Oracle Clinical Remote Data Capture System (RDC

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Oracle Clinical Remote Data Capture System (RDC)
Presentation

• Introduction to RDC Application (v4.5.0)

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Please Note

• 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.  

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Agenda

• Discussion of RDC
• Log-in and Navigation of RDC
• Demonstration
• Data Capture Procedures
• Demonstration
• Browsing Data
• Discrepancy Management
• Demonstration
• Logging Off
• eCRF Verification
• eCRF Approval
• Archival
• Technical and Clinical Support
• QA

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What is RDC?

• Remote Data Capture (RDC) is a Web-based tool
  used at Investigator Sites to record, store and
  manage clinical study data. This process allows
  for Investigator Site and Sponsors to view
  clinical data directly in the sponsors Oracle
  Clinical database at time of entry, address any
  discrepant data as needed and sign or approve
  electronic case report forms (eCRFs)

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Benefits of RDC

• Improves Overall Data Quality by allowing
• the Sponsor to have real time access to the data
• discrepant data to be immediately identified and
  resolved in a timely manor
• CRAs to monitor site data remotely and prepare
  for monitoring visits
• No paper!

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Workflow in RDC
Data entered by site staff
System-generated discrepancies
Site staff correct eCRF
Discrepancy closed by system, CRA or DM
Changes rejected
Site staff correct eCRF or comment on entered data
Validation checks
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.
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Responsibilities Within RDC

• Study Coordinator
• Data Entry and review of eCRFs
• Review and Respond to Discrepancies
• Create Investigator comments in data field when
  needed
• Notify Investigator when eCRFs are ready for
  review and approval
• Investigator
• Data Entry and review of eCRFs
• Review and Respond to Discrepancies
• Approve (sign) eCRF Casebook

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Responsibilities Within RDC

• Clinical Research Associate (CRA)
• Review Data and create Manual Discrepancies when
  needed
• Advise Site Coordinator with discrepancy and data
  entry questions
• Close discrepancies
• Perform Source Verification, marking the eCRFs as
  verified
• Data Management
• Review and perform cross checks of data and
  create Manual Discrepancies when needed
• Provide metrics and status to Study Team
• Advise CRA with discrepancy and data entry
  questions
• Lock clean eCRFs
• Lock Database

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• Login and Navigation

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LoginInitial Information

• Prior to training you will receive
• Username and Password that will provide you with
  secure
• access to the Biogen Idec web portal
• Web address for Oracle Clinical RDC Training data
  base
• Username and Password for OC-RDC
• Post OC RDC training you will receive
• Access to OC-RDC Production data base
• The same username and password will be used for
  both test and production data base

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LoginPasswords
Passwords

• Passwords must be changed after initial login
• They must be at least 8 characters in length
• Passwords will expire every 90 days
• Passwords cannot be re-used
• To be compliant with the FDA Guidelines 21
  CRF Part 11 it is imperative that you
• DO NOT SHARE YOUR USERNAME OR PASSWORD

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LoginPasswords

• To update your password
• At the Log in Screen click on Change Password
  under the Login button

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LoginLaunch Application

• Once logged into Biogen Idec Website
• Click on the following link to launch OC-RDC
• http//carl.biogenidec.com/opa45/rdclaunch.h
  tm
• Click Log In

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LoginLaunch Application

• The OC RDC log in screen will appear
• Enter
• OC User Name
• Password
• Database Name (PCDS)
• Click Connect to log in

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Log In Launch Application

• 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

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Log In Launch Study

• If you have access to multiple studies the Change
  Study box will appear
• Click the appropriate study
• Click Ok
• Note If you only have access
• to one study hit F9. This will
• automatically select the study for you

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Navigation News Updates

• News Updates
• Any news updates will appear in a centered pop-up
  window
• News updates can be study related and will also
  be used to alert you to scheduled maintenance
• Make use of scroll bars to review any new or
  existing news messages
• If no news is available or active then the search
  window is automatically activated

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Navigation Activities Window

• 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.
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Navigation Search Window

• To refine your search you can click on Search an
  this window will appear
• The Search Window provides you
  with the ability to filter on certain
  areas of data you would like to work
  on

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Navigation Search Window

• Using the search window you can
• Select and display only the casebook you need to
  work on
• Select and display multiple patients by visit or
  visit date
• Browse certain types of eCRFs
• Search for eCRFs that need to be verified and/or
  signed by the Investigator
• NoteIf no data has been entered for a site then
  at least the patient must be selected

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Navigation Search Window Criteria

• Search Window Criteria
• Book Dependent on type of study
• Non cohort studies use only one book which will
  default
• For Cohort studies select the appropriate book
  assigned by patient
• Site Study sites will use their default Site,
  CRAs with more than one site will need to select
  the appropriate site
• Patients Used to define a range of patients by
  study number

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Navigation Search Window Criteria

• Visits/Pages Used to define a range of
  visits/pages
• CRF Status
• Used to filter for complete, partially complete
  or blank eCRFs
• Discrepancy status can be used to filter for
  actionable (red), un-actionable (yellow) or
  eCRFs which have no discrepancies
• CRAs can filter for Unverified pages to prepare
  for their next monitoring visit
• Approved eCRFs can be used to confirm that the
  Investigator has approved the data on each of the
  subjects at their site.

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Navigation Search Window Criteria

• Date Window Can be used to define the Date range
  that a page was initially entered
• Data Specific drill down menu which can be used
  to filter on specific data points entered

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NavigationOC-RDC Spreadsheet
Once you select the search criteria the OC-RDC
Spreadsheet will appear
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Navigation OC-RDC Spreadsheet

• Spreadsheet screen set up
• Rows Patients (Additional patients can be
  displayed by using the drop down)
• Columns Pages
• Tabs Visit (Tabs Drop Down should always
  display by Visit)

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Navigation Menu and Tool Bar

• OC-RDC navigation functions are similar to
  Microsoft Windows
• Example
• Use the Menu Bar to..
• File Save
• Insert Patient
• Use the Tool Bar to
• Add a Patient
• Add Investigator Comment
• Create a Manual Discrepancy

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Navigation Key Commands

• Use Key Commands to
• Perform all the same tasks you would using your
  mouse
• 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
• F10 Save
• CTRL U Clear Data Field
• CTRL Shift F11 Add Operator Comment
• F1 Get Help

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Navigation OC-RDC Icons

• For eCRF icon description
• Click on Help RDC Help Topics

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Navigation Selecting a Patient

• If more than eight patients are selected from the
  search window then a drop down box is available
• Click on the drop down box and the patients are
  listed in groups of eight in numerical order
• Click on the necessary group and the patients
  within that group will be displayed on the main
  screen

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Navigation Selecting an eCRF

• Once a patient is selected
• Click on appropriate tab to select desired visit
• Note If desired visit is not displayed at the
  top, click on the to display
  additional visits

• Use the bottom navigation bar to view all eCRFs
  scheduled per visit
• Example Screening Visit may have 15 expected
  pages but only 11 are displayed

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Navigation Selecting an eCRF

• To Open a new eCRF.
• Single Click in empty cell
• eCRF Icon will appear

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Navigation Task Tabs

• Task Tabs
• Summary Overall Visit summary. If a page is
  clicked on, then the overall summary of that page
  is given
• Discrepancies Displays all the discrepancies
  for a specific page. It is from this tab that
  control of discrepancy management takes place
• Verification Tab used by CRA to verify eCRFs

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Navigation Task Tabs

• Approval Tab used by Investigator to approve
  eCRFs
• Audit Trail Tab used by all users to monitor
  changes made to data after initial entry has been
  saved
• NOTE If no eCRF is selected then only Study
  Information tab will be available

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DemonstrationLog In and Navigation

• Key Point Summary
• Log In to Biogen Idec Web Portal
• Click on RDC link and Log in to OC-RDC
• Select Study
• Select Search Criteria
• Select Patient
• Select Visit
• Open eCRF
• Review Tool and Menu Bars

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• Data Capture Procedures

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Data Capture Procedures Subject Identification

• Patient numbers will be pre-entered by Data
  Management staff into the system when the
  subjects are randomized.
• Subject ID numbers will be seven digits the first
  three digits will be the site number, then a (-)
  followed by the subject ID number.
• 123-456
• The Study coordinator will select the appropriate
  patient number
• This patient number will automatically populate
  on all eCRF pages for that subject

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Data Capture Procedures Header Information

• Header Information
• 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

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Data Capture Procedures Marking an eCRF Blank

• To mark an eCRF Blank
• Click in the blank box in the header
• Click OK on the Forms box

Note Once Ok is clicked, the next eCRF for this
patient will be displayed
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Data Capture Procedures Marking an eCRF Blank

• For eCRF sections that will not have data
  entered..
• Click on correct tab
• Click the Blank box

This will automatically mark the section blank
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Data Capture Procedures Marking an eCRF Blank
Pages that can be marked blank will be study
specific and defined by the study team
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Data Capture Procedures Expanding eCRF Screen

• To Expand eCRF Screen for better viewing
• Double Click on the Patient Information bar

• Click and drag mouse to outline desired size

• Press Done

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Data Capture Procedures Data Entry

• 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
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Data Capture Procedures List of Values

• Some data fields are not enterable and will have
  a List of values (LOV) to choose from
• To select from the LOV
• Click on the LOV symbol or Press F9
• Select from the LOV
• Click Ok
• This will place the selection in the data field
• Tip you can always Press F1 if you have any
  questions or need additional help

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Data Capture Procedures Dates and Times

• Dates can be entered using the following formats
• mm/dd/yy
• mm/dd/yyyy
• mmddyy
• mmddyyyy
• DDMMMYY
• DDMMMYYYY
• 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

Note Certain date fields allow the entry of
Partial Dates and other date fields will prompt a
discrepancy stating the it is not a complete
date. If the complete date is unknown it is best
to close the discrepancy immediately.
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Data Capture Procedures Log Pages
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
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Data Capture Procedures Unplanned eCRF

• 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

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Data Capture Procedures Unplanned Visit

• Adding an unplanned visit
• Open the current visit
• From drop down menu select Insert Visit
• Click Ok
• 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.

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Data Capture Procedures Indicator Questions

• 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
• If answered Yes, curser moves to the next data
  field on the eCRF
• If answered No, entry skips to next question
  group or page

Note Question Group is a group of questions with
a common indicator, generally a polar question.
eCRFs can have multiple questions groups.
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Data Capture ProceduresRepeating Question Groups

• Repeating Question Groups
• Repeating questions groups are usually displayed
  in a table format
• An eCRF can have several repeating question
  groups
• Once in a repeating question group question, the
  title bar will indicate how many records exist
  and which record you have currently selected.

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Data Capture Procedures Delete Row Function

• Data Entry for eCRFs with repeated questions
  groups will prompt an error message if the Tab
  Key is pressed in the last data field of a blank
  repeat
• Click Ok
• Select CRF from Menu Bar
• Select Delete Row
• Click to close eCRF

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
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Data Capture Procedures Closing or Deleting eCRFs

• Closing an eCRF
• Click on the X in the upper right hand corner
  of the eCRF
• or
• Press Tab Key when in last data field
• Deleting an eCRF
• Select eCRF
• Use Drop-down menu Edit Delete CRF
• or
• Press Shift F6 and select Delete CRF

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
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Data Capture ProceduresDemonstration

• Key Point Summary
• Header Information
• Marking eCRF and section of eCRF Blank
• Expanding eCRF screen
• Enterable Data Fields
• Non Enterable Data Fields (LOV)
• Dates and Times
• Log Pages
• Adding Unplanned eCRF
• Adding Unplanned Visit
• Indicator Questions and Question Groups
• Repeating Question Groups and Delete Row Function
• Closing an eCRF
• Deleting an eCRF

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• Browsing Data

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Browsing Data

• You can easily Browse Data by
• Using the Search Window function to select
  specific data
• or
• Using the Tab Key to go through each data field
  from eCRF to eCRF
• or
• Using your Mouse, Point and Click

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Browsing DataDemonstration

• Key Point Summary
• Search Window Function
• Tab Key
• Point and Click

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• Discrepancy Management

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Discrepancy ManagementTypes of Discrepancies

• Types of Discrepancies
• Univariate Discrepancies occur immediately upon
  data entry for certain data fields and generate
  because data is considered incorrect or left
  blank
• Multivariate Discrepancies generate the next day
  after the Oracle Clinical system runs the new
  data through a batch validation process.
• Manual Discrepancies usually created by
  CRAs/Data Management during source
  verification/data review. Manual discrepancies DO
  NOT close automatically, meaning once the
  discrepancy is addressed the user will need to
  send to CRA to be closed

• 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.

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Discrepancy ManagementIdentifying Discrepancies
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Discrepancy Management Identifying Discrepancies

• Icon Description
• Active
• requires action on your part in order to resolve
  (RED icon)
• Other
• requires action on someone elses part to resolve
  (YELLOW icon)
• No Action
• requires no action, no active (open)
  discrepancies (WHITE icon)

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Discrepancy Management Viewing Discrepancies

• To view active discrepancies
• Open on desired eCRF
• Click on Discrepancies under Task Tab

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Discrepancy Management Resolving
Univariate/Multivariate Discrepancies

• Steps to Closing a Univariate or Multivariate
  Discrepancy
• Update data point
• Provide Reason for Change
• Discrepancy will close out
• OR
• Send to CRA with an internal comment describing
  why error can not be corrected. CRA will close
  discrepancy when source verification has been
  completed.
• Manual discrepancies DO NOT close automatically,
  meaning once the discrepancy is addressed the
  user will need to select the appropriate action
  to close.

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Discrepancy Management Resolving
Univariate/Multivariate Discrepancies
Reason for Change

• automatically displays when a change is made to a
  Complete eCRF
• is required for all updates to the database once
  the data has been entered and verified.
• From the LOV, you may select only the following
  options
• Data Entry Error select if error was made during
  data entry
• Investigator Correction select if changes are
  made to patient source date

Note Reason for Change will be stored as an
Audit to the data base
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Discrepancy Management Resolving Manual
Discrepancies

• Steps to Resolving a Manual Discrepancy
• Update data point
• Add comment in the Internal Comment section
  describing the change or reason for no
  change
• Send to CRA
• 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.

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Discrepancy ManagementRouting Discrepancies
Open Discrepancy
Send to Data Manager
Address Discrepancy
Send to CRA with Internal Comment
Discrepancy Closed Automatically or Manually by
CRA
Address Discrepancy
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Data ManagementDemonstration

• Key Point Summary
• Review Icons
• View Discrepancies
• Address Discrepancies
• Routing Discrepancies
• Creating an Manual Discrepancy

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• Logging Off

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Logging Off

• To end your session
• Close any open eCRFs
• Select File gt Exit menu command from the main
  screen
• 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

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• Verification Process

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Verification Process

• Verification Process
• Once the site has completed entry and all
  relevant discrepancies have been resolved for an
  eCRF, the page is ready for verification
• CRA verifies the information recorded on the eCRF
  matches the information in the source documents
• CRA marks the eCRF as verified

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• Investigator Approval

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Investigator Approval

• Once the verification process is complete for all
  eCRFs
• Data has been reviewed for logic and accuracy
• All discrepancies are resolved
• The casebook is ready for Investigator approval
• The Investigator will select the appropriate
  Casebook and click on Approval Tab
• Investigator must enter his/her Oracle Clinical
  password to grant approval status to the Casebook

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21 CRF Part 11 Electronic Records Signatures

• Provides guidance that states the FDA will
  consider
• Electronic records equivalent to paper records
• Electronic signatures equivalent to traditional
  handwritten signatures

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• Archival of Data

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Archival of Data

• At the end of each study
• The RDC study will be decommissioned and on-line
  data will no longer be available to site staff
• Each site will receive a CD containing data for
  their site patients only
• CDs and will include
• Patient data entered
• Patient discrepancy information
• Audit trail information

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• Technical and Clinical Support

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Technical and Clinical Support

• Technical Support Help Desk
• 1.888.927.8233
• Toll free number is posted on the RDC web page.
• Hours of technical support are 0900 1700 EST.
  
• Call the help desk for any of the following
  issues
• Firewall issues at site
• Forgotten passwords
• Expired accounts
• New Accounts
• Notify Help Desk immediately if a user has left
  the study.
• Under NO circumstances should anyone use
  another persons account for the purpose of data
  capture.
• Clinical Support Contact the lead CRA for the
  study for all clinical support

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OC-RDC Review
?Questions?