Attachment 14_PHS Human Subjects and Clinical Trials Information Form.docx
DOCX document 339 KB Posted
- Solicitation number
- HHS-NIH-NIAID-BAA2025-1
About this file
This is a PHS Human Subjects and Clinical Trials Information Form template used for clinical research studies. The form is structured in five main sections: Basic Information, Study Population Characteristics, Protection and Monitoring Plans, Protocol Synopsis, and Clinical Trial-related Attachments.
The template requires details about study titles, exemption status, clinical trial classification, participant demographics, inclusion/enrollment reporting, protection protocols, study design, outcome measures, and FDA regulations. It includes fields for documenting racial and ethnic enrollment data, timeline planning, data monitoring, and intervention details. This is a standard form template that does not contain any specific study information or completed data - it only shows the structure and required fields that would need to be completed for human subjects research.
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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 8Yes 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 Add New Condition
2.2. Eligibility Criteria
2.3. Age Limits Minimum Age Maximum Age
2.3.a. Inclusion of Individuals Across the LifespanView Attachment Add Attachment Delete Attachment
2.4. Inclusion of Women and MinoritiesView Attachment
2.5. Recruitment and Retention PlanView Attachment
2.6. Recruitment Status
2.7. Study TimelineView Attachment
2.8. Enrollment of First Participant
2.9. Inclusion Enrollment Report(s)
Add Inclusion Enrollment Report
Inclusion Enrollment Report
OMB Number: 0925-0770 Expiration Date: 09/30/2024Remove Inclusion Enrollment Report
1. * Inclusion Enrollment Report Title
2. * Using an Existing Dataset or ResourceYes No
3. * Enrollment Location TypeDomestic Foreign
4. Enrollment Country(ies)x Add New Country
5. Enrollment Location(s)
6. Comments
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
Female
Male Unknown/ Not Reported
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 Reported
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 SubjectsView Attachment
Add Attachment Delete Attachment
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/ASingle IRB plan attachment
Add Attachment Delete Attachment View Attachment
3.3. Data and Safety Monitoring Plan
Add Attachment Delete 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
Section 4 - Protocol Synopsis
4.1. Study Design
4.1.a. Detailed Description
4.1.b. Primary Purpose
4.1.c. Interventions x Intervention Type
Name
Description
Add New Intervention
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
4.2. Outcome Measures
x Name
Type
Time Frame
Brief Description
Add New Outcome
4.3. Statistical Design and PowerView Attachment
Add Attachment Delete Attachment
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) statusView Attachment Add Attachment Delete Attachment
4.6. Is this an applicable clinical trial under FDAAA? Yes No
4.7. Dissemination PlanView Attachment
Add Attachment Delete Attachment
Section 5 - Other Clinical Trial-related Attachments
5.1. Other Clinical Trial-related AttachmentsView Attachments Add Attachments Delete Attachments image1.png image2.png image3.png image4.png
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