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PHS Applications and Pre-award Related Reporting (OD)

Attachment 5F_HumanSubjectStudy_3_0-V3.0_Sections 1-6

398/424 PHS Human Subjects and Clinical Trial Information

OMB: 0925-0001

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Study Record: PHS Human Subjects and Clinical Trials Information
OMB Number: 0925-0001 and 0925-0002
Expiration Date: 02/28/2023
• 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

(NEW) OMB Number: 0925-XXXX
Expiration Date: 02/28/2023

4. Enrollment Country(ies)
X

5. Enrollment Location(s)

6. Comments

Planned
Ethnic Categories
Racial Categories

Not Hispanic or Latino

American Indian / Alaska Native

Hispanic or Latino

Male

Female

Female

Total

Male

0
0

0

0

0

0

0

0

0

0

0

0

0

0

0

Black or African American

0

0

0

0

0

White

0

0

0

0

0

More than one Race

0

0

0

0

0

Total

0

0

0

0

0

Asian
Native Hawaiian or Other Pacific
Islander

Cumulative (Actual)
Ethnic Categories
Racial Categories

Not Hispanic or Latino

Unknown/
Not Reoorted Ethnicitv
Unknown I
Unknown I
Female Male
Not Reported
Not Reported

Hispanic or Latino

Total

Female

Male

Unknown I
Not Reported

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

American Indian/
Alaska Native
Asian
Native Hawaiian or Other
Pacific Islander
Black or African American
White
More than One Race

Female

Male

Section 3 - Protection and Monitoring Plans
3.1. Protection of Human Subjects

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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
ON/A

□

Single IRB plan attachment

3.3. Data and Safety Monitoring Plan

□

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File Typeapplication/pdf
File TitleAxure Document
Authorromanl
File Modified2024-07-05
File Created2024-07-05

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