On-Demand Webinar

Reefer Sanity: IRB Review That Won’t Vaporize Cannabis Protocols

Cannabis and cannabis-derived products are being used with increasing frequency in both recreational and therapeutic settings. With more widespread use of cannabis, how can data from well-designed clinical research trials better characterize its safety and efficacy as a medicine?

For IRBs charged with reviewing these protocols, the complicated legal history of cannabis and ongoing concerns about its safety can present challenges. Furthermore, aspects of study design pertaining uniquely to botanical medicines—dose standardization, for example—can be difficult for IRBs to evaluate. Despite these challenges, IRBs can help improve the quality of cannabis research by requiring sound study design and adequate safety monitoring.

In this webinar, Advarra IRB experts provide guidance for developing and reviewing cannabis studies with the goal of protecting human subjects while allowing this important field of research to progress.

Learning Objectives

Following this free webinar, attendees will be able to:
  • Describe essential elements of study design needed to generate reliable, reproducible, and generalizable data.
  • Identify elements of safety monitoring needed to protect research subjects and cannabis users in general, including assessment of addiction potential.
  • Apply regulatory criteria to determine review pathway (expedited or full convened board) and approvability.

Presented By

Lizbeth Adams_orange.png

Lizbeth Adams

PhD, CIP

Executive Vice Chair, IRB
Advarra

Amanda Higley_orange.png

Amanda Higley

PhD

IRB Chair
Advarra


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Who Should Watch?

Content applies to investigators, IRB members, sponsor/CRO representatives, and other research professionals involved in the development and conduct of clinical trials involving cannabis.

CEU 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 and 1 hour of continuing education credit for the Certified IRB Professional (CIP) certification. 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 completing this webinar in its entirety, you will receive a certificate of attendance. This certificate will include your full name, and it will be emailed to you at the end of 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 take the survey at the end. Visit our Webinar Help page for more information on certificates of attendance.

Duration: 1 hour

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