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 relationship with their IRB can have a significant impact on whether study milestones are met.
Join our expert panel to learn about common pitfalls in Phase I study designs, pitfalls in IRB submissions, and strategies to help sponsors and sites plan for success. Our speakers draw on their experiences as IRB members and as Phase I research professionals to provide recommendations that sites and sponsors can use throughout the life of a study.
- Identify common pitfalls in IRB review of Phase I healthy research
- Describe strategies for IRB collaboration and communication
- Outline what an IRB looks for when reviewing Phase I research involving healthy participants
BSHS, CIP, CCRC, CRCP
RN, DBA, CCP
Director, Clinical Protocol Office & Sr. Clinical Research Advisor to the Vice Chancellor of Research
MD, CPI, FAAFP
Physician Scientist IRB Member
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.
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.
DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour