Office of Human Research (OHR)
Quality Improvement Program
Patrick Herbison
Heather Krupinski
Quality Improvement Program
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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
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Names
Addresses (smaller than a state)
Dates (except year, age – NOT DOB)
Phone Numbers
Fax Numbers
Email Addresses
Social Security Numbers
Medical Record Numbers
Health Plan Beneficiary Numbers
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
Examples
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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
Pat
Herbison
Herpes
Simplex 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_r
esearch.html
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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?