Pre-HCT Measurable Residual Disease Assessment

*The timeline requirements for this form are as follows:
Assessment Time Frame: Within 45 days prior to the anticipated start of the conditioning regimen.
Submission Time Frame: Within 5 business days of collection.

*This form will only appear in the EDC if the “Specify the disease indication at diagnosis” field on Recipient Disease form is answered ALL, AML, Other Acute Leukemia, CLL and Other Leukemia or Lymphoma.

Was MRD assessment performed?:
Report whether an MRD assessment was performed as “Yes” or “No”.

If answered Yes, complete the questions below regarding the MRD assessment.

Per protocol an MRD assessment is required to be completed at screening. If this field is answered No a protocol deviation should be logged in the EDC.

Date MRD assessment performed:
This field will only appear in the EDC if “Was MRD assessment performed?” is answered Yes. Enter the date the assessment 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 an MRD assessment is required to be completed within 45 days prior to the anticipated start of the conditioning regimen. If the MRD assessment date entered is outside of those parameters a protocol deviation should be logged in the EDC.

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

Method of MRD assessment:
This field will only appear in the EDC if “Was MRD assessment performed?” is answered Yes. Indicate the method of assessment by selecting “Flow Cytometry”, “Next generation sequencing”, or “PCR”. If the MRD method of assessment is not available in the list, report “Other, specify” and specify the method of assessment in the text box (up to 200 characters).

MRD result:
This field will only appear in the EDC if “Was MRD assessment performed?” is answered Yes. Indicate the result of the MRD assessment by selecting “Positive” or “Negative”, as determined by physician.

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