Office of Human Research (OHR)Quality Improvement Program

Patrick HerbisonHeather Krupinski

Quality Improvement Program

• Investigator Site Audits• Consent Observations• Essential Documentation Binders• Compliance Help• Policies and Forms• Website and Announcements

Investigator Site Audits

• Demonstrate Oversight• Help Study Teams

• Random/For Cause• Our Choice/Your Choice

IRB Submissions

• All IRB Submission documentation• Approval Pages, Stamped Consents, OHR

Forms

Consent

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

SAE and UAP Reporting

• Serious Adverse Events• Unanticipated Problems• Must be reported in required timeframes

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

18 Identifiers

1. Names2. Addresses (smaller than a state)3. Dates (except year, age – NOT DOB)4. Phone Numbers5. Fax Numbers6. Email Addresses7. Social Security Numbers8. Medical Record Numbers9. Health Plan Beneficiary Numbers

18 Identifiers

10. Account Numbers11. Certificate/License Numbers12. Vehicle Identifiers/Serial Numbers/License Plate13. Device Identifiers/Serial Numbers14. Universal Resource Locators (URLs) (Resource)15. Internet Protocol (IP) Addresses (Device)16. Biometric Identifiers (Fingerprints/Voice)17. Full Face Images, Other Identifiable Images18. Any Unique Identifying Number, Characteristic or Code

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

Example

Example

Example

Example

• Protocol: Sample will be identified with a code only

Sub: 001

PatHerbison

HerpesSimplex 10

Consent Observations

• Reassurance that you are doing the consent process like (or better than) everyone else

Essential Documentation Binders

Compliance Help

Policies and Forms

Website and Announcements

• http://www.jefferson.edu/university/human_research.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

Questions?