Study Exit / Study Completion

*The timeline requirements for this form are as follows:
Assessment Time Frame: At the time of study completion or study exit (if subject experiences an off-protocol qualifying event).
Submission Time Frame: Within 14 days of study completion or study exit event date.

The Study Exit / Study Completion CRF is a common form, which is available at the bottom of the subject’s page in EDC.

!Enrolled or randomized subjects who meet early termination criteria are considered off-study. No study-specific evaluations, procedures or tests are performed after the date the subject was considered to have met off-study criteria. The reason for early termination will be recorded in the study EDC and documented in the medical record.

Please review CRFs to ensure any adverse events, medications, instances or GVHD or infections are updated current to date of study exit.

Did the Subject Complete the Study?:
Indicate if the subject completed the study, which is defined by completion of the final timepoint (Day +365).

Date of Completion or Discontinuation:
Report the date of study completion or discontinuation in DD/MMM/YYYY format.

If the subject did not complete the study, provide the main reason below

This section will appear if “Did the Subject Complete the Study?” is answered No.

Reason for Discontinuation:
Indicate the reason for study discontinuation from the options below. If applicable, reason should align with events reported on the Off Protocol CRF.
• Did not receive MAC or RIC conditioning regimen
• Did not receive MMUD transplant
• Lost to follow-up prior to completing 1-year follow-up visit – Refer to protocol section 6.6.2.2 Lost to Follow-Up for actions which must be taken if a subject fails to be available for visits.
• Subject withdrew consent prior to completing 1-year follow-up visit – Refer to protocol section 6.6.2.1 Subject Withdrawal for data collection / entry guidance.
• Death *
• Other

.* All deaths, regardless of cause, must be reported for subjects on study and for deaths occurring within 30 days of last study evaluation, whichever is longer. Report all deaths on the Death Data form. If the fatal event meets SAE reporting criteria per protocol, report on the AE form. In addition to this CRF, study site must also complete all follow up forms through date of death, and study exit CRF.

Enrolled subjects who meet off-protocol or off-study criteria will be followed in accordance with Protocol Section 6.6.

All subjects who withdraw from the study with ongoing AEs must be followed until resolution of the event, death, or until the site Principal Investigator (PI) concludes that the event is stable with no further improvement anticipated.

If Other, Specify:
This field will only appear in the EDC if “Reason for Discontinuation” is answered Other. Describe the reason in the free textbox (up to 200 characters).

Describe why subject was discontinued prior to completion of study:
Further describe the events which led to the patient exiting the study prematurely (up to 200 characters). This field should not be completed for subjects who complete the study.

Days in Hospital

Total number of inpatient days (day 0 to day 100) in first 100 days post-HCT:
Enter the total number of inpatient days (starting from day 0). If the recipient was discharged and readmitted during the first 100 days, the total should include days hospitalized after being readmitted. When counting the total number of inpatient days, count the day of admission. Do not include the day of discharge.

Ensure that any hospitalizations which meet (S)AE reporting requirements are reported on the Adverse Events CRF, per protocol section 8.7 Adverse Events and Serious Adverse Events.

Did the subject early terminate on or prior to Day 100:
Indicate if the subject early terminated between Day 0 and Day 100. Events which qualify as “early terminated”:

Subjects are considered early terminate if they experience one of the following:
• Did not receive MAC or RIC conditioning regimen
• Did not receive MMUD transplant
• Lost to follow-up prior to completing 1-year follow-up visit
• Subject withdrew consent prior to completing 1-year follow-up visit
• Physician discretion
• Death
• Other

Total number of inpatient days (day 0 to day 365) in first year post-HCT:
This field will appear and is required if “Did the subject early terminate on or prior to Day 100” is answered No.

Report the total number of inpatient days (starting from day 0). If the recipient was discharged and readmitted during the first 365 days, the total should include days hospitalized after being readmitted. When counting the total number of inpatient days, count the day of admission.

Ensure that any hospitalizations which meet (S)AE reporting requirements are reported on the Adverse Events CRF, per protocol section 8.7 Adverse Events and Serious Adverse Events.

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