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GlobalCompliancePanel, Online Training
2011-01-18
Overview: This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of the investigator is handled.
It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. Most importantly, when do a protocol deviation / change lead to a protocol amendment. There are differences in actions, reporting and consequences of deviations and violations and these will be discussed. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. TO not follow the protocol is folly.
Why Should You Attend: Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. Forewarned is forearmed.
Areas Covered in the Session: - How to know when the protocol is not followed (PNF)?
- What is the difference between a protocol deviation and a violation?
- Importance of the "Protocol" in the number of deviations occurring
- How to ensure that the protocol will be followed exactly?
- What is in the Regs about following the protocol?
- When may the Investigator make changes in the protocol?
- What are the causes of Protocol Deviations and Violations?
- How are Protocol Deviations managed?
- Examples of Protocol Violations and Deviations
Who Will Benefit: - Principal Investigators / Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians,)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff.
- Clinical Research Data managers
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.
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Deadline for Abstracts:
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2011-01-18
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Registration:
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Tuesday, January 18, 2011
10:00 AM PST | 01:00 PM EST | | | Live live online training only for one participant | | |
| | | | | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
| | | Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) | | |
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E-mail:
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webinars@globalcompliancepanel.com
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