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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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