18 HSCT Sections 1-6

Study Record: PHS Human Subjects and Clinical Trials Information
OMB Number: 0925-0001 and 0925-0002
Expiration Date: 03/31/2020
• Always Required field

Section 1 - Basic Information
1.1 • Study Title (each study title must be unique)

1.2 • Is this Study Exempt from Federal Regulations? D Yes

D No

01 02 03 04 05 06 07

1.3 Exemption Number

08

1.4 *Clinical Trial Questionnaire
If the answers to all four questions are yes, this study meets the definition of a Clinical Trial.
1.4.a. Does the study involve human participants?

D Yes

D No

1.4.b. Are the participants prospectively assigned to an intervention?

D Yes

D No

1.4.c. Is the study designed to evaluate the effectiveness of the intervention on the participants?

□ Yes

□ No

1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

D Yes

D No

1.5 Provide the Clinical Trials.gov Identifier (eg. NCT87654321) for this trial, if applicable

Section 2 - Study Population Characteristics
C::::�s_t_u_d_y
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2.2 Eligibility Criteria

2.3 Age Limits

..l

Minimum Age

2.3.a. Inclusion of Individuals Across the Lifespan

Maximim Age

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2.4 Inclusion of Women and Minorities

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2.5 Recruitment and Retention Plan

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II
II
II

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II
II
II

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2.6. Recruitment Status
2.7. Study Timeline

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2.8. Enrollment of First Participant
2.9. Inclusion Enrollment Report(s)

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Inclusion Enrollment Report
1. • Inclusion Enrollment Report Title
2. • Using an Existing Dataset or Resource

OYes

ONo

3. • Enrollment Location Tvoe

D Domestic

D Foreian

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