Att_5_PHS_Human_Subjects_and_Clinical_Trials_Information_Form.pdf
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- RADx Award Management
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This document is a PHS Human Subjects and Clinical Trials Information form (OMB Number: 0925-0001, expiration date 01/31/2026) used to record study information for human subjects research and clinical trials.
Section 1 requires basic study information including a unique study title, determination of federal regulation exemption status (with exemption numbers 1-8), and completion of a clinical trial questionnaire that assesses whether the study involves human participants prospectively assigned to an intervention designed to evaluate health-related biomedical or behavioral outcomes. A ClinicalTrials.gov identifier must be provided if applicable. Section 2 addresses study population characteristics, requiring documentation of conditions or focus, eligibility criteria, age limits (minimum and maximum), inclusion of individuals across the lifespan, inclusion of women and minorities, recruitment and retention plans, recruitment status, study timeline, enrollment of first participant date, and inclusion enrollment reports. The inclusion enrollment reports require a title, specification of whether an existing dataset or resource is used, designation of enrollment location type (domestic or foreign), enumeration of enrollment countries and locations, and comments. Demographic data must be recorded by racial categories (American Indian/Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, White, More than One Race) and ethnic categories (Not Hispanic or Latino, Hispanic or Latino, Unknown/Not Reported), disaggregated by gender, in both planned and cumulative actual enrollment tables. Section 3 requires documentation of human subjects protection measures, specification of multi-site protocols, single IRB plans, and data and safety monitoring plans, including whether a Data and Safety Monitoring Board will be appointed. Section 4 comprises the protocol synopsis, requiring study design details, primary purpose, intervention types with names and descriptions, study phase designation, intervention model, masking specifications, allocation methods, outcome measures with time frames and descriptions, statistical design and power analysis, subject participation duration, FDA-regulated intervention status and IND/IDE information, FDAAA applicability determination, and dissemination plans. Section 5 provides space for other clinical trial-related attachments.
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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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View Attachment Add Attachment Delete Attachment x Add New Condition
Add Inclusion Enrollment Report
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 Add New Country
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
< Previous Report Next Report >
|<< First Report Delete Report Last Report >>|
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
Single IRB plan attachment Add Attachment Delete Attachment View Attachment
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
Add New Intervention
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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