Recipient Inclusion Exclusion Criteria Not Met

*The timeline requirements for this form are as follows:
Assessment Time Frame: At the time of eligibility assessment (where recipient inclusion exclusion criteria not met)
Submission Time Frame: As soon as possible after eligibility criteria are assessed, and for subsequent assessments if subject previously screen failed

*Note: Form comes due when Screen Fail date is automatically populated as a system generated field on the Enrollment and Randomization form (via RTSM integration). A separate instance should be completed on this form for each instance of eligibility criteria assessment. This form allows up to 4 instances for recipient inclusion/exclusion criteria not met. Select the “+New” button to start a new Recipient Inclusion/Exclusion Criteria Not Met instance.

Conditioning Regimen:
Select which conditioning regimen the subject was assigned.

Protocol:
Select the master protocol version (not ISA version) the subject was enrolled to the study from the radio button options.

If the correct protocol version is not available for selection, contact the study inbox at ACCELERATE@nmdp.org for assistance.

Screen Number:
Select which screening number instance this screen fail is associated with. The first recipient screen fail should be reported as “Initial screen fail,” followed by subsequent numbering of rescreen fails (1, 2, 3). Note: the system only allows a total of 4 recipient instances on the Recipient Inclusion Exclusion Criteria Not Met form, and therefore can only specify up to 4 unique screen fail instances in this field.

Inclusion Criteria Not Met and Exclusion Criteria Met:
Select “New Section” and complete for each instance of inclusion criteria not met or exclusion criteria met (up to 20 instances)

Criterion type:
Select the criterion type (Inclusion or Exclusion) that contributed to the screen fail.

Criterion ID:
Select the number/ID associated with the criterion type (either Inclusion or Exclusion) that contributed to the screen fail. Refer to the protocol listed above in “Protocol” field above to determine which ID is associated with which criterion and conditioning regimen.

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