This GCP compliance training will discuss the regulatory requirements for handling protocol deviations and violations and the importance of documentation that is required. The presenter will provide specific examples and proven tips for handling instances of protocol violations.
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:
Following exactly the signed and approved (IRB + PI) Protocol to the letter is the goal and mandate of all clinical research. This, in fact, is included on the FDA Form 1572.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.
Areas Covered in the Seminar:
- The Primacy of the study Protocol.
- What are Protocol “Deviation” and other terms/categories.
- The many cause of protocol deviations.
- The Regulatory requirements for handling protocol deviations and violations.
- The importance of documentation of protocol deviations as well as violations.
- How to define and handle instances of PNF.
- What is the reason different IRBs define deviations and violations differently.
- What is the basis of the difference between a “Deviation” and a “Violation”.
Who Will Benefit:
This Webinar will provide invaluable assistance to the pharmaceutical industry and to investigators and their staff in the regulatory/legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:- 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
Course Provider
Charles H Pierce,
