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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?