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Remote e-Consent Procedure

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What this page tells you

Phone e-consent for the RNS Biomarkers study (829175): get the number from PennChart, call and explain the study, create the eConsent REDCap record, mark Pre-Consent complete to send the survey, sign the same day, then create the RID in CNT Surgical Repository.

  1. pull up patient's PennChart, get phone number to call them
  2. log into the UPenn_CNT_RNS_Biomarkers_829175_eConsent REDCap Project: https://redcap.med.upenn.edu/redcap_v14.4.0/index.php?pid=38020
  3. call patient and introduce yourself as a research coordinator that works in the Penn Epilepsy Center.
    • Explain you are calling about a research project that the patient is eligible for because they have an RNS implanted or will be getting one and by signing the consent form, it would allow us to gather their clinical data to use for research but wouldn't add any additional tasks. It is our hope that this research will help future epilepsy patients.
  4. ask patient if they are interested in learning more about the study
  5. if yes, explain study/consent if further detail (why we are doing study, what data we can collect, how long they will be in study, participation voluntary, etc)

  6. if still interested, you will need to create a new RID in the UPenn_CNT_RNS_Biomarkers_829175_eConsent REDCap Project
    In the "Pre_Consent" Instrument,

    • Blue Fields: enter their first name, last name, and email
    • Green Fields: check "Remote" and "Initial consent"
    • You need to mark the instrument as complete to trigger the survey be sent to their email
      7. Give them time to review consent form and ask if they have any questions
    • write questions down in the REDCap and how you answered them
      8. If they decide to consent, they will need to complete the survey so it comes back to you. They can fill it out on a later date, but you may need to give them access code generated at top of "ICF_Survey" Instrument so they can access the survey again
      9. You will sign and date survey, write consent note, and finish writing down any questions they had and how you answered them (make sure you sign + date on same date they do)
      10. Create new RID in CNT Surgical Repository if needed (check if they are already if REDCap first) and mark they've been consented to RNS and comment you put their consent info in the e-consent REDCap
      11. Save RID and let Nina and I know so we can fill out the rest of their clinical information