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 folders 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 the empty PBSC product bag submitted for TCR diversity:
The empty bag or syringe from which the stem cell product was infused will be collected and shipped per the study lab manual. Report whether the empty product bag 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 the empty PBSC product bag submitted for TCR diversity” is answered No. Please describe the reason the empty product bag was not submitted in this free textbox (up to 200 characters).
CCG v1.0 | CRF v1.3
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