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OHR Quality Improvement Program - Ensuring Compliance and Data Integrity

The Office of Human Research (OHR) Quality Improvement Program led by Patrick Herbison and Heather Krupinski focuses on investigator site audits, consent observations, maintaining essential documentation binders, compliance assistance, policies and forms enforcement, and effective communication through website and announcements. The program covers IRB submissions, data confidentiality and security protocols, and guidelines on identifying and securing data. For more information and resources, visit http://www.jefferson.edu/university/human_research.html. Contact us for any inquiries.

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OHR Quality Improvement Program - Ensuring Compliance and Data Integrity

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  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 • 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

  9. 18 Identifiers • Account Numbers • Certificate/License Numbers • Vehicle Identifiers/Serial Numbers/License Plate • Device Identifiers/Serial Numbers • Universal Resource Locators (URLs) (Resource) • Internet Protocol (IP) Addresses (Device) • Biometric Identifiers (Fingerprints/Voice) • Full Face Images, Other Identifiable Images • 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

  12. Example

  13. Example

  14. Example • 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_research.html • How to Submit to the IRB • JeffTrialand Portal • IRB Forms • CITI – Training List • Policy and Procedures Manual • eSAEy and eazUP • Contacts • Rosters • Newsletters • Announcements • IRB Schedule

  20. Questions?

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