Purpose

1. Instructions for the storage and retrieval of historical eCRF data from OnCore forms

Responsibilities

1. CTMS Application Administrators are responsible for storage and retrieval of eCRF data from OnCore
2. Only IT Managers, Application Administrators and members of Single Instance team have access to the Secure Box.
3. Application Administrators will respond to requests from study team members for requests for exported data.
   

Instructions

• Export eCRF data
• Save to Secure Box
• Request for eCRF data
• Request User Secure Box

Export of eCRF data

1. From eCRF Export List identify protocols that need to be exported and Assign yourself to row.
2. Two versions of data must be exported
   1. Variable names for Statisticians
   2. Descriptions for Study Teams
3. First uncheck 'Show PHI' in your user menu
   1. This ensures study initials will be de-identified with the export of data
4. From main OnCore Menu navigate to eCRFs/Calendars > Biostat Console > Data Export 
   1. Select Protocol
      1. Select all Forms by checking all or clicking 'Select All' at bottom
         1. Check Box 'Use Variable Names'
         2. Select file type 'Excel' and click 'Export'
         3. Save As window will open with File name in the format: ProtocolNo-StudyData-MM-DD-YYYY.zip
         4. Rename file to include PI Name and append with _Variables
            1. Example: 13541-Hutson-StudyData-02-23-2023_Variables.zip
      2. Repeat process
         1. Check box 'Use Descriptions'
         2. Select file type 'Excel' and click 'Export'
         3. Save As window will open with File name in the format: ProtocolNo-StudyData-MM-DD-YYYY.zip
         4. Rename file to include PI Name and append with _Descriptions
            1. Example: 13541-Hutson-StudyData-02-23-2023_Descriptions.zip

Storage of eCRF Data to Secure Box

1. Application Administrator must be added to Secure Box titled 'OnCore eCRF Data'
   1. This is managed by DoIT  OneTrust - Security Coordinator Review for SecureBox
2. Save zip files directly to 'OnCore eCRF Data' folder
3. Update Spreadsheet to indicate export is Complete

Respond to Request for eCRF Data

1. Information needed to retrieve eCRF data from Box:
   1. Verify user was a member of the research team and PI has approved request
   2. OnCore Protocol # and name of PI
   3. Ask whether they want data with field descriptions as they were in OnCore or the data field variable names
   4. email address zip file(s) should be sent to
2. Navigate to Secure Box and search for OnCore Protocol number
3. Select both zip files (ending in _Variables and _Descriptions)
4. Select download to your desktop
5. Login to REDCap and select 'Send-it' from the top menu
6. Enter the following fields:
   1. To: enter email address provided
   2. Email Subject: enter 'OnCore eCRF Data for Protocol ######'
   3. Email Message: Enclosed you will find a zip file containing your eCRF data exported from OnCore. Insert type of file (variables or descriptions)
   4. Expiration: Select 3 days 
   5. Select file and browse to location on your desktop
   6. Check 'Receive confirmation' box
   7. Click 'Send It'

Request User Access to Secure Box

1. If user needs to be added see: Add user to Existing Secure Box
   1. Login to One Trust OneTrust - Security Coordinator Review for SecureBox
      1. Select 'Update Access to Existing Box'
      2. Select 'OnCore eCRF Data' from dropdown (existing box)
      3. Complete fields for Department and Division
      4. Only Internal users will be added (no external)
      5. Enter name, email and endpoint (SMPH-IT)
      6. Request 'Viewer Uploader' Role
      7. For endpoint enter SMPH-IT

Document History

Document History

Reviewed Date	Change Reason	Approver
02/23/2023	New	Sheri Alexander

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