Donor Inclusion Exclusion Criteria

*The timeline requirements for this form are as follows:
Assessment Time Frame: At the time of eligibility assessment.
Submission Time Frame: As soon as possible after eligibility criteria are assessed.

*A separate instance should be complete on this form for each donor evaluated (for both donors that have been screen failed or used at Recipient Enrollment/Randomization). This form allows up to 4 instances for donor inclusion/exclusion. Select the “+New” button to start a new Donor Inclusion/Exclusion instance.

GRID of unrelated donor infused:
The Global Registration Identifier for Donors (GRID) is a unique identifier assigned to an individual donor by the donor registry.

Report the donor’s GRID. This should be entered as the full 19 characters without dashes or symbols.

The GRID should always be used for the donor identifier, however if the donor has not been assigned a GRID the Registry Donor ID should be reported. If the length of the data field does not allow for full data entry of the Registry Donor ID, contact the study inbox (ACCELERATE@nmdp.org) for assistance.

Was this the Donor used at Recipient Enrollment/Randomization or related to a Screen Fail:
Specify if the donor was used at Recipient Enrollment/Randomization or related to a Screen Fail.

If related to a Screen Fail, select Screen Fail and specify which instance this applies to in the next field.

Was this the Donor used at Recipient Enrollment/Randomization or related to a Screen Fail:
Select which screen fail instance this donor is associated with. The first donor 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 donor instances on the Donor Inclusion/Exclusion form, and therefore can only specify up to 4 unique screen fail instances in this field.

Inclusion Criteria

• Must be unrelated to the subject and high-resolution HLA-matched at 4/8, 5/8, 6/8, or 7/8 (HLA-A, -B, -C, and -DRB1)
• Donor must be typed at high-resolution for a minimum of HLA-A, -B, -C, -DQB1, and -DPB1
• Age 16-35 at the time of workup request for PBSC donation
  • Note: Donors 16-17 years old are allowed per donor registry-specific regulations.
• Meet the donor registries’ medical suitability requirements for PBSC donation
• Must undergo screening, testing, and determination of eligibility according to current Food and Drug Administration (FDA) requirements as defined in 21 CFR 1271 Subpart C and applicable guidance documents
• Must agree to donate PBSC
• Must have the ability to give informed consent according to standard (non-study) informed consent according to applicable donor regulatory requirements

Answer each inclusion criteria data field with Yes or No as appropriate. Donor criteria information should be received from the apheresis or collection center that completed the donor work-up and donation process.

Exclusion Criteria

• Donor unwilling or unable to donate
• Presence of DSA in the recipient

Answer each exclusion criteria data field with Yes or No as appropriate. Donor criteria information should be received from the apheresis or collection center that completed the donor work-up and donation process.

Eligibility

Is the donor eligible based on Inclusion and Exclusion criteria:
Report whether the donor is eligible:

• Indicate ‘Yes’ if the donor meets eligibility criteria
• Indicate ‘No’ if the donor does not meet eligibility criteria
  

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.