How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant? - We
Venue: Online Training Webinar
|Event Date/Time: Jan 18, 2011||End Date/Time: Jan 18, 2011|
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