Initial Review Application Help

• Basic Study Information
• PI Information
  
• Request to Serve as PI
• Type of Application
• Funding Information
  
• Clinicaltrials.gov Registration

Section 2

• Protocol Development Activities (PDA)
  

Section 4

• Study Summary
  
• Special Considerations and Procedures
  

Section 5

• Research Design and Procedures
  

Section 6

• Risks and Benefits: General
• Risks: Physical Interventions
  
• Risk/Benefit Analysis
  

Section 7

• Subject Population: General
• Subject Population: Vulnerable Group Checklist
  

Section 8

• Subject Identification and Recruitment: General
  
• Subject Recruitment: Continued
• Compensation

Section 9

• Privacy and Confidentiality
  

Section 10

• Informed Consent: General
• Waiver of Informed Consent
  
• Alteration of Informed Consent Process
• Waiver of Signed Consent
• Informed Consent: Overview
• Informed Consent: Impaired Decision-Making Capacity
• Informed Consent: Non-English Speakers
  

Section 11

• HIPAA: General
• HIPAA Authorization
  
• Request for Waiver, Altered, or Partial Waiver of Authorization (Q5.2.1)
• Limited Data Set
  

Section 12

• Audio Recordings/Video Recordings/Photographs
  
• Audio Recordings
  

Section 14

• Collection and/or Use of Biological Specimens

Section 15

• Deception
  

Section 21

• Interviews, Focus Groups, Surveys, Questionnaires, Assessments
• Cognitive and Psychological Assessments (Q2.3.1)
  
• Interviews, Focus Groups, Surveys, Questionnaires, Assessments: Continued (Q3.1.2)
  

Section 26

• Research Activities Occurring in an Educational Setting (Q1.2 and 1.6)
  

Section 27

• Review of Records/Data/Images (Q1.5)
  

Section 30

• Community Based Research
  

Section 31

• Use of New Media
  

Section 33

• Final Page