Att_8_Inclusion_Enrollment_Report.pdf
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- Solicitation number
- 75N98026R00074
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This is a PHS Human Subjects and Clinical Trials Information form (OMB Number: 0925-0001, expiration 01/31/2026) used to document human subjects research and clinical trial data for submission to federal agencies.
The form comprises five main sections. Section 1 captures basic study information including a unique study title, exemption status from federal regulations, and a clinical trial questionnaire with four yes/no questions to determine if the study meets the definition of a clinical trial (involving human participants, prospective intervention assignment, evaluation of intervention effects, and health-related outcomes). Section 2 documents study population characteristics such as conditions studied, eligibility criteria, age limits, inclusion of women and minorities, recruitment and retention plans, recruitment status, study timeline, and enrollment data broken down by race, ethnicity, and gender in both planned and cumulative actual enrollment tables. Section 3 addresses protection and monitoring plans, including human subjects protection measures, multi-site study coordination through single IRB arrangements, data and safety monitoring plans, and study team structure. Section 4 provides the protocol synopsis with detailed study design description, primary purpose, intervention types and descriptions, study phase designation, intervention models, masking strategies, allocation methods, outcome measures with time frames, statistical design and power analysis, subject participation duration, FDA-regulated intervention status, and dissemination plans. Section 5 allows for attachment of additional clinical trial-related supporting documentation. The form includes an embedded Inclusion Enrollment Report (OMB Number: 0925-0770) for tracking enrollment by location type and country.
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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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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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