80022873: Data and Safety Monitoring Boards: Skills Building Workshop

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ACCREDITATION STATEMENT
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CREDIT DESIGNATION STATEMENT
The Johns Hopkins University School of Medicine designates this educational activity for a maximum of 6.25 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

This link gives directions directly to the Pre-Clinical Teaching Building.
http://www.bs.jhmi.edu/mbg/chenlab/directions.asp

Dear Prospective Participant:

The Data Safety Monitoring Board (DSMB) plays a critical role in augmenting clinical research, by providing specialized and objective oversight of study data that is attentive of human subject safety and data integrity. Moreover, it is the DSMB’s often exclusive access to study data that engenders a unique perspective to gauge study progress, conduct, and outcomes. DSMBs are increasingly seen as indispensible mechanisms to improving clinical research. At The Johns Hopkins University, we are seeking to address this demand, by offering The Data Safety Monitoring Board - Skills Building Workshop. Further, because the course’s faculty represents the highest level of expertise and experience with DSMB formulation and operation, the Workshop is an incomparable resource.

In addition to learning about the fundamentals of DSMBs, it is my hope that you will feel prepared and confident to accept membership into a DSMB or convene your own. So, on behalf of The Johns Hopkins University School of Medicine, Center for Clinical Trials, Berman Institute of Bioethics and The Institute for Clinical Trials and Translational Research at Johns Hopkins, I encourage you to take advantage of this unique course.

Sincerely,

Daniel E. Ford, MD, MPH
Vice Dean for Clinical Investigation

Description:
Clinical trials are subject to many types of oversight, including careful monitoring and evaluation of the study protocol, study progress and safety. Further, federal policies require that many clinical trials have data and safety monitoring plans, which often involve data and safety monitoring boards (DSMBs) or data and safety monitoring committees. However, given the lack of established standards, variable policies and general inexperience with data and safety monitoring, investigators are faced with difficulties in designing, initiating and conducting effective data and safety monitoring plans or serving on DSMBs. Similarly, those assembling DSMBs face substantial challenges in identifying persons with expertise and experience to serve on them.
To address these needs, The Johns Hopkins University Center for Clinical Trials, Berman Institute of Bioethics and The Institute for Clinical Translational Research present a one-day workshop designed to address key concepts in data and safety monitoring of clinical trials. Topics include the ethical and historical bases for data and safety monitoring, the key components of monitoring plans and the structure and functions of DSMBs. This workshop should benefit those designing and sponsoring clinical trials as well as those interested in serving on DSMBs.

Objectives:
After attending this activity, the participant should be able to:
• Recognize the historical foundations and need for data and safety monitoring in the context of research ethics
• Differentiate the roles and responsibilities of the members of the data and safety monitoring board
• Describe the key components of data and safety monitoring plans concerning the analysis on study and safety data and their respective impacts of scientific integrity and human subject safety
• Identify the main considerations in assembling a data and safety monitoring board and designing and implementing a comprehensive charter.

Talks

Policy On Speaker And Provider Disclosure

It is the policy of the Johns Hopkins University School of Medicine that the speaker and provider disclose real or apparent conflicts of interest relating to the topics of this educational activity, and also disclose discussions of unlabeled/unapproved uses of drugs or devices during their presentation(s). Johns Hopkins University School of Medicine OCME has established policies in place that will identify and resolve all conflicts of interest prior to this educational activity. Detailed disclosure will be made in the activity handout materials.