On-Demand Webinar

IRB Review of Phase I Healthy Research: Investigator and IRB Perspectives

Timelines are particularly critical in Phase I research involving healthy participants. A site’s institutional review board (IRB) relationship can significantly impact study milestones.

Join our expert panel of IRB members and Phase I research professionals to hear about common pitfalls in Phase I study designs, challenges with IRB submissions, and strategies to help sponsors and sites plan for success.

Learning Objectives:

Identify common pitfalls in IRB review of Phase I healthy research
Describe strategies for IRB collaboration and communication
Outline IRB criteria when reviewing Phase I research involving healthy participants

Moderated By

Robert Romanchuk

BSHS, CIP, CCRC, CRCP

Former IRB Chairperson
Advarra

Presented By

Theresa Cummings

RN, DBA, CCP

Director, Clinical Protocol Office & Sr. Clinical Research Advisor to the Vice Chancellor of Research
UNC Lineberger

Randall Stoltz

MD, CPI, FAAFP

Former Physician Scientist IRB Member
Advarra

Pankaj Desai

PhD

Professor and Director, Drug Development Graduate Program, College of Pharmacy
University of Cincinnati

Who should watch?

This content applies to research professionals involved in the planning, IRB review, and conduct of Phase I research involving healthy participants, including representatives from sponsors, CROs, and sites.

CE Credits

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.

This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 1 credit.

Provider approved by the California Board of Registered Nursing, Provider Number 17600, for 1 contact hour. This documentation must be retained by the licensee for a period of 4 years after the course concludes.

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.