1. Office of Human Research (OHR) Quality Improvement Program Patrick Herbison Heather Krupinski

2. Quality Improvement Program The Quality Improvement Program is a function of the Office of Human Research and involves the following activities which will be covered in this presentation: Investigator Site Audits Essential Documentation Binders Compliance Help Policies and Forms Website and Announcements Consent Observations

3. Investigator Site Audits For an investigator site audit, OHR will work with you to review the study records and then provide recommended actions if needed. Why are Audits Done? To Demonstrate IRB Oversight of Studies Help Study Teams with Their Studies Types of Audits Random – A study is randomly selected. For Cause – A specific event triggers an audit. Study Team Request – A study team can request an audit (e.g. In preparation for an FDA inspection.

4. What is Reviewed During an Investigator Site Audit? Study Personnel Lists Documentation of IRB Submissions Consent Patient Eligibility SAE and UAP Reporting Data Confidentiality and Security Some examples of what is reviewed during an investigator site audit follow.

5. Study Personnel Lists All study personnel must be submitted to the IRB before working on the study This includes all investigators and other study personnel The purpose is to check COI and training records The OHR-1 and OHR-12B and C are used to submit/remove study personnel No study activities can be performed unless an individual has been approved by the IRB OHR Website > IRB Reference Documents > Guidance for Staffing of Personnel on Research Studies

6. Documentation of IRB Submissions Is documentation of each IRB submission available? e.g. Approval Letters, OHR Forms, Stamped Consents

7. Consent Is there valid consent for each patient? Was the correct consent form used? Are all signatures and dates on the consent? Was the correct process followed for: Assent, Surrogate Consent, Short Form Consent, etc.

8. Serious Adverse Events (SAE) and Unanticipated Problems (UAP) SAEs and UAPs must be reported in AE logs, to the sponsor, to the IRB (in eSAEy and eazUP).

9. Serious Adverse Events (SAE) and Unanticipated Problems (UAP) SAEs and UAPs must be reported in the required time frames. These are the time frames for reporting to the IRB: The clock starts when PI/study team become aware of the event and stops when the report is electronically signed by the investigator.

10. Data Confidentiality and Security Keep subject data confidential and secure. Only record and share data as described in protocol. There is a list of 18 items that make data identifiable. If any of the identifiers are present, the data is considered identifiable. Identifiable data should be in a locked cabinet in a locked room.

11. The list of 18 items that make data identifiable. 1.Names 2.Addresses (smaller than a state) 3.Dates (year and age sometimes ok, DOB not OK) 4.Phone Numbers 5.Fax Numbers 6.Email Addresses 7.Social Security Numbers 8.Medical Record Numbers 9.Health Plan Beneficiary Numbers

12. The list of 18 items that make data identifiable. 10.Account Numbers 11.Certificate/License Numbers 12.Vehicle Identifiers/Serial Numbers/License Plate 13.Device Identifiers/Serial Numbers 14.Universal Resource Locators (URLs) (Resource) 15.Internet Protocol (IP) Addresses (Device) 16.Biometric Identifiers (Fingerprints/Voice) 17.Full Face Images, Other Identifiable Images 18.Any Unique Identifying Number, Characteristic or Code This list is a summary. Please see 45 CFR 164.514 for the full list.

13. Data Confidentiality and Security Any of the information in red makes the data identifiable. RS, Age 51, Born 1965, PA RS, Age 51, Born Jan 1965, PA RS, Age 51, Born 1965, Philadelphia, PA 19010 RS, Age 51, Born 1965, PA, MR# 1231234 RS, Age 90, PA RS, Born 1925 Any indication that the patient is over 89 years of age could make the data identifiable.

14. This may not be considered identifiable.

15. This is identifiable.

16. Protocols often indicate that data or samples will be identified only with a code. Including more information, like the example below, does not protect the patient’s identity. Sub: 001 Pat Herbison Herpes Simplex 10

17. Quality Improvement Program The activities of the Quality Improvement Program continue on the following slides. Investigator Site Audits Essential Documentation Binders Compliance Help Policies and Forms Website and Announcements Consent Observations

18. Essential Documentation Binders The binders have a section for each type of study document that must be maintained. Hardcopies are available and the materials are on the OHR website.

19. Compliance Help Please call or email with any compliance or study documentation questions.

20. Policies and Forms We maintain the OHR Policies and Forms. Please send any suggestions for improvement.

21. Consent Observations You will be observed consenting a patient. You will get helpful feedback to help you improve your consent process.

22. QUESTIONS ABOUT: Investigator Site Audits Consent Observations Essential Documentation Binders Compliance Help Policies and Forms Website and Announcements QUESTIONS ABOUT: Making a Submission Forms Needed for a Submission IRB Processes The Status of Your Submission Patrick HerbisonKyle Conner and OHR Personnel Please address questions to:

23. Website and Announcements Link to OHR Home Page: http://www.jefferson.edu/university/human_research.html The Following are some of the resources on the OHR Website: IRB Forms About IRB Submissions JeffTrial and Portal Essential Study Documentation eSAEy and eazUP Policy and Procedures Manual IRB Reference Documents CITI – Training List Contacts

24. Questions ? If you have any questions or need anything, please contact: Patrick Herbison Heather Krupinski