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Education & Certification

WEBCTSI Training and Education. CTSI offers educational opportunities to USC faculty, staff, students, and scholars in a variety of formats to accommodate the various research …

Actived: 5 days ago

URL: https://hrpp.usc.edu/education_certification/

Chapter 11: Health Insurance Portability and Accountability Act …

WEB11.1 Protected Healthcare Information (PHI) Protected health information (PHI) is any identifiable health information relating to the individual’s past, present, or …

Category:  Health Go Health

Chapter 6: Types of IRB Submissions

WEBChapter 6: Types of IRB Submissions. Revised on: 10/04/2023. All USC human subjects research projects must undergo review and approval by an IRB prior to …

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Chapter 10: Privacy, Confidentiality and HIPAA

WEBTypes of Identifiable Information. Information through which subjects may be identified include names, student identification numbers, hospital ID numbers, social security …

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Chapter 1: USC Human Research Protection Program

WEBThe Human Research Protection Program oversees the ethical and regulatory affairs related to the protection of research subjects. The Program consists of the Vice …

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Forms and Templates

WEBIt is the responsibility of the investigator or study sponsor to provide translation of an IRB approved Informed Consent Form (ICF). For studies that are greater than minimal risk …

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Chapter 12: Investigator’s Role and Responsibilities

WEBCertification Requirements for USC IRB Submission The USC IRB requires that applicable certifications for Good Clinical Practice (GCP), Human Subjects Research Protections, …

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Human Subjects, GCP and HIPAA Education and Certification

WEBAll study personnel conducting research that requires access to Protected Health Information (PHI) must complete Research HIPAA Certification from CITI. This …

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Internet Research

WEBInternet Research Internet based research is no different than other human subjects research in terms of regulatory oversight and requirements.

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Health Insurance Portability and Accountability Act (HIPAA)

WEBHealth Insurance Portability and Accountability Act (HIPAA) The Health Insurance Portability and Accountability Act (HIPAA), also known as the

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FWA and IRB Registration Numbers

WEBFederalwide Assurances (FWAs) A Federalwide Assurance (FWA) is a binding written agreement between USC and OHRP. It states that the University is guided by the ethical …

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Chapter 9: Informed Consent Requirements

WEBRevised on: 3/21/2024. Investigators are required to obtain informed consent as a legal and ethical obligation. This chapter discusses the process of consent, the elements of …

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Expedited Level of Review

WEBSummary of Expedited Categories: Clinical studies of drugs and medical devices only when certain conditions are met. Collection of blood samples by finger stick, heel stick, ear …

Category:  Medical Go Health

Chapter 5: USC Institutional Review Boards (IRBs)

WEBChapter 5: USC Institutional Review Boards (IRBs) Revised on: 4/1/2024. This chapter describes the purpose, role, composition and general procedures of the USC …

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Chapter 13: Vulnerable Subject Populations

WEB13.1 Protection of Children Involved as Subjects in Research (45 CFR 46 Subpart D) State and federal regulations use different terms to describe individuals under the age of …

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Chapter 14: Research with Unique Regulatory considerations

WEBNIH-funded studies that generate large-scale human genomic data are subject to the NIH Genomic Data Sharing (GDS) Policy. According to the GDS Policy, investigators who …

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Chapter 16: FDA-Regulated Research

WEBResearch involving FDA-regulated products may also be subject to 45 CFR 46, California regulations, and institutional policies. 16.1 FDA-Regulated Research. The …

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