The Most Common and/or Serious Research Audit Findings at IU: What are They? How to Prevent Them?

1. The Most Common and/or Serious Research Audit Findings at IU:What are They?  How to Prevent Them? Christy Yoder, CCRP IUPUI/Clarian Human Subjects Research and HIPAA Auditor

2. Background • I have been auditing both ‘for cause’ and ‘not for cause’ for the IU IRB and Compliance Office since April 2005. • This entails many types of studies across campus, from behavioral studies in nursing to HIV drug trials to pediatric device trials. • Prior to that I worked at the Cancer Center here on campus. I was first a research coordinator and then the Clinical Trials Monitoring Committee Coordinator. • I conduct audits, help sites prepare for audits, and help them respond to audit reports.

3. Who might audit your studies? • Internal Audit —examples would be audits completed by a member of the research team or department staff • Sponsor or Sponsor Designee Audit —drug or device company, someone they hire, or cooperative group • Federal Agency Audit —OHRP, FDA, OCR • Research Compliance (IRB) Audit —me or other agent designated by the IRB

4. Most Common and/or Serious Findings • Finding: Lack of documentation of the consent process • Reference: IUPUI/Clarian Research SOP-Obtaining and Documenting Informed Consent 5.7.3, Written notation should also be made in the medical and/or research source record to document that the consent process occurred. Thus for every consent, there should be a corresponding note to file regarding the process.

5. Possible Preventions • Incorporate notes regarding the consent process into nursing notes, progress notes, etc. • Use a separate template form.

7. Most Common and/or Serious Findings • Finding: Not using the ‘current’ version of the informed consent document. (after amendments or continuing reviews) • Reference: IUPUI SOP for Obtaining and Documenting Informed Consent 5.10, After the IRB reviews and re-approves the consent document(s), it will be “stamped” with a new approval and continuing review due date. This newly stamped consent document becomes the “current” consent document for the study and must be the version to be signed by all future subjects until such time that a revision to it is approved by the IRB.

8. Possible Preventions • Develop tracking methods for consent ‘versions.’ An electronic method accessible to the research team is usually best. • Scanning newest version and posting it for printing in a way that is easily accessible for all who may need it. Eliminate the need to keep multiple copies.

9. Consent Tracking Form Example

10. Most Common and/or Serious Findings • Finding: Source documentation that is not appropriately signed and dated. • Reference: IUPUI SOP for Data Management 5.3.3.3, Case report/data collection forms typically represent the summary or collation of data from the original source documents…While not the original source documents, they may be used as such…and must be signed and dated by the original observer/recorder.

11. Possible Preventions • Create forms with places for signatures and dates when possible. • Conduct internal audits to recognize these deficiencies early in a study to create procedure to prevent them. • Though a little more complex, sometimes it is possible to get one signature for a whole set of data. This can only be utilized when one person is creating the information and it is all on the same date, i.e. a PI assessing adverse event relationships.

12. Most Common and/or Serious Findings • General Finding: Incorrectly completed “HIPAA Form” or most accurately referred to as the ‘Authorization for the Release of Health Information for Research’ form (the authorization)

13. The ‘Authorization’ Form

14. The ‘Authorization’ Form

16. Most Common and/or Serious Findings • Finding: Not notifying IUPUI/Clarian RCA of impending audits. • Reference: IUPUI SOP for Auditing of Research Involving Human Subjects 5.5.2, When an investigator receives notification of an upcoming compliance inspection visit by a regulatory agency, funding agency, or study sponsor, he/she should immediately notify RCA at …

17. Possible Preventions • Ensure that all members of your research team are aware of this requirement. • This notification can help facilitate additional help with preparing for your audit by: 1. Alerting RCA staff so they can ensure they are prepared to react quickly. 2. Allowing an opportunity for me to assist with preparation, if desired.

18. Most Common and/or Serious Findings • Finding: Closure of study or lapse in approvals while study related activities are still ongoing. • Reference: IUPUI SOP for IRB Operations and Study Approval Process 5.10.9, Oversight by the IRB is required as long as investigators are either interacting or intervening with subjects for research purposes, or accessing identifiable information for research purposes.

19. Possible Preventions • Ensure that all of your research team members are aware of this requirement. • Obtain documentation from your sponsor that, among other things, that they recognize and agree that when you close the study with the IRB you will no longer be able to access identifiable information. • Track closely your approval time frame and proactively prevent or address lapses in approval.

20. General Prevention Measures • Know and keep abreast of IUPUI/Clarian Research SOP’s—available at: http://www.iupui.edu/%7Erespoly/human-sop/human-sop-index.htm Auditing of Research Involving Human Subjects Children in Research Collection, Storage, and/or Use of Biological Specimens for Research Conflict of Interest Reporting to the IRB Data Management Emergency Use of and Planned Emergency Research with Investigational Agents or Devices Exempt and expedited New Study Approval Process Handling Humanitarian Use Device Human Subject Identification, Selection, and Recruitment Investigational Device Accountability Investigational Drug Accountability

21. General Prevention Measures SOP’s continued: IRB Operations and Study Approval Process Obtaining and Documenting Informed Consent Pregnant Women, Human Fetuses, Neonates, and Fetal Material in Research Prisoners in Research Reporting Research Personnel Qualifications and Training Responsibilities of Principal Investigators Security and Research Data Student Projects Subject Confidentiality and Privacy Unanticipated Problems Involving Risks to Subjects or Others and Noncompliance • Subscribe to and read the e-newsletter, ‘Research Enterprise’: http://research.iupui.edu • Conduct regular internal audits.

22. General Prevention Measures • Ensure that all members of the research team are educated in research compliance on an ongoing basis. • Keep all documentation related to the research organized, easily accessible, and easy to follow. • PI’s: hire and train responsible and detail oriented research coordinators!!