See below for example circumstances in which each designation should be used. Records initially saved as UNVERIFIED or INCOMPLETE should eventually be updated as appropriate and saved as COMPLETE. Incomplete/Unverified records that are more than 30 days past the original appointment date should be reviewed and closed out as appropriate on a monthly basis.

COMPLETE (green) = No further action needed / entry is complete

  • Patient in Screening Database successfully consented & enrolled (including patients with research MRIs or pending MRIs who will not return to clinic, even if MRI results not yet known)
  • Patient found not eligible & reason recorded
  • Eligible patient initially needed more time to decide and either declined during follow-up call or did not answer follow-up call (determine preferred treatment course from patient or medical record, if possible)
  • Patient not assessed (record will be reopened & updated, if they return)
  • Patient already successfully treated / not suitable for randomization

UNVERIFIED (yellow) = waiting for results or further action in order to proceed

  • Patient meets pre-MRI eligibility and MRI &/or return visit (if applicable) has been scheduled – i.e., just waiting for MRI results to determine full eligibility (once results known, update record accordingly and save as COMPLETE)
  • Patient needs more time to decide
    • If patient later declines or does not respond to follow-up call, update
      record and save as COMPLETE
    • If patient later decides to participate, add note and save as UNVERIFIED
      until patient returns to clinic to complete enrollment procedures. (Once
      patient returns – or fails to return for enrollment – update record
      accordingly and save as COMPLETE)

INCOMPLETE (red) = Needs attention / there is missing info to address

  • Patient yet to be screened in clinic
  • MRI ordered, but scheduled date of MRI &/or return visit not yet known (once date is entered, save as UNVERIFIED)