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ComplianceOnline, Online Event
2012-11-09
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
- Clinical Research Scientists (PKs, Biostatisticians,)
- Clinical Research Data managers
- Safety Nurses
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Organized by:
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Complianceonline |
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Invited Speakers:
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Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students.
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Deadline for Abstracts:
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2012-11-08
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Registration:
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For Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702562?channel=hummolgen
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E-mail:
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referral@complianceonline.com
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