Do You Have Appropriate Oversight? Understanding the Role of DSMBs
Clinical trials are complex. Independent data monitoring committees or data safety monitoring boards (DMCs or DSMBs) provide necessary support to sponsors and CROs in the conduct of clinical trials. Often required by regulators, these committees are increasingly best practice to oversee the trial data and provide unbiased opinions to keep participants safe and your research moving forward.
In this webinar James Riddle, Advarra Vice President of Research Services & Strategic Consulting, and Barbara Schneider, Advarra Executive Director of Biostatistical Services, take a look at the role and function of independent DMCs from charter creation through interim data analysis. They also outline the US FDA and EU EMA guidelines governing when DMCs are required as part of the overall trial’s data and safety monitoring plan, and prepare you to be ready to work collaboratively with an independent DMC on your next trial.
- Define the basic FDA and EMA guideline requirements governing when DMCs should be employed in clinical trials
- Outline key takeaways to prepare your research program for engaging collaboratively with an independent DMC
- Explain the role of the DMC and how their oversight is different than institutional review board (IRB)
- Summarize the difference, or lack thereof, between DMC and DSMB
MCSE, CIP, CPIA, CRQM
Vice President, Research Services & Strategic Consulting
Executive Director, Biostatistical Services
Who should watch?
This content applies to research professionals representing sponsors, CROs, and institutions who are involved in the planning, development, and execution of clinical drug and device trials.
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
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DATE: September 9, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour