APPENDIX A.2 HumanSubjectStudy_3_0-V3.0 Form H 5-23.pdf
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- Solicitation number
- 75N91024R00006
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This document contains a Small Business Innovation Research (SBIR) Contract Solicitation from the Advanced Research Projects Agency for Health (ARPA-H) inviting proposals in six technology areas. Proposals are due by February 22, 2024 and must address one of the following: inexpensive plant-based manufacturing of viral vectors for gene therapies; a LymphoLab ProDiscover Kit; continuous monitoring of vascular health using smart biomimetic implantables; a personalized medicine platform for predicting response to immunotherapy; fully autonomous neonatal echocardiography for diagnosis of critical congenital heart disease; or improving identity and access management with clinical context. Questions are due by February 15, 2024 and must be sent to the ARPA-H SBIR/STTR Program mailbox. The solicitation is seeking research and development proposals from small business concerns that can conduct R&D and commercialize results to contribute to ARPA-H's mission needs and SBIR program objectives. The soliciting agency is the Department of Health and Human Services National Institutes of Health National Cancer Institute.
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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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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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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
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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
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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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