Overview:

Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct.

As the Principal Investigator is responsible for the conduct of the study according to the protocol she/he signed, it is imperative that they ensure that all staff know the protocol and follow it to the letter. If and when a deviation or violation of the protocol is found, meaning that the protocol was not followed (PNF) it must be reported, reviewed and acted upon for Corrective and Preventative Action (CAPA). Also, the differences between and differing significances of "Deviations" and "Violations" must be clearly understood by all persons involved in the conduct of clinical research studies.

One of the problems in this area is that the regulations do not have clear definitions of what a protocol deviation or violation is but one must know that the FDA Compliance Guidelines makes up for this. This Webinar makes the case that all incidents of PNF should be discouraged and avoided by all sites and CROs as their standard.

It is important to see what the FDA regulations and the ICH GCP recommendations are in regard to PNF. Most importantly, when does 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
  

• Principal Investigators and sub investigators
• Clinical Research Scientists (PKs, Biostatisticians)
• Research managers
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting staff
• QA / QC auditors and staff
• Study Monitors
• Clinical Research Data managers.