This form is required at the timepoints listed above if your site is a research sample collection center. This form will only come due in Day 28-Day 365 forms when relapse / progression is not reported on the applicable follow-up form, OR relapse / progression is reported but “Were relapse research samples collected prior to initiation of therapy to treat relapse?” on the follow-up form is answered No.
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 an Immune Reconstitution sample submitted?:
An Immune Reconstitution sample will be collected and shipped per the study lab manual. Report whether the Immune Reconstitution 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 an Immune Reconstitution sample submitted?” is answered No. Please describe the reason an Immune Reconstitution sample 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).
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