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Investigator Toolkit: Additional Regulatory Resources

Investigator Toolkit: Additional Regulatory Resources

Welcome to the CTSI-CN Investigator Toolkit: Additional Regulatory Resources. The purpose of this toolkit is to provide investigators and their study teams with the various resources needed for the successful preparation and submission of a research proposal. Topics include study design, preparation of the written protocol and consent documents, submission to the IRB, and the reporting of unanticipated problems and adverse events.

The Investigator Toolkit is a work in progress. Please check back frequently for additional content. You are also invited to send your comments about the usefulness of the toolkit and make suggestions about additional resources you would like to be included.

1) Contact Us

2) Human Subjects Research Training

3) Collaborative Research

4) Investigator and Research Staff Responsibilities

5) Study Design

  • 5.1. Quality Improvement Activities
  • 5.2. Retrospective Medical Record and Database Reviews
  • 5.3. Collection and Use of Biological Specimens
  • 5.4. Registries Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User's Guide 2nd ed (.pdf). (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. d/b/a Outcome] under Contract No.HHSA29020050035I TO3.) AHRQ Publication No.10-EHC049. Rockville, MD: Agency for Healthcare Research and Quality. September 2010.
  • 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

8) Informed Consent/Parental Permission and Assent

9) Subject Privacy and Data Confidentiality

10) Data and Safety Monitoring

11) Unanticipated Problems and Adverse Events

12) Responsible Conduct of Research

  • 12.1. In "The Lab: Avoiding Research Misconduct," you become the lead characters in an interactive movie and make decisions about integrity in research that can have long-term consequences. The simulation addresses Responsible Conduct of Research topics such as avoiding research misconduct, mentorship responsibilities, handling of data, responsible authorship, and questionable research practices.

13) Maintaining Research Records

14) Additional Resources


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