Attachment_9_Human_Subject_and_Clinical_Trials_Info_Form.pdf
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- Attached to
- Clinical Support Services for NINDS, Stroke Branch Federal contract opportunity
- Solicitation number
- 75N95024R00106
About this file
This document is a Study Record: PHS Human Subjects and Clinical Trials Information form related to a federal contract opportunity for Clinical Support Services for the Research Efforts of the NINDS, Stroke Branch.
The form provides detailed information about the proposed clinical trial, including the study title, whether it is exempt from federal regulations, and if it meets the definition of a clinical trial. It outlines the study population characteristics, such as the conditions or focus of the study, eligibility criteria, age limits, inclusion of women and minorities, and recruitment and retention plans. The form also covers protection and monitoring plans, the study design and protocol synopsis, including outcome measures, statistical design, subject participation duration, and whether an FDA-regulated intervention will be used. Additional attachments may be provided for the single IRB plan, data and safety monitoring plan, and overall study team structure.
The related federal contract opportunity is for Clinical Support Services for the NINDS, Stroke Branch, with a Solicitation Number of 75N95024R00106, issued by the Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse.
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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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|<< 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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