ICEMR Study Setup Steps


Study Startup Procedures
(*** see Field Computer Status” Spreadsheet for status ***)

Project Setup Notes

Setup Steps

    1. The CRFs are validated in the field
    2. An email is sent to Mary with ALL the study CRFs and a note stating these are the final version.
    3. Email confirmation is received from Don and Clarissa stating agreement that the forms are the final version
    4. The data definition of the final study CRFs is sent to Mary
    5. Mary will review through both the forms and the data definition and coordinate getting answers to questions as appropriate.
    6. Mary will send email to all involved stating ALL CRF and Data Definition-related issues have been resolved
    7. ALL involved will return email to Mary agreeing that ready to move forward
    8. A Project is created on the ICEMR Server and appropriate access rights are granted
    9. Setup is coordinated through Mary and when complete, pilot testing will begin
    10. For pilot test
      • The data entry users for each field computer will enter at least 5 test subjects
      • Changes and modifications will be made as appropriate
    11. When pilot testing is complete, Mary will send out email confirming ready to put project into production mode
    12. Users at each site and Don and Clarissa send email confirmation that pilot testing is complete and there are NO more changes expected.

     

    Going Live!!

    1. Once ALL email confirmations are received:
      • An English training video is made
      • A French training video is made (copy of English video with Frech audio overlay)
      • The pilot data is removed using “Bulk Data Tools” and the project is put into production mode (See How).
    2. A project configuration file is exported from the ICEMR server (See How) and sent via email with a license key to all those involved with computer setup.
    3. Via a GotoMeeting with Mary, the Configuration File is read into EACH Field Computer involved in study (See How)
    4. Mary sends email confirmation of successful import by ALL field computers involved in study
    5. Study website indicates “Ok to Enter Data” and Data on Field Computers begins
  • Study Termination form is a Project Variable
    • Include Study ID on form, check that it is the same as the Project ID
  • Add Screening ID to the first Screening Form for the screening Intervals.
  • Add Study ID Heading variable group.
  • Project ID Mask:   Screen-{SiteCode}-{Seq:0000}

    {SiteCode} = computer name
    {Seq:0000} = 4 digit automatically generated number
  • Project Features
    • Double Data Entry = checked
    • Screening = checked
    • Identifying Subjects
      • Name = Off
      • Reference ID = Yes
    • Setup Reminders
      • CRFs include notes field for data entry notes
      • CRFs should have numbered items
      • No need to repeat General Information section
  • Expressions
    • Put the Screening ID onto the first screening encounter form, compare it to the Reference ID, pop up warning if different.
    • For Baseline encounter, check that the Project ID has been changed to to the Study ID by making sure the word “Screen” is NOT in the Project ID. If Project ID has NOT been changed, hide all variable groups, pop up a message saying “First click “Edit Subject” to enter the study ID into the “Project ID” field.”
    • For “Study Temination Information” form, check that the Study ID field in the same as the Project ID.”
  • To Dos
    • After Pilot Testing.
      • Remove on ICEMR server the people who helped for project setup, except upload person.
      • Change the password of all data entry users on the server, except upload person (Sibe).