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Study Protocol Number *

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Your Progress (34 fields)
Protocol Information
1
Study Protocol Number
2
Protocol Version Number
Investigator Information
3
Principal Investigator Name
4
Principal Investigator Contact Info...
5
Sponsor Name and Address
Study Overview
6
Study Abstract
7
Background and Significance
8
Specific Aims and Hypotheses
Study Design
9
Research Plan
Subject Characteristics
10
Subject Age Range
11
Subject Demographics
12
Inclusion Criteria
13
Exclusion Criteria
14
Expected Sample Size
Interventions and Endpoints
15
Study Endpoints
16
Intervention / Treatment Descriptio...
Data Management
17
Data Collection Methods
18
Data Analysis Plan
19
Monitoring for Subject Compliance
20
Data Storage and Confidentiality
21
Carle-specific REDCap Information
Subject Safety
22
Transition from Research Participat...
23
Risk/Benefit Assessment
24
Unanticipated Problems Reporting Pl...
25
Severe Adverse Event Reporting
Recruitment and Consent
26
Subject Identification and Recruitm...
27
Consent/Assent Process
28
Vulnerable Populations
29
Subject Costs
30
Subject Compensation
Outcomes and Dissemination
31
Expected Results and Impact
32
Publication Plan / Future Direction...
33
Literature Cited
34
Study Budget
Validation Status