Study Exit

*The timeline requirements for this form are as follows:
Assessment Time Frame: At the time of study completion or study exit
Submission Time Frame: Within 30 days of study completion or study exit event date

Study Exit

!Note: If the subject exited the study due to a reason associated with COVID-19, indicate “COVID-19 logistical barrier” for reason subject was exited prior to study completion. If subject did not proceed to transplant due to a reason associated with COVID-19, indicate “COVID-19 barrier or risk to patient” for the specific reason subject did not proceed to HCT.

Did the subject complete all protocol required follow-ups?
Report whether the subject completed all protocol required follow-ups by selecting “Yes” or “No.” If the subject completed all follow-ups, select “Yes” and continue with reporting the date of study completion. If the subject did not complete all follow-ups, select “No” and continue with reporting the date of early study exit.

If yes, date of study completion:
Report the date the subject completed the study in DD/MMM/YYYY format. This date should reflect the date the subject completed last clinical follow-up.

If no, date of early study exit:
Report the date the subject was taken off protocol as DD/MM/YYYY format. This date should reflect the date the subject was terminated/withdrawn (e.g. date of death; date determined ineligible after initial enrollment; date transplant cancelled, etc.).

If no, indicate reason subject was exited prior to study completion:
Report the reason the subject was exited prior to study completion, only one reason may be selected.

• Subject did not proceed to HCT, specify below
• Subject withdrawal of consent
• COVID-19 logistical barrier (e.g. institutional no-contact policy)
• Determined ineligible by the study team after initial enrollment
• Discontinued per medical discretion of the protocol PI or Medical Monitor, specify
• Lost to follow-up
• Death
  

If the subject did not proceed to HCT continue with specifying why the subject did not proceed. If the subject was lost to follow-up continue with answering whether three attempts were made to contact the subject.

Specify reason subject did not proceed to HCT:
Indicate the reason the subject did not proceed to HCT.

• Disease progression or relapse
• Insurance or economical barriers
• Patient is found to be too frail or too medically infirm per clinical team assessment
• Patient was found to have psychiatric or compliance issues per clinical team assessment
• Patient and/or family do not want the transplant any more
• Patient was found to be ineligible for the study based on information from research-driven tools included in this study
• COVID-19 barrier or risk to patient (e.g. patient found to be COVID-19 positive pre-HCT, high risk of COVID-19 infection at facility, no ICU or hospital beds, etc.)
• Other, specify
  • If “Other, specify” is selected, specify the reason in the text box (up to 200 characters).

If lost to follow up, were at least three attempts made to contact the subject?
Report whether three attempts were made to contact the subject. If three attempts were made, continue with reporting the date of the last contact attempt.

If yes, date of last contact attempt:
Report the last date that an attempt to contact the subject was made in DD/MMM/YYYY format.

CCG v.4.0 | CRF v.3.0

Copyright © 2004-2024 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.