blank CRFs ready

for Re-Approval” link. • The “CRFs” page of the “Review” tab is displayed, with a list of the CRFs that are

ready for re-approval.

APPROVING A SINGLE CRF

1. Open the CRF. • For more information about locating and opening CRFs ready for approval, review the

Searching for CRFs Ready for Approval section in this Quick Reference Guide. 2. Once you have finished reviewing the data, click the [Approve] icon on the toolbar.

• The “Approve CRF” dialog box is displayed.

• You can include an optional note about the approval in the “Approval Comment” field.

• To retain this comment for use in subsequent CRF approvals during this session (until you log out of RDC), you can click the “Remember comment for subsequent…” checkbox.

3. Click . • The “CRF Approval Signoff” dialog box is displayed.

4. Enter your RDC “Username” and “Password” to apply your electronic signature to the CRF. • You will only need to enter your user name for

the first CRF you approve during an RDC session. For subsequent CRFs, you will only need to enter your password to approve them.

5. Click .

6. In the confirmation dialog box, click . • The CRF has been approved.

Review and Approval


7. Click the [Close] button to close the CRF. • Note that you do not need to save the CRF since the data were not changed. • The “Review” tab is displayed again.

• The CRF symbol has a signature on it, indicating it was approved in addition to a checkmark, indicating it was verified.

APPROVING MULTIPLE CRFS SIMULTANEOUSLY

In addition to approving individual CRFs, you can also approve multiple CRFs simultaneously. UCB requires that the Investigator opens and reviews every single page prior to performing the Multi-Page Approval. Therefore, we recommend you only perform Multi-Page Approval on a patient and visit basis. To approve multiple CRFs simultaneously: 1. Search for CRFs ready for approval.

• For more information about locating and opening CRFs ready for approval, review the Searching for CRFs Ready for Approval section in this Quick Reference Guide.

2. On the “CRFs” page of the “Review” tab, locate the CRFs you want to approve. 3. Open and review each CRF, then close the CRFs.

• The “Review” tab is displayed. 4. In the “Select” column, click the checkbox next to each CRF that you want to approve.

• Note that you could use the “Select All” link to select all of the CRFs on the “Review” tab, if the CRFs pertain to one visit for one patient.

5. The “Select CRFs and…” drop-down displays “Approve”. Click . • The “Approve CRFs” dialog box is displayed. • The “Comment” field is optional.

6. Enter your RDC “Username” and “Password” to apply your electronic signature to the CRFs. • You will only need to enter your user name for


7. Click to approve that the CRFs.

8. On the warning page, click to continue.

9. Click on the confirmation page. • The “Review” tab is displayed.

• The CRF symbols have a signature on them, indicating they have been approved in addition to a checkmark, indicating they have been verified.

Review and Approval


RE-APPROVING A CRF

If any data updates are made to a CRF after it has been approved, RDC automatically requests a re-verification AND a re-approval.

If the CRF has already been re-verified, the symbol will look like: The CRF can now be re-approved.

If the CRF needs to be re-verified and re-approved, the symbol will look like: To re-approve a CRF: 1. On the “Home” tab, in the “Activities” section, click the “Review non-blank CRFs ready

for Re-Approval” link or “Review blank CRFs ready for Re-approval”. • The “Review” page is displayed with a list of the CRFs that are ready for approval.

2. Open the CRF and review any changes made since the initial approval. • For more information about how to review changes made to a CRF, review the

Determining CRF Data Changes Since Last Approval section in this Quick Reference Guide.

3. Now that you have reviewed the changes, re-approve the CRF by clicking the [Approve] icon on the toolbar. • The “Approve CRF” dialog

box opens. • The “Approval History”

displays that the CRF was previously approved and then a post-approval edit was made.

• The “Approval Comment” field is optional.

4. To approve the CRF again, click . • The “CRF Approval Signoff” dialog box is displayed.

5. Enter your RDC “Username” and “Password” to apply your electronic signature to the CRF. • You will only need to enter your user name for


6. Click .

7. In the confirmation dialog box, click . • The CRF has been re-approved.


• The CRF symbol indicates the CRF was re-approved.

Review and Approval


DETERMINING CRF DATA CHANGES SINCE LAST APPROVAL

You can use the “Highlight” drop-down on the toolbar to determine which fields have been updated since the last approval. To determine CRF data changes since last approval: 1. Open the CRF.

• For more information about locating and opening CRFs ready for approval, review the Searching for CRFs Ready for Approval section in this Quick Reference Guide.

2. From the “Highlight” drop-down on the toolbar, select “Changed since last approved”. • Fields that have been updated will display a blue highlight. • For more information about using the “Audit History” pane to understand more about

the changes that have been made, review the Reviewing Audit History section in this Quick Reference Guide.

REVOKING A CRF APPROVAL

If a CRF was approved by mistake, it is possible to revoke the approval. To revoke a CRF approval: 1. Click the “Review” tab.

• The “CRFs” page of the “Review” tab is displayed. 2. In the “Search” section, click the “Approval” drop-down and select “Approved”.

3. Click .

• A list of the approved CRFs is displayed. 4. Click the [-] dash in the title of the

“Search” section to collapse the “Search” section so you can see the results.

5. Open the CRF. 6. To revoke approval, click the

[Approve] icon on the toolbar. • The “Approve CRF” dialog box

opens. • The “Approval History” section

displays that the CRF was previously approved.

• You can include an optional note about revoking the approval in the “Approval Comment” field.

Review and Approval


7. Click . • The “CRF Approval Signoff” dialog box is displayed.

8. Enter your RDC “Username” and “Password” to apply your electronic signature to the CRF. • You will only need to enter your user name for the

first CRF you approve or revoke approval during an RDC session. For subsequent CRFs, you will only need to enter your password to approve or revoke approval.

9. Click .

10. In the confirmation dialog box, click . • You have revoked approval for this CRF.


• The CRF symbol indicates that it is no longer approved. The signature has been removed.

Reports and Special Listings


GENERATING A PATIENT DATA REPORT

The Patient Data Report (PDR) allows you to view and print the data entered into the CRF pages for a patient or patients enrolled at a site. You can select all or some patients and/or CRFs and you have the option of including the audit history and discrepancy information. After a site finishes an RDC study and the closeout visit is performed, access to UCB’s RDC will be removed for the site’s users. However, UCB will provide the Patient Data Reports for all patients entered into RDC at that site, including the audit history, as PDF files on a CD. The CD will be stored as part of the investigator’s site files, according to applicable regulations. To generate a Patient Data Report: 1. Click the “Reports” tab.

2. Click . • The “Patient Data Report” page is displayed. • To generate all CRFs for all patients, you would leave the criteria fields blank and

click . 3. To run a report for one patient, click the “Patient” drop-down and select “Number”.

• A new blank field is displayed below the “Patient” field. 4. Next to the new blank “Patient” field, click the [magnifying glass]

symbol . • Note that you could also type the patient’s number in the “Patient” field. • A list of all patients at the site is displayed.

5. Click the “Quick Select” icon for the patient you want to select.

6. Click to generate the report. • The “Warning” page is displayed.

7. Click to confirm you want to continue. • The most recently submitted report is always displayed at the top of the “Report

Jobs” section.

• The “Status” column indicates the job was submitted. The traffic light symbol in the “Stop Report” column indicates that the report is still being generated. You can click this symbol to stop the report, if desired.

• The “Reports” tab refreshes automatically every 30 seconds. The report may take several minutes to finish. You can navigate to other tabs and screens in RDC while waiting for the report to finish.

• Once the report is ready: • The “Status” changes to “SUCCESS”.

• The traffic light symbol in the “Stop Report” column disappears. • The name of the report (in the “View Report” column) becomes a link.



To view a Patient Data Report: 1. Click the report name link to open the report.

• The report opens in a new window as a read-only Adobe PDF.

• The “Bookmarks” on the left side of the page group CRFs by CRF Type (Domain) and Visit. Clicking a name of a CRF displays that page.

• You can also use the scroll bar on the right side of the screen and the “Previous” and “Next” icons

on the toolbar to locate the CRF pages.

• The report can be printed on a locally installed

printer using the [Printer] icon or saved on a

local hard drive using the [Save a Copy] icon . 2. To close the report and Adobe Reader, click the [Close]

button in the top-right corner of the window. • The “Reports” tab is displayed again. • Reports you generate will be removed from the server after 30 days.

GENERATING A BLANK CASEBOOK REPORT

The Blank Casebook Report produces empty CRFs for a specific casebook. You can print these CRFs as a paper back-up if preferred, but you must also enter the data into the CRFs in RDC.

To generate a Blank Casebook Report: 1. Click the “Reports” tab.

2. Click . • The “Blank Casebook Report” page is displayed. • You can leave the parameters as they are or you can select a specific patient,

casebook, etc.

3. After you enter report parameters, click to generate the report. • The “Warning” page is displayed.

4. Click to confirm you want to continue. • The most recently submitted report is always displayed at the top of the “Report

Jobs” section.

• The “Status” column indicates the job was submitted. The traffic light symbol in the “Stop Report” column indicates that the report is still being generated. You can click this symbol to stop the report, if desired.

• The “Reports” tab refreshes automatically every 30 seconds. The report may take several minutes to finish. You can navigate to other tabs and screens in RDC while waiting for the report to finish.



• Once the report is ready: • The “Status” changes to “SUCCESS”.

• The traffic light symbol in the “Stop Report” column disappears. • The name of the report (in the “View Report” column) becomes a link.

To view a Blank Casebook Report: 1. Click the report name link to open the report.

• The report opens in a new window as a read-only Adobe PDF. • The “Bookmarks” on the left side of the page group CRFs by

Visit and by CRF Type (Domain). Clicking a name of a CRF displays that page.

• You can also use the scroll bar on the right side of the screen and the “Previous” and “Next” icons on the toolbar to locate the CRF pages.

• The report can be printed on a locally installed printer using

the [Printer] icon or saved on a local hard drive using the

[Save a Copy] icon . 2. To close the report and Adobe Reader, click the [Close] button

in the top-right corner of the window. • The “Reports” tab is displayed again. • Reports you generate will be removed from the server after 30 days.

GENERATING A REPORT

Reports are available to list administrative data or they can display clinical data recorded for the patients in RDC. They can be designed to display data for all sites and patients in a study, all sites the currently logged in user has access to or the site the currently logged in user has selected. Reports have a spreadsheet format and can be printed or saved locally.

To run a report: 1. Click the “Home” tab.

• CRAs, DMs, Reviewers and users with a Limited Review role: Depending on the report, data might be listed for all sites in a study, all sites you have access to or just for the one site currently selected. Please select the respective study and site using the “Study and Site” drop-down lists.

• Site Users and Investigators: You are only able to run the report for your site.

2. Click the “Reporting” link in the “Activities” section. • The “Reports Dashboard” window is displayed. • There will be two open browser tabs indicating two

open windows. One tab is called “RDC Onsite” and the second tab is the “Reports Dashboard” window.



3. Select the report you want to run by clicking the radio button (small circle) next to the report name.

4. Click . • A message is displayed stating the report has been submitted.

5. To close the message, click . • The report is now listed at the top of the “My last 5 reports” section of the window.

6. Open the report by clicking the appropriate icon: • The “Open in” column identifies the two formats in which you can open and view the

report:

• Clicking opens the report in Microsoft Excel (if available on your computer).

• Clicking opens the report in Open Office Calc (if available on your computer). Open Office can be downloaded from the Internet for free.

7. In the “File Download” dialog box, click . • A message is displayed asking you to confirm the file is from a trusted source.

8. Click . • The report opens in Excel or Open Office Calc.

• CRAs, DMs, Reviewers and users with a Limited Review role: Depending on the report, data might be listed for all sites in a study, all sites you have access to or the one site currently selected.

• Site Users and Investigators: The data that is displayed is for your site only. • You can format the rows/columns, print and/or save the report as desired. Please

note that in case you change the report, UCB is no longer responsible for its content.

9. To close the report, click the [Close] button in the upper-right corner of the window. • The “RDC Onsite” window and the “Reports Dashboard” window are still open. • Closing a report does not close the “Reports Dashboard” window. It is important to

remember to close the window. Otherwise, the next time you click the “Reporting” link on the “Home” page, you may not realize it is open already.

10. Close the “Reports Dashboard” window by clicking the “Reports Dashboard” tab so it is

visible and then click the [Close] button on the right side of the tab.



FINDING MEDICATIONS, ADVERSE EVENTS OR MEDICAL HISTORY FOR A PATIENT USING SPECIAL LISTINGS

Special Listings allow you to quickly browse and review the data entered into RDC that is medically coded with either WHO-DRL or MedDRA (e.g. the data in the modules Concomitant Medications, Medical History or Adverse Events). To run a Special Listing: 1. Click the “Review” tab. 2. Click the “Special Listings” link on the bar below the “Review” tab name.

• The “Special Listings” page is displayed, with fields in which you can enter parameters, or criteria, for the listing.

• You must select a patient in order to run this listing.

3. Next to the “Patient” field, click the [magnifying glass] symbol . • Note that you could also type the patient’s number in the “Patient” field. • A list of all patients at the site is displayed.

4. Click the “Quick Select” icon for the patient you want to select. 5. The “Listing Type” drop-down defaults to search for adverse event information. When

you want to search for medical history or medications, you can select the option from the list.

6. To run the listing, click . • The adverse event information, including the verbatim term and auxiliary information

from the respective CRF page, is displayed in the list at the bottom of the page. • To review the complete CRF, you would click the CRF symbol.

Documents

Frequently Asked Questions - UCB RDC eLearningucb-rdc-training.c3i-inc.com/Docs/rdc_reference.pdf · Frequently Asked Questions RDC 4.6.6 Quick Reference Guide VERIFICATION 1. What