IRB Administration

This course offers a comprehensive review of the critical areas associated with IRB and IRB office operations.

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About this Course


IRB Administration provides members of an Institutional Review Board’s (IRB) administrative office and Human Research Protection Program (HRPP) with a comprehensive review of the critical areas associated with IRB and IRB office operations. This is a role-specific course designed for IRB administrators, directors, coordinators, and other staff.

This course was written and peer-reviewed by experts.

Language Availability: English

Suggested Audiences: Coordinators, Directors, IRB and HRPP Administrators, Other Staff

Organizational Subscription Price: $500 per year/per site
Independent Learner Price: $165 per person

Demo Instructions

Course Content


HRPP/IRB Policies and Procedures CME/CEU Badge

Provides learners with an understanding of both the requirements and best practices for IRB written procedures, procedure development and content, techniques for effective procedure implementation, and elements of effective procedure management.

Recommended Use: Required
ID (Language): 16503 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra; Jaime A. Arango, EdD, CIP - CITI Program

Reporting to Federal Agencies CME/CEU Badge

Discusses when and how a HRPP should communicate reportable events to federal agencies, in a concise and efficient manner. It covers when a report must be filed with a federal agency and what to include in the report. It also contains basic information including contact information for federal agencies.

Recommended Use: Required
ID (Language): 16593 (English)
Author(s): Helene Lake Bullock, PhD, JD - University of Kentucky

Communicating with Subjects CME/CEU Badge

Provides guidance to IRB administrators on circumstances and procedures that should be considered when communicating with subjects before, during, or after their participation in a research study. It describes the circumstances, under which communication with subjects is required, identifies best practices regarding how to communicate with subjects from the IRB and IRB administrator’s perspective, and explains how subject complaints should be handled by the IRB and IRB administrator.

Recommended Use: Required
ID (Language): 16668 (English)
Author(s): Judy Matuk, MS - HRP Consulting Group, Inc.; Cheryl A. Savini - HRP Consulting Group, Inc.

Internal Quality Assurance and Quality Improvement of the HRPP CME/CEU Badge

Provides a general overview of how a HRPP quality assurance/quality improvement (QA/QI) audit program may be structured and why, and focuses on two common types of QA/QI audits: audits of the conduct of individual research studies and audits of the IRB review and approval process. It defines the types of internal QA/QI audits by intent and the responsible and participating entities, describes factors that shape the structure of different QA/QI programs, and discusses how findings and information may be used by a HRPP and IRB.

Recommended Use: Required
ID (Language): 16678 (English)
Author(s): Susan Corl, MSW, MPH, CIP, CCRP - Boston Children's Hospital; Eunice Yim Newbert, MPH - Boston Children's Hospital

External Oversight of the HRPP/IRB: Monitoring and Inspections CME/CEU Badge

Focuses on monitoring and inspections of HRPPs/IRBs. Monitoring and inspections are both types of external oversight provided by study sponsors and regulatory agencies. It defines and identifies the differences between monitoring and inspections, and discusses how each applies to a researcher, specific trial, and IRB.

Recommended Use: Required
ID (Language): 16679 (English)
Author(s): Eunice Yim Newbert, MPH - Boston Children's Hospital; Susan Corl, MSW, MPH, CIP, CCRP - Boston Children's Hospital


Additional Modules of Interest


Single Institutional Review Board (sIRB) Use and Administration: When Relying on a sIRB

Explores key considerations when implementing sIRB relationships and what a participating site needs to do in preparation for relying on an external sIRB.

Recommended Use: Supplemental
ID (Language): 17387 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra; Raffaella Hart, MSHS, CIP - BRANY IRB

Single Institutional Review Board (sIRB) Use and Administration: When Serving as a sIRB of Record

Discusses key elements and considerations for setting up an IRB to serve as a sIRB.

Recommended Use: Supplemental
ID (Language): 17388 (English)
Author(s): James Riddle, MCSE, CIP, CPIA - Advarra; Raffaella Hart, MSHS, CIP - BRANY IRB

Single Institutional Review Board (sIRB) Use and Administration: Authorization Agreements

Introduces best practices for drafting, reviewing, and implementing authorization agreements between the sIRB and participating sites in multi-site research.

Recommended Use: Supplemental
ID (Language): 17392 (English)
Author(s): Cindy Gates, JD, RN, CIP - University of Miami


CE Credits and Units


To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first. Learn more about CE/CME Credits.

Physicians
AMA PRA Category 1 Credit
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2023
Psychologists
CEP Credit/Hour
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2023
Pharmacists
CPE Contact Hour
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2023
Nurses
Nursing Contact Hour
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2023
Social Workers
Ethics CE Credit
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2023
Other Participants
Certificate of Participation
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2023

FAQs


How long does this course take to complete?

This course consists of five modules that contain detailed content, images, supplemental materials (such as, case studies), and a quiz. Learners may complete the modules at their own pace. Each module varies in length, and learners may require different amounts of time to complete the module based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means this course may take learners around three hours to complete.

Who should take this course?

IRB Administration is intended for IRB administrators, directors, coordinators, and other support staff.

How often should I take this course?

There is no one uniform standard regarding how frequently IRB Administration training should occur. However, most organizations select a three-year period of retraining.

What are the standard recommendations for learner groups?

CITI Program allows organizations to customize their learner groups, which means they can choose the content modules their learners need to complete. We will work with your CITI Program designated admin to determine the learner groups that best fit your organizational needs.

The typical recommendation for this course is to designate the following modules as Required:

  • HRPP/IRB Policies and Procedures
  • Reporting to Federal Agencies
  • Communicating with Subjects
  • Internal Quality Assurance and Quality Improvement of the HRPP
  • External Oversight of the HRPP/IRB: Monitoring and Inspections

Is the IRB Administration course eligible for continuing medical education credits?

Yes. Please see the information above for details. For more information on how to ensure CME credit availability for learners at your organization, contact support@citiprogram.org or 888.529.5929.

What are the advantages CITI Program’s IRB Administration training?

IRB Administration provides role-specific, peer-reviewed training written by IRB administration experts. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for IRB Administration training.


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