Biogen RDC Kit Reference Guide 102411 -...

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RDC Icons RDC Color Scheme There is a color scheme in RDC which denotes the query status of a subject, a CRF page and the queries (discrepancies)

Note: When a patient or CRF may contain both queries for the user (red) and for others (yellow), the icon is displayed as red. determining the overall patient status.

A red icon denotes the presence of a query for YOU to address

A yellow icon denotes the presence of query for someone else to address

A white icon denotes there are no queries at the present time

A white icon with a question mark indicates that there is no data present ?

within the CRF.

User queries always take precedence when


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Patient Icons Icons are associated with the patient numbers and the color of the icon denotes the presence or absence of discrepant data on the patient record. Before any data has been entered on the patient record, the icon is white with a question mark in the middle. After data has been captured, the icon will display as red, yellow or white.




CRF Icons CRF Icons will appear with different colors and symbols depending on the actions that have been performed or are needed.




Data Entry – Best Practices

Enter Subject data within five days of a patient’s assessment or visit

Avoid data entry backlog

Enter data on a page when all data is available to avoid missing data

Follow the CRF Completion Instructions

Save the page only when the entire page is completed to avoid unnecessary queries

Notify the Site Monitor when you are having difficulty entering data on a page




Initial Data Entry In the CRF page there are a variety of data entry fields such as check boxes, numeric and text input fields.

Data can be entered into RDC in a number of ways.

• Data can be entered into a free text box

Free Text Boxes

• Data can be selected from an acceptable list of values

List of Values

• Dates are captured in a pop-up calendar window

List of Value (Dates)

• Data entry may be done by selecting the appropriate check box

Check Boxes




Free Text Box User can enter data into a free text box. Most text boxes have a limit on the number of characters that can be entered so be clear and concise when free typing information. Note: All free typed data must be entered in English. Tip: To navigate from one field to the next you may press the Tab key or you may use your mouse to click in the field.




Data Entry – List of Values You may be able to select from an acceptable list of values (LOV). When this functionality is available for a field, you will see a magnifying glass icon next to the field which indicates you may choose from the acceptable list of values to complete data entry. Tip: The system will allow you to type into a field that contains a LOV, but it is good practice to choose from this list to minimize the risk for errors which could lead to a discrepancy.




Data Entry – List of Values (Dates) Dates are captured in a single date field. With the cursor in this field, a calendar icon is displayed to the right of the field. Use the drop-down list provided to select the month and the up/down arrows to increase or decrease the year. Tip: Alternatively, the highlighted left/right arrows can be used to move forward or backward one month at a time. Once the correct month and year are selected, click the appropriate day to populate the date field.



Data Entry - Check Boxes Another form of data entry is selecting the appropriate check box.




Data Entry Short Cuts TODAY’S DATE Enter a “T” into the date field and when leaving the field will populate with the current date.



Data Entry Short Cuts (continued) YESTERDAY’S DATE Enter a “Y” into the date field and leaving the field will populate the date field with yesterday’s date.



Data Entry Short Cuts (continued) LAST DATE ENTERED VALUE Enter “L” into a date field and leaving the field will populate the date field with the last date entered.



Data Entry Short Cuts (continued) SAVING DATA ON A CRF

MOVING TO THE PREVIOUS OR NEXT AVAILABLE PAGE WITHIN THE VISIT




Modifying Saved Data There may be times when data needs to be added or modified after the CRF has been initially saved. When updating data, the Reason for Change window displays requiring you to choose a reason for making the change to the data field. The reason is defaulted to Site Edit. NOTE: If data is being entered into a field for the first time, you are not prompted to provide a change reason. You are able to copy and paste update text from one Reason for Change window to another window. Tip: It is not always necessary to provide a reason for data change. This may be the case if you are updating data due to a query. Tip: Make all your data updates before saving the page.




Insert Additional CRFs

The Add Visit Page button allows you to insert an unplanned CRF if you have completed data entry on all available CRF pages, but still have additional data to enter.

NOTE: The Add Other Page button should only be used if specifically indicated in the CRF Completion Instructions

Important: Confirm that you are on the correct visit prior to adding a visit page.

Select a Visit t Select a Subject

“Add Visit Page”

Select a CRF

Click Continue

Click Apply New CRF



The Add Visit Page dialog box displays. You will select the CRF that you wish to add to this visit using the radio button next to the CRF Name.

A second Add Visit Page dialog window displays. Always leave the default value in the Select Sub-visit drop down list as the system automatically progresses to the next appropriate sub-visit number.




Click the Refresh button to view the additional/unplanned visit page icon. A new, unplanned Visit Page is added to the Casebook Spreadsheet for the selected visit with a U next to the icon denoting this is an additional/unplanned visit page. NOTE: The new visit page must be completed and saved immediately, or it will not be retained by the system.

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Delete a CRF There may be times when you need to delete a CRF that was created in error. Click the Delete button.




The Delete CRF dialog box displays. Accept the default Change Reason. If necessary, type an optional comment in the Change Comment text box.

Tip: You may also check the box Remember comment… for subsequent Delete CRF operations if you want to use the same comment for subsequent actions within the same session. The comment will only be retained until you log out of RDC. A dialog box will display to confirm you want to perform the deletion.




Deleting Rows For CRFs which collect rows of similar data (such as Medical History), the Delete Row icon can be used to remove one row of data from the CRF.




Once the row is deleted and the CRF is saved the data for that row will no longer be present in the CRF.

Biogen RDC Kit Reference Guide 102411 -...

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