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Oracle Clinical Remote Data Capture System (RDC) Presentation. Introduction to RDC Application (v4.5.0). *** Please Note ***.
Introduction to RDC Application (v4.5.0)
The information contained in the following presentation is for the general training and review of Investigator Sites and employees of Biogen Idec participating in studies utilizing Oracle Clinical Remote Data Capture.
This presentation should not be reproduced, republished or retransmitted without the prior consent of Biogen Idec.
Data entered by site staff
Site staff correct eCRF
Discrepancy closed by system, CRA or DM
Site staff correct eCRF or comment on entered data
CRA reviews changes or comments
CRA performs SDV
Investigator approves eCRF Casebook
CRA verifies eCRF
*Manual discrepancies may be generated by the CRA or CDA anytime after data
has been source verified. These discrepancies will follow the same flow as above.
access to the Biogen Idec web portal
To be compliant with the FDA Guidelines: 21 CRF Part 11 it is imperative that you
DO NOT SHARE YOUR USERNAME OR PASSWORD
Once logged into Biogen Idec Website…
The OC RDC log in screen will appear
Click Connect to log in
A separate OC-RDC window will also appear
This screen must remain open to maintain your connection to OC RDC however you may click on the minimize icon if needed
If you have access to multiple studies the Change Study box will appear
Note: If you only have access
to one study hit F9. This will
automatically select the study for you
The activity list window will appear
The list allows you to choose the activity you would like to perform, you can browse all of the data, review eCRFs with discrepancies, or review eCRFs with discrepancies for other users.
The Search Window provides you with the ability to filter on certain areas of data you would like to work on
Using the search window you can :
Note:If no data has been entered for a site then at least the patient must be selected
Search Window Criteria
Once you select the search criteria the OC-RDC Spreadsheet will appear
Spreadsheet screen set up:
OC-RDC navigation functions are similar to Microsoft Windows
Use the Menu Bar to..
Use the Tool Bar to…
Add a Patient
Add Investigator Comment
Create a Manual Discrepancy
Use Key Commands to…
Example: Press Alt + I to select Insert function from the drop down menu. From this menu, Alt + T will insert a new patient
…..Or use Function Key during eCRF entry/review to…
F6 Insert Patient
CTRL + U Clear Data Field
CTRL + Shift + F11 Add Operator Comment
F1 Get Help
Click on Help RDC Help Topics
NOTE: If no eCRF is selected then only Study Information tab will be available
Do not enter any details (visit date or comment) in this section UNLESS no data will be collected for that eCRF. In that case only the Blank field can be used
Note: Once Ok is clicked, the next eCRF for this patient will be displayed
This will automatically mark the section blank
Pages that can be marked blank will be study specific and defined by the study team
To display contents of eCRF, click in Visit field and Press Tab key
Begin Data Entry by typing in the responses and using the Tab Key to navigate from one field to another
Tip: Be sure to have the study specific eCRF Completion Guidelines to reference during entry – this will help avoid unnecessary discrepancies
Some data fields are not enterable and will have a List of values (LOV) to choose from
To select from the LOV
This will place the selection in the data field
Tip: you can always Press F1 if you have any questions or need additional help
Dates can be entered using the following formats:
Times should be entered using a 24-hour clock. After entering in the numerical value, press the Tab Key. OC-RDC will automatically add the ‘:’
Log Pages are kept at the end of the eCRF book and can be located by using the page drop down menu
Note: Log pages are displayed in numerical order and should be entered as such. If additional pages are needed then an Unplanned eCRF can be added
Adding and Unplanned eCRF
From drop down menu select Insert Visit
Use drop down arrow in the right hand portion of window to select the appropriate eCRF
Tip: To easier identify the appropriate eCRF to select, please refer to eCRF Completion Guidelines for page name descriptions
Adding an unplanned visit
Note: the Unplanned Visit will be inserted after the visit that is open, i.e. if an unplanned visit occurs post Visit 2 the cursor should be on Visit 2 when you add the visit.
Indicator Questions (Yes/No or Done/Not Done) will more easily direct the flow of data entry
Example: ‘Any data for this section?’ Y/N question:
Note: Question Group is a group of questions with a common indicator, generally a polar question. eCRFs can have multiple questions groups.
Repeating Question Groups
Note: This error message can be avoided it is best to click the on the top corner of the eCRF after entry is complete and avoid using the Tab Key
Key Point Summary
You can easily Browse Data by…
Types of Discrepancies:
Note: To avoid an abundance of discrepancies, if possible - it is best to address the Univariate discrepancies immediately. If the discrepancy can not be addressed immediately, click Save to address at a later time.
Manual discrepancies DO NOT close automatically, meaning once the discrepancy is addressed the user will need to select the appropriate action to close.
‘Reason for Change’…
From the LOV, you may select only the following options:
Note: Reason for Change will be stored as an Audit to the data base
Example: Does subject have any ongoing or resolved medical or surgical history? has been marked No, however source documentation indicates otherwise. Please update data accordingly.
Send to Data Manager
Send to CRA with Internal Comment
Discrepancy Closed Automatically or Manually by CRA
To end your session:
Note: DO NOT click on the “X” on the Data Capture spreadsheet as this will result in closing down the RDC session and entered data may be lost
Once the verification process is complete for all eCRFs
The casebook is ready for Investigator approval
Provides guidance that states the FDA will consider:
At the end of each study…
CDs and will include:
Under NO circumstances should anyone use another persons account for the purpose of data capture.