Recipient HLA Typing

*The timeline requirements for this form are as follows:
Assessment Time Frame: Screening occurs up to 45 days prior to the anticipated start of the conditioning regimen. May be performed earlier than 45 days prior to the start of the conditioning regimen.
Submission Time Frame: Within 5 business days of collection.

Date of high-resolution HLA typing of recipient:
Enter the date the high-resolution HLA typing for the recipient was completed. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used. Date should be date of testing, not date of collection (if dates are different).

Per protocol high-resolution HLA typing is required at Screening. If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.

If the date entered is a future date, a query will appear in the EDC.

Date of high-resolution HLA typing of donor:
Enter the date the high-resolution HLA typing for the donor was completed. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used. Date should be date of testing, not date of collection (if dates are different).

Per protocol high-resolution HLA typing is required at Screening. If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.

If the date entered is a future date, a query will appear in the EDC.

Date of DSA testing:
Enter the date the DSA testing was completed. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.

Per protocol DSA testing is required at Screening. If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC. Date should be date of testing, not date of collection (if dates are different).

If the date entered is a future date, a query will appear in the EDC.

HLA match level (HLA matching at loci A, B, C, and DRB1):
Indicate the match level based on high-resolution testing for loci A, B, C, DRB1, DPB1 and DQB1 from the available options. Match level must be greater than or equal to 4/8, and less than 8/8.

Per protocol high-resolution HLA typing is required at Screening. If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.

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