IRB Administration Foundations

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

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

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.

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 - Apellis Pharmaceuticals; Eunice Yim Newbert, MPH - Boston Children's Hospital

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 - Apellis Pharmaceuticals

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

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

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