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Deviations: What are they? Do you need to report?
Wednesday, December 12, 2012 from 10:00 AM to 11:00 AM (PST)
This webinar will help you clearly understand, classify and determine what deviations to report in clinical studies. It will also explain, in detail, the terminology applied to deviations.
Why Should You Attend:
As the human subjects regulatory framework continues to grow and be further defined, it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) prior to implementation by the study team. Alternatively, as studies become more complex and complicated the study team often has to make immediate decisions which may not allow time for a regulatory consult.
In this session, we will discuss what the current expectations are regarding reporting to regulatory authorities to avoid non-compliance issues which can create delays in the conduct of research. This presentation is designed to define protocol deviations and review the requirements for reporting such events to regulatory authorities.
Those who attend this session should be able to identify a deviation and be able make an initial determination as to whether the deviation may be reportable to the Institutional Review Board (IRB).
Areas Covered in the Seminar:
- ICH guidelines and Good Clinical Practice (GCP).
- Department of Health and Human Services (DHHS) guidance.
- Food and Drug Administration guidance.
- Types of deviations.
- What constitutes a reportable event.
- Review of institutional deviation policies and guidance documents.
- Review of Office for Human Research Protections (OHRP) determination letters regarding deviations.
- Deviation examples.
- Links to useful resources.
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.