APPENDIX A.2 HumanSubjectStudy_3_0-V3.0 Form H 5-23 (1).pdf

* Always required field

Study Record: PHS Human Subjects and Clinical Trials Information

OMB Number: 0925-0001

Expiration Date: 01/31/2026

Section 1 - Basic Information

1.1. * Study Title (each study title must be unique)

1.2. * Is this Study Exempt from Federal Regulations?

1.3. Exemption Number

1 2 3 4 5 6 7 8

1.4. * Clinical Trial Questionnaire

If the answers to all four questions below are yes, this study meets the definition of a Clinical Trial.

1.4.a. Does the study involve human participants? Yes No

1.4.b. Are the participants prospectively assigned to an intervention? Yes No

1.4.c. Is the study designed to evaluate the effect 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? Yes No

1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable

Section 2 - Study Population Characteristics

2.1. Conditions or Focus of Study

2.2. Eligibility Criteria

2.3. Age Limits Minimum Age Maximum Age

2.3.a. Inclusion of Individuals Across the Lifespan

2.4. Inclusion of Women and Minorities

2.5. Recruitment and Retention Plan

2.6. Recruitment Status

2.7. Study Timeline

2.8. Enrollment of First Participant

2.9. Inclusion Enrollment Report(s)

Yes No

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Inclusion Enrollment Report

OMB Number: 0925-0770

Expiration Date: 09/30/2024

1. * Inclusion Enrollment Report Title

2. * Using an Existing Dataset or Resource

3. * Enrollment Location Type

4. Enrollment Country(ies)

5. Enrollment Location(s)

6. Comments

Remove Inclusion Enrollment Report

Yes No

Domestic Foreign x

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Planned

Racial Categories

Ethnic Categories

Not Hispanic or Latino Hispanic or Latino Total

Female Male Female Male

American Indian/

Alaska Native

Asian

Native Hawaiian or

Other Pacific Islander

Black or African

American

White

More than One Race

Total

Cumulative (Actual)

Racial Categories

Ethnic Categories

Not Hispanic or Latino Hispanic or Latino Unknown/Not Reported Ethnicity Total

Female

Male

Unknown/

Not

Reported

American Indian/

Alaska Native

Asian

Native Hawaiian or

Other Pacific Islander

Black or African

American

White

More than One Race

Unknown or Not

Total

Report 1 of 1

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Section 3 - Protection and Monitoring Plans

3.1. Protection of Human Subjects

3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

Yes No N/A

4.1. Study Design

4.1.a. Detailed Description

4.1.b. Primary Purpose

4.1.c. Interventions x Intervention Type

Name

Description

4.1.d. Study Phase

Is this an NIH-defined Phase III clinical trial? Yes No

4.1.e. Intervention Model

4.1.f. Masking

Yes

Participant

No

Care Provider Investigator Outcomes Assessor

4.1.g. Allocation

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3.3. Data and Safety Monitoring Plan Add Attachment Delete Attachment View Attachment

3.4. Will a Data and Safety Monitoring Board be appointed for this study?

Yes No

3.5. Overall Structure of the Study Team Add Attachment Delete Attachment View Attachment

Section 4 - Protocol Synopsis

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4.2. Outcome Measures

x Name

Type

Time Frame

Brief Description

4.3. Statistical Design and Power

4.4. Subject Participation Duration

4.5. Will the study use an FDA-regulated intervention? Yes No

4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational

Device Exemption (IDE) status

4.6. Is this an applicable clinical trial under FDAAA? Yes No

4.7. Dissemination Plan

Section 5 - Other Clinical Trial-related Attachments

5.1. Other Clinical Trial-related Attachments

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