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Supporting Education and QI in Research (SEQuR)

Investigator Manual

 

Investigator Manual in PDF Format

1. What is the Purpose of the Investigator Manual?

2. What is the Human Research Protection Program?

3. What is Human Research?

4. What are some of the things that I have to consider before submitting an application to the IRB?

5. What is the Turnaround Time for an IRB Application?

6. What Type of Human Research meets the Criteria for Exemption?

7. What Training do Investigators and Study Staff Need to Conduct Human Research?

8. What Financial Interests and Potential or Actual Conflict of Interests Must be Reported to the IRB?

9. Who Needs to Review My Research Prior to IRB Submission?

10. How to Write a Research Plan for IRB Purposes?

11.Do I Need to Obtain Informed Consent?

12. How Do I Create a Consent/Assent Document?

13. Do I Have to Register my Human Research on clinicaltrials.gov?

14. Can I Advertise for Recruitment of Research Participants?

15. How Do I Put Together a Budget?

16. What is the Process for Review and Execution of a Clinical Disclosure Agreements or a Clinical Study Contract Agreement?

17. How to Submit New Non-exempt Human Research to the IRB?

18. How Does the IRB Decide to Approve Human Research?

19. What Will  Happen after IRB Review?

20. What are the Investigator's Obligations after IRB approval?

21. How to Document Informed Consent?

22. How to Submit protocol Modifications/Changes with an Amendment?

23. How to Submit an Annual Progress Report for Continuing Review?

24. How to Get Help for an IRB Submission?

25. Are There any Services Available to Assist Investigators with Ensuring Regulatory Compliance?

26. How Do I Report Unanticipated Problems Involving Risks to Participants or Future Participants and Protocol Deviations?

27. How to Close Out a Study?

28. How Long Records  should be Kept?

29. HIPAA

30. What Happens to Non-Compliance?

31. What Are Sponsor Responsibilities?

32. How to Get Additional Information and Answers to Questions?

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