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pdfStudy 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 Type | application/pdf |
| File Title | Axure Document |
| Author | romanl |
| File Modified | 2021-06-12 |
| File Created | 2019-12-23 |