Attachment 8: Inclusion Enrollment Report

Study Record: PHS Human Subjects and Clinical Trials Information OMB Number: 0925-0001
Expiration Date: 01/31/2026

* Always required field

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

Yes

1.2. * Is this Study Exempt from Federal Regulations?

1.3. Exemption Number

No

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

x
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2.2. Eligibility Criteria

2.3. Age Limits

Minimum Age

Maximum Age

2.3.a. Inclusion of Individuals Across the Lifespan

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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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2.6. Recruitment Status

2.7. Study Timeline

2.8. Enrollment of First Participant

2.9. Inclusion Enrollment Report(s)

Add Inclusion Enrollment Report

OMB Number: 0925-0770
Expiration Date: 09/30/2024

Inclusion Enrollment Report

1. * Inclusion Enrollment Report Title

2. * Using an Existing Dataset or Resource

3. * Enrollment Location Type

4. Enrollment Country(ies)

x
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5. Enrollment Location(s)

6. Comments

Yes
Domestic

No
Foreign

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Planned
Ethnic Categories
Racial Categories

Not Hispanic or Latino
Female

Total

Hispanic or Latino

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)

Ethnic Categories
Racial Categories

Not Hispanic or Latino
Female

Hispanic or Latino

Unknown/
Not
Reported

Male

Female

Unknown/
Not
Reported

Male

Total

Unknown/Not Reported Ethnicity
Female

Unknown/
Not
Reported

Male

American Indian/
Alaska Native

Asian

Native Hawaiian or
Other Pacific Islander

Black or African
American

White

More than One Race

Unknown or Not
Reported

Total

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