This webinar will introduce the participants to some of the committees that are involved or are necessary for the conduct of clinical trials. The IRB process will normally decide if the trial should be done at all at that institution. Committees like a Drug Safety Monitoring Committee monitor the progress of the study and will do some analyses to see if, for example, the patients are being put at unnecessary risk.
Why Should You Attend
If you are conducting a clinical trial it is important to make sure that these groups are correctly being involved in the study. Typically the Drug Safety Monitoring Board (DSMB) will be unblended. It is therefore critical that the analyses being done there do not go outside that group unless the study is terminated.
These committees can all influence the outcome of the study. It is important that there involvement be as it is planned in the protocol.
Areas Covered in this Webinar
The session will cover the roles of the various committees such as
The Drug Safety Monitoring Board (DSMB) is often unblended and sees preliminary results to see if there are potential problems or the output may be so good that it is unethical to continue the study without publishing the results.
An Adjudication committee is a group of professionals, not involved in the study that are asked to identify important results such as Endpoints and assure that they really qualify as Endpoint management.
The participants will learn what some of these committees are and how and when to interact with them.
Who Will Benefit
The patient in the trial should benefit because the procedures discussed here are design to increase data quality and integrity.
Those conducting the clinical trial will benefit because they will be performing the operations in a more compliant manner.
Richard Chamberlain is the President, Executive Consultant Services, LLC Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning and Computer Systems Validation. Managed large-scale clinical projects including development and validation of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs. Taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems. Assisted in the development and validation of numerous computerized systems in all GxP environments. Assisted with the development of all varieties of Standard Operating Procedures and other required documentation for compliance to regulations. Familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs. Experience responding to FDA Inspections, 483s, and Warning Letters Use of tools such as Gap Analyses, Risk Management, and Quality Management.View all trainings by this speaker