WI-OC-016 - Historical OnCore eCRF Data Storage in Secure Box
Purpose
- Instructions for the storage and retrieval of historical eCRF data from OnCore forms
Responsibilities
- CTMS Application Administrators are responsible for storage and retrieval of eCRF data from OnCore
- Only IT Managers, Application Administrators and members of Single Instance team have access to the Secure Box.
- Application Administrators will respond to requests from study team members for requests for exported data.
Instructions
Export of eCRF data
- From eCRF Export List identify protocols that need to be exported and Assign yourself to row.
- Two versions of data must be exported
- Variable names for Statisticians
- Descriptions for Study Teams
- First uncheck 'Show PHI' in your user menu
- This ensures study initials will be de-identified with the export of data
- From main OnCore Menu navigate to eCRFs/Calendars > Biostat Console > Data Export
- Select Protocol
- Select all Forms by checking all or clicking 'Select All' at bottom
- Check Box 'Use Variable Names'
- Select file type 'Excel' and click 'Export'
- Save As window will open with File name in the format: ProtocolNo-StudyData-MM-DD-YYYY.zip
- Rename file to include PI Name and append with _Variables
- Example: 13541-Hutson-StudyData-02-23-2023_Variables.zip
- Repeat process
- Check box 'Use Descriptions'
- Select file type 'Excel' and click 'Export'
- Save As window will open with File name in the format: ProtocolNo-StudyData-MM-DD-YYYY.zip
- Rename file to include PI Name and append with _Descriptions
- Example: 13541-Hutson-StudyData-02-23-2023_Descriptions.zip
- Select all Forms by checking all or clicking 'Select All' at bottom
- Select Protocol
Storage of eCRF Data to Secure Box
- Application Administrator must be added to Secure Box titled 'OnCore eCRF Data'
- This is managed by DoIT OneTrust - Security Coordinator Review for SecureBox
- Save zip files directly to 'OnCore eCRF Data' folder
- Update Spreadsheet to indicate export is Complete
Respond to Request for eCRF Data
- Information needed to retrieve eCRF data from Box:
- Verify user was a member of the research team and PI has approved request
- OnCore Protocol # and name of PI
- Ask whether they want data with field descriptions as they were in OnCore or the data field variable names
- email address zip file(s) should be sent to
- Navigate to Secure Box and search for OnCore Protocol number
- Select both zip files (ending in _Variables and _Descriptions)
- Select download to your desktop
- Login to REDCap and select 'Send-it' from the top menu
- Enter the following fields:
- To: enter email address provided
- Email Subject: enter 'OnCore eCRF Data for Protocol ######'
- Email Message: Enclosed you will find a zip file containing your eCRF data exported from OnCore. Insert type of file (variables or descriptions)
- Expiration: Select 3 days
- Select file and browse to location on your desktop
- Check 'Receive confirmation' box
- Click 'Send It'
Request User Access to Secure Box
- If user needs to be added see: Add user to Existing Secure Box
- Login to One Trust OneTrust - Security Coordinator Review for SecureBox
- Select 'Update Access to Existing Box'
- Select 'OnCore eCRF Data' from dropdown (existing box)
- Complete fields for Department and Division
- Only Internal users will be added (no external)
- Enter name, email and endpoint (SMPH-IT)
- Request 'Viewer Uploader' Role
- For endpoint enter SMPH-IT
- Login to One Trust OneTrust - Security Coordinator Review for SecureBox
Document History
Reviewed Date | Change Reason | Approver |
---|---|---|
02/23/2023 | New | Sheri Alexander |