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					Oracle Clinical Remote Data Capture System (RDC) Presentation
Introduction to RDC Application (v4.5.0)

***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.

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 Q&A

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)

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!

Workflow in RDC
Data entered by site staff Systemgenerated discrepancies Validation checks Site staff correct eCRF
Changes rejected

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.

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

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

Login and Navigation

Login
Initial 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

Login
Passwords
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

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

Login
Launch Application
Once logged into Biogen Idec Website…
 Click on the following link to launch OC-RDC:

http://carl.biogenidec.com/opa45/rdclaunch.htm
 Click Log In

Login
Launch Application
The OC RDC log in screen will appear Enter
 OC User Name  Password  Database Name (PCDS)

Click Connect to log in

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

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

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

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.

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

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

Note:If no data has been entered for a site then at least the patient must be selected

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

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 eCRF‟s - Discrepancy status can be used to filter for actionable (red), un-actionable (yellow) or eCRF‟s which have no discrepancies - CRA‟s 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.

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

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

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)

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

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 F10 CTRL + U CTRL + Shift + F11 F1 Insert Patient Save Clear Data Field Add Operator Comment Get Help

Navigation
OC-RDC Icons
• For eCRF icon description
Click on Help RDC Help Topics

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

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

Navigation
Selecting an eCRF
To Open a new eCRF….
Single Click in empty cell

eCRF Icon will appear

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 eCRF‟s

Navigation
Task Tabs
 Approval – Tab used by Investigator to approve eCRF‟s  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

Demonstration
Log 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

Data Capture Procedures

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

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

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

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

Data Capture Procedures
Marking an eCRF Blank
Pages that can be marked blank will be study specific and defined by the study team

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

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

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

Data Capture Procedures
Dates and Times
Dates can be entered using the following formats: • mm/dd/yy • mm/dd/yyyy • mmddyy • mmddyyyy • DDMMMYY • DDMMMYYYY
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.

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 „:‟

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

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

Data Capture Procedures
Unplanned Visit
Adding an unplanned visit
 Open the current visit  From drop down menu select Insert  Click Ok

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.

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.

Data Capture Procedures
Repeating 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.

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

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

Data Capture Procedures
Demonstration
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

Browsing Data

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

Browsing Data
Demonstration
Key Point Summary Search Window Function Tab Key Point and Click

Discrepancy Management

Discrepancy Management
Types 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 CRA‟s/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.

Discrepancy Management
Identifying Discrepancies

Discrepancy Management
Identifying Discrepancies
Icon Description

Active
• requires action on your part in order to resolve (RED icon)

Other
• requires action on someone else‟s part to resolve (YELLOW icon)

No Action
• requires no action, no active (open) discrepancies (WHITE icon)

Discrepancy Management
Viewing Discrepancies
To view active discrepancies… Open on desired eCRF

Click on Discrepancies under Task Tab

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.

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

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.

Discrepancy Management
Routing Discrepancies
Open Discrepancy Send to Data Manager

Address Discrepancy

Send to CRA with Internal Comment

Discrepancy Closed Automatically or Manually by CRA

Address Discrepancy

Data Management
Demonstration
Key Point Summary Review Icons
View Discrepancies
Address Discrepancies Routing Discrepancies Creating an Manual Discrepancy

Logging Off

Logging Off
To end your session:
 Close any open eCRFs  Select File => 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

Verification Process

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

Investigator Approval

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

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

Archival of Data

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

Technical and Clinical Support

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 09:00 – 17:00 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

OC-RDC Review

?Questions?


				
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