Presentation is loading. Please wait.

Presentation is loading. Please wait.

February 12, 2014 Non-CISO Non-CTU Studies: How They Differ.

Published byMarilyn Hopkins Modified over 8 years ago

Similar presentations

Presentation on theme: "February 12, 2014 Non-CISO Non-CTU Studies: How They Differ."— Presentation transcript:

1 February 12, 2014 Non-CISO Non-CTU Studies: How They Differ

2 Participating in a Study Various ways Sponsor approaches physician Physician approaches Sponsor Principal Investigator will approach a colleague

3 Departmental Approval Various ways to review scientific merit, logistical (adequate coordinators, competitive trials, etc.) and financial feasibility Departmental committee Administrator Reviewer

4 CONTRACTS/BUDGETS IRB SUBMISSION PROCESS OTHER COMMITTEES (eg. Noridian Medicare Analysis, Value Analysis Committee, Conflict of Interest Committee)

5 Contracts Submission Various Sources Industry Sponsored (eg. Novartis): Submit Clinical Trials Office (CTO) via TRUE 2.0 Federally Sponsored (eg. NIH): Submit to Contracts and Grants Office via email Foundation (eg. AHA): Submit to Contracts and Grants Office via email to Henryk Chrostek Departmental (eg. Investigator-initiated)

6 IRB Submission  Coordinator, research RN, or PI will submit IRB application through istar. Applications will include protocol, informed consent from on USC template, measures, recruitment materials, etc.  Applications fall under 3 classes:  Exempt: less than minimal risk (no known physical, psychological, emotional, or financial risk) such as anonymous or publically available data collection (only IRB can make determination of Exempt status not PI). Reviewed by Chair or designee.  Expedited: minimal risk found comparable to daily life such as extra tube of blood drawn from a patient already undergoing a standard blood draw. Reviewed by Chair or designee.  Full Board Review: greater than minimal risk such as research testing an experimental drug to see if safe or effective.

7 New Staff and Faculty: New Employees need 3 certificates (HS, GCP, and HIPAA) in order to conduct research and gain istar access: For your Human Subject and GCP certification course go to: https://www.citiprogram.org/ https://www.citiprogram.org/ For your HIPAA certification course go to: http://ooc.usc.edu/hipaa-online- education-programhttp://ooc.usc.edu/hipaa-online- education-program https://istar- chla.usc.edu/iStar/Rooms/DisplayPages/LayoutInitial?Container=com.web ridge.entity.Entity%5BOID%5B442D5C79B006C04897775F96FD41AF4 C%5D%5D

Download ppt "February 12, 2014 Non-CISO Non-CTU Studies: How They Differ."

Similar presentations

The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.

The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
IRB Insights UTHSC IRB 448-4824. Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change.

IRB Insights UTHSC IRB Categories Review Process – Exempt – Expedited – Full Board Forms – Initial Application – Form 2 – Change.
What is a Data and Safety Monitoring Plan and how do I get one? Presented by Office of Human Research Protection.

What is a Data and Safety Monitoring Plan and how do I get one? Presented by Office of Human Research Protection.
IRB SUBMISSION PROCESS FOR SHB STUDIES Version 9/18/2013.

IRB SUBMISSION PROCESS FOR SHB STUDIES Version 9/18/2013.
Sharon Harris, Clinical Research Coordinator. SEND PROTOCOLS TO: Clinical Trials Review Committee (CTRC) University Research Administration (URA) Institutional.

Sharon Harris, Clinical Research Coordinator. SEND PROTOCOLS TO: Clinical Trials Review Committee (CTRC) University Research Administration (URA) Institutional.
1 Human Subjects Research at Johns Hopkins Medicine Introduction to Clinical Research - 2010 Human Subject Protection and IRBs.

1 Human Subjects Research at Johns Hopkins Medicine Introduction to Clinical Research Human Subject Protection and IRBs.
IRB 101: Introduction to Human Subject Research

IRB 101: Introduction to Human Subject Research
Research Involving Human Subjects Review of Risk and Protection from Harm.

Research Involving Human Subjects Review of Risk and Protection from Harm.
IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University.

IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University.
Office of Research Integrity Office of Research Integrity Orientation Session November 8, 2012 ECSS 2.102.

Office of Research Integrity Office of Research Integrity Orientation Session November 8, 2012 ECSS
How to Obtain Institutional Review Board (IRB) Approval Richard Wagner Associate Director UCSF Human Research Protection Program August 14, 2008.

How to Obtain Institutional Review Board (IRB) Approval Richard Wagner Associate Director UCSF Human Research Protection Program August 14, 2008.
 About SP ERC  Role of SP ERC  SP ERC Members  ERC Operations  Definition of Research  Definition of Principal Investigator (PI), Co-PI, Collaborator.

 About SP ERC  Role of SP ERC  SP ERC Members  ERC Operations  Definition of Research  Definition of Principal Investigator (PI), Co-PI, Collaborator.
How To Begin Doing Human Subjects Research Teri Bycroft Associate Director of Human Subjects Research.

How To Begin Doing Human Subjects Research Teri Bycroft Associate Director of Human Subjects Research.
Research and Development Protocol Submission and Continuing Review Processes Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas.

Research and Development Protocol Submission and Continuing Review Processes Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas.
Role of the Oncology Research Team Carmen B. Jacobs, RN, OCN, CCRP.

Role of the Oncology Research Team Carmen B. Jacobs, RN, OCN, CCRP.
 Understanding the IRB Process University of Tennessee Health Science Center Institutional Review Board.

 Understanding the IRB Process University of Tennessee Health Science Center Institutional Review Board.
What you need to know about the Saint Leo IRB review process.

What you need to know about the Saint Leo IRB review process.
IRB Survival: Part 1 Karen Blackwell, MS, CIP Director, Human Research Protection Program Fall 2008.

IRB Survival: Part 1 Karen Blackwell, MS, CIP Director, Human Research Protection Program Fall 2008.
Laura M. Argys Associate Dean for Research and Creative Activities College of Liberal Arts and Sciences University of Colorado Denver.

Laura M. Argys Associate Dean for Research and Creative Activities College of Liberal Arts and Sciences University of Colorado Denver.
HIPAA and Research Basics for IRB Tim Atkinson Director, Research and Sponsored Programs Director, Institutional Review Board Research Privacy Officer.

HIPAA and Research Basics for IRB Tim Atkinson Director, Research and Sponsored Programs Director, Institutional Review Board Research Privacy Officer.

Similar presentations

Ads by Google