APPENDIX A.2 HumanSubjectStudy_3_0-V3.0 Form H 5-23 (3).pdf
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This document is an Inclusion Enrollment Report for a human subjects research study. It contains information about the planned and actual enrollment of participants, including their racial and ethnic categories, gender, and other demographic details. The study is focused on certain conditions or research areas, and has eligibility criteria regarding participants' age range. The document includes sections on protection and monitoring plans, study design and outcomes, and other clinical trial-related attachments. However, it does not provide details about any specific product or service being procured through a federal contract opportunity.
The related federal contract opportunity is a solicitation for Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) Phase I and/or Direct to Phase II or Fast Track contracts in support of the Advanced Research Projects Agency for Health (ARPA-H)'s FY2024 program areas. The solicitation covers topics such as ambulatory edema monitors, predictive language models for cognitive disability adaptive communication tools, cell and gene therapy process analytical technology, wearable cell sorting and gene delivery systems, precision brain targeting, personalized food as medicine, inner ear imaging devices, and advanced blood pressure monitoring technologies. Proposals are due by July 15, 2024, and the contracting agency is the General Services Administration's Federal Acquisition Service.
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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
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|<< 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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Add New Outcome
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