Tracking Number:
Funding Opportunity Number:
Received Date:
Section 4 - Protocol Synopsis (Study )
4.1. Study Design
2
4.1.a. Detailed Description
3
18
5
43
4.1.b. Primary Purpose
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2
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4.1.c. Interventions
18
2
Type
Name
Description
4.1.d. Study Phase
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2
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Is this an NIH-defined Phase III Clinical Trial?
4.1.e. Intervention Model
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2
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4.1.f. Masking
Participant
Care Provider
Investigator
Outcomes Assessor
4.1.g. Allocation
4.2. Outcome Measures
2
Type
Name
Time Frame
Brief Description
25
25
25
40
4.3. Statistical Design and Power
3
2
4.4. Subject Participation Duration
3
2
4.5. Will the study use an FDA-regulated intervention?
4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status
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2
4.6. Is this an applicable clinical trial under FDAAA?
4.6. Is this an applicable clinical trial under FDAAA? (SEE SECTION 6.6)
4.7. Dissemination Plan
❏
✔
Yes
Y: Yes
No
N: No
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