Source: https://www.ctsicn.org/investigator-toolkit-reg
Timestamp: 2019-09-19 21:23:13
Document Index: 215901409

Matched Legal Cases: ['art 46', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 6', 'art 7', 'art 8', 'art 9', 'art 10', 'art 11']

Research Toolkits ›
2) Human Subjects Research Training
2.1. GWU CITI Registration and Training Instructions.pdf
2.2. GWU CITI Instructions for Refresher Courses and Completion Reports.pdf
2.3. CITI Training in Human Subjects Research Instructions for New Users (.pdf)
2.4. CITI Training in Human Subjects Research Instructions for Registered Users (.pdf)
3) Collaborative Research
4) Investigator and Research Staff Responsibilities
5) Study Design
5.5. Is an Activity Research Involving Human Subjects Covered by 45 CFR Part 46? Decision Chart 1.pdf
5.6. Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.101(b)? Decision Chart 2.pdf
5.7. Does Exemption 45 CFR 46.101(b)(1) Apply? (Educational Settings) Decision Chart 3.pdf
5.8. Does Exemption 45 CFR 46.101(b)(2) or (b)(3) Apply? (Tests, Surveys, Interviews, Public Behavior Observation) Decision Chart 4.pdf
5.9. Does Exemption 45 CFR 46.101(b)(4) Apply? (Existing Data Documents and Specimens) Decision Chart 5.pdf
5.10. Does Exemption 45 CFR 46.101(b)(5) Apply? (Public Benefit or Service Programs) Decision Chart 6.pdf
5.11. Does Exemption 45 CFR 46.101(b)(6) Apply? (Food Taste and Acceptance Studies) Decision Chart 7.pdf
5.12. May IRB Review be Done by Expedited Procedures Under 45 CFR 46.110? Decision Chart 8.pdf
5.13. Can Continuing Review be Done by Expedited Procedures Under 45 CFR 46.110? Decision Chart 9.pdf
5.14. Can Informed Consent be Waived or Consent Elements be Altered Under 45 CFR 46.116(c) or (d)? Decision Chart 10.pdf
5.15. May Documentation of Informed Consent be Waived Under 45 CFR 46.117(c)? Decision Chart 11.pdf
6) Vulnerable Populations
7) IRB Submission Process
7.4. Implementation of NIH Single IRB Policy at Children's National
8) Informed Consent/Parental Permission and Assent
9) Subject Privacy and Data Confidentiality
​​10.1.Data and Safety Monitoring (Children's National policy and procedure 08.09(P) (.pdf)
11) Unanticipated Problems and Adverse Events
12) Responsible Conduct of Research
13) Maintaining Research Records
​​13.1 Purdue Data Management Plan Self Assessment (.pdf)
14) Additional Resources