This form will only appear in the EDC if the “Has the disease relapsed or progressed since last reported for the study” field is answered Yes, and “Were relapse research samples collected prior to initiation of therapy to treat relapse?” is answered Yes on Follow-Up Assessments form (Day 28, Day 56, Day 100, Day 180, Day 270, Day 365).
Research sample collection is only required of participants at select centers. Subjects must consent to participate in the research sample collection, if collection is required at your center. Please contact the ACCELERATE study team (ACCELERATE@nmdp.org) if you are unsure whether your site is required to collect research samples. Failure to collect any samples will constitute a protocol deviation. Refer to Appendix A – RESEARCH SAMPLE COLLECTION section or the study lab manual for more information.
Was a whole blood sample submitted for PBMC & Plasma (EDTA)?:
A whole blood sample for PBMC & Plasma will be collected and shipped per the study lab manual. Report whether the whole blood sample was submitted as Yes or No.
If “No”, a protocol deviation should be logged in the EDC.
If no, specify reason:
This field will only appear in the EDC if “Was a whole blood sample submitted for PBMC & Plasma (EDTA)?” is answered No. Please describe the reason the whole blood sample for PBMC & Plasma was not submitted in this free textbox (up to 200 characters).
Was a sample submitted for Whole Blood Processing?:
A sample for Whole Blood Processing will be collected and shipped per the study lab manual. Report whether the whole blood sample was submitted as Yes or No.
If “No”, a protocol deviation should be logged in the EDC.
If no, specify reason:
This field will only appear in the EDC if “Was a sample submitted for Whole Blood Processing?” is answered No. Please describe the reason the whole blood sample for Whole Blood Processing was not submitted in this free textbox (up to 200 characters).
Was a whole blood sample submitted for PAXgene RNA?:
A whole blood sample for PAXgene RNA will be collected and shipped per the study lab manual. Report whether the whole blood sample was submitted as Yes or No.
If “No”, a protocol deviation should be logged in the EDC.
If no, specify reason:
This field will only appear in the EDC if “Was a whole blood sample submitted for PAXgene RNA?” is answered No. Please describe the reason the whole blood sample for PAXgene RNA was not submitted in this free textbox (up to 200 characters).
Was a whole blood sample submitted for Plasma (Streck)?:
A whole blood sample for Plasma (Streck) will be collected and shipped per the study lab manual. Report whether the whole blood sample was submitted as Yes or No.
If “No”, a protocol deviation should be logged in the EDC.
If no, specify reason:
This field will only appear in the EDC if “Was a whole blood sample submitted for Plasma (Streck)?” is answered No. Please describe the reason the whole blood sample for Plasma (Streck) was not submitted in this free textbox (up to 200 characters).
Was a whole blood sample submitted for LOH Evaluation Testing (NaHep)?:
A whole blood sample for loss of heterozygosity (LOH) Evaluation Testing (NaHep) will be collected and shipped per the study lab manual. Report whether the whole blood sample was submitted as Yes or No.
If “No”, a protocol deviation should be logged in the EDC.
If no, specify reason:
This field will only appear in the EDC if “Was a whole blood sample submitted for LOH Evaluation Testing (NaHep)?” is answered No. Please describe the reason whole blood sample for LOH Evaluation Testing (NaHep) was not submitted in this free textbox (up to 200 characters).
Was a buccal swab sample submitted for loss of heterozygosity (LOH) germline testing?:
A buccal swab for loss of heterozygosity (LOH) germline testing will be collected and shipped per the study lab manual. Report whether the buccal swab was submitted as Yes or No.
If “No”, a protocol deviation should be logged in the EDC.
If no, specify reason:
This field will only appear in the EDC if “Was a buccal swab sample submitted for loss of heterozygosity (LOH) germline testing?” is answered No. Please describe the reason the buccal swab for loss of heterozygosity (LOH) germline testing was not submitted in this free textbox (up to 200 characters).
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