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

2. Quality Improvement Program Investigator Site Audits Consent Observations Essential Documentation Binders Compliance Help Policies and Forms Website and Announcements

3. Investigator Site Audits Demonstrate Oversight Help Study Teams Random/For Cause Our Choice/Your Choice

4. IRB Submissions All IRB Submission documentation Approval Pages, Stamped Consents, OHR Forms

5. Consent Valid Consent for each Patient Signed, Dated and Documented Assent, Surrogate Consent, Short Form

6. SAE and UAP Reporting Serious Adverse Events Unanticipated Problems Must be reported in required timeframes

7. Data Confidentiality and Security Keep subject data confidential and secure Only record and share data as described in protocol Identifiable data should be in a locked cabinet in a locked room There is a list of 18 items that make data identifiable

8. 18 Identifiers 1.Names 2.Addresses (smaller than a state) 3.Dates (except year, age – NOT DOB) 4.Phone Numbers 5.Fax Numbers 6.Email Addresses 7.Social Security Numbers 8.Medical Record Numbers 9.Health Plan Beneficiary Numbers

9. 18 Identifiers 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

10. Examples RS, Age 47, Born 1965, PA RS, Age 47, Born Jan 1965, PA RS, Age 47, Born 1965, Smallville, PA (00020) RS, Age 47, Born 1965, PA, MR# 1231234

11. Example

14. Protocol: Sample will be identified with a code only Sub: 001 Pat Herbison Herpes Simplex 10

15. Consent Observations Reassurance that you are doing the consent process like (or better than) everyone else

16. Essential Documentation Binders

17. Compliance Help

18. Policies and Forms

19. Website and Announcements http://www.jefferson.edu/university/human_r esearch.html http://www.jefferson.edu/university/human_r esearch.html How to Submit to the IRB JeffTrial and Portal IRB Forms CITI – Training List Policy and Procedures Manual eSAEy and eazUP Contacts Rosters Newsletters Announcements IRB Schedule

20. Questions?