- Subjects must be consented and enrolled in the Veeva EDC prior to conducting study-specific evaluations/procedures/tests/interventions (i.e., evaluations/procedures/tests/interventions that are beyond standard of care and directly required per protocol).
- Subjects having documented informed consent to participate in research and meeting all eligibility criteria for the study should be enrolled in the Veeva EDC prior to HCT date (for lead-in phase) or randomization to control arm or one of the open intervention arms (for randomization phase).
CCG v1.0 | CRF v1.3
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