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Data Monitoring: Meeting the Needs and Requirements of Sponsors and IRBs
Friday, November 9, 2012 from 10:00 AM to 11:00 AM (PST)
This webinar will cover NIH and FDA guidelines for data monitoring in clinical trials and show how you can implement an adequate data safety monitoring plan that reduces risks to those participating in a human subjects trial.
Why Should You Attend:
Both NIH and FDA had guidance that specifying the use of data and safety monitoring plans for clinical trials and those that involve human subjects. Knowledge of those requirements is needed by not only the investigators but by those reviewing the studies too.
This webinar will cover NIH and FDA guidelines for data monitoring in clinical trials and show how you can implement an adequate data safety monitoring plan that reduces risks to those participating in a human subjects trial. The presenter will discuss different types of data monitoring plans and committees and how the IRB interprets data monitoring as opposed to the industry.
Areas Covered in the Webinar:
- How data monitoring came about.
- NIH and FDA guidelines.
- Elements of a data monitoring committee and of a plan.
- Different types of data monitoring plans and committees.
- Industry vs. IRB interpretation of data monitoring.
- Problems encountered by data monitoring committees.
- Data monitoring report vs. SAE report.
- Progress report examples.
Who will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Human Subjects Research
- Healthcare interested in exploring the field of Clinical Research
- New Clinical Research Coordinator positions (1-2 years)
- New Principal Investigator positions
- Administration in charge of Clinical Research
- Regulatory Compliance
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.