STUDY CONCEPT FORM Principal Investigator: Contact Information: Institution: Title of Protocol: Preliminary Data and Background: Primary Hypothesis: Secondary Hypothesis(es): Patient Population (include type of disease(s), age range, and basic eligibility criteria): Treatment Plan (include type of transplant(s), conditioning therapy, GVHD prophylaxis and experimental treatment agent if applicable): Primary Outcome: Secondary Outcome(s): Potential laboratory/QOL/Ancillary Studies: Basic Study Design: Phase I II III Other: Blinded Yes No Randomized Yes No Accrual Period: Follow-up Period: Sample Size (provide details of computation, i.e. detectable difference, power and size):
STUDY CONCEPT FORM Principal Investigator: Contact Information: Institution: Title of Protocol: Preliminary Data and Background: Primary Hypothesis: Secondary Hypothesis(es): Patient Population (include type of disease(s), age range, and basic eligibility criteria): Treatment Plan (include type of transplant(s), conditioning therapy, GVHD prophylaxis and experimental treatment agent if applicable): Primary Outcome: Secondary Outcome(s): Potential laboratory/QOL/Ancillary Studies: Basic Study Design: Phase I II III Other: Blinded Yes No Randomized Yes No Accrual Period: Follow-up Period: Sample Size (provide details of computation, i.e. detectable difference, power and size):
study_concept_form_v3.docx