The Institutional Review Board (IRB) is a group that represents the institution and determines what research will be allowed. The Drug Safety Monitoring Board (DSMB) is a group that monitors the study results as the study progresses and can terminate the study early if they detect serious problems, or in some cases can terminate the study early, if the results are so positive that it would be unethical to continue and not release the results. The other groups participate in the generation of results that need to be accurate and timely. Each of the groups discussed play a critical role in the conduct of a clinical trial.
In addition to managing patients visiting your site, there are groups outside your site and perhaps outside yu control that need to be interfaced to what is going on. Perhaps the most obvious one is a Central Lab that has to be processing samples correctly, but there can also be a Pharmacy that might be distributing a Blinded Drug for you study.
Then there can be your organizations IRB setting expectations for you, as well as a Drug Safety Monitoring Bead or Endpoint Adjudication Committee that are reviewing results during the study.
Some of these groups can monitor study results and make a change to the study, in the middle. The other groups participate in the generation of results that need to be accurate and timely. Each of the groups discussed play a critical role in the conduct of a clinical trial.
It is important that you, especially if you are the sponsor of the study, are aware of each of these groups and understand their influences on the study. Any of these committees or labs is subject to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations. Therefore, they must be audited periodically as there can be a tendency to not monitor the procedures and products of these groups.
In this session, expert speaker Richard Chamberlain, Ph.D., will discuss the aforementioned groups and the critical role they play in clinical trials. You will get tips on managing these groups in an effective manner to ensure a successful clinical trial.
Who should attend
At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.
Richard Chamberlain is the President of Executive Consultant Services, LLC, a company that provides consultation to numerous pharmaceutical, contract research organizations, and medical device companies in the areas of computerized project scheduling, strategic planning and computer systems validation. He has broad management experience in a variety of management and technical areas including strategic planning, operational planning, pharmaceutical R&D project management, computer systems development and implementation, and computer systems validation.
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