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: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
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


CME/CEU Credits

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 2024
Psychologists
CEP Credit/Hour
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2024
Pharmacists
CPE Contact Hour
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2024
Dentists
ADA CERP Credit
3 Credits
(5 CE certified modules)
$60
1 May 2022
31 May 2024
Optometrists
COPE CE Credit
3 Credits
(5 CE certified modules)
$60
1 May 2022
31 May 2024
Nurses
Nursing Contact Hour
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024
Dietitians
CDR CPEU
3 Credits
(5 CE certified modules)
$50
1 May 2022
31 May 2024
Social Workers
Ethics CE Credit
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024
Athletic Trainers
Category A hour/CEU
3 Credits
(5 CE certified modules)
$50
1 May 2022
31 May 2024
Other Participants
Certificate of Participation
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024


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