With the increasing frequency of real-time FDA audits, the importance of the nature and frequency of evidence of “Not following the Protocol” has gained increasing importance. Protocol Deviations and Protocol 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.
Why Should You Attend:
Those of us involved in Clinical Research must know that a well-written protocol is required for good clinical practice as part of research protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollmentis a key element in having a deviation free study conduct.Forewarned is forearmed.
Areas Covered in this Webinar:
How to know when the protocol in clinical research is not followed (PNF)?
What is the difference between a clinical research protocol deviation and a violation?
Importance of the clinical Protocol in the number of deviations occurring
How to ensure that the protocol will be followed exactly?
What is in the GCP Regulations 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
Demonstrate the primacy of the Study Protocol
Determine when the Protocol is not followed (PNF) and what to do when this happens
Describe the difference between a protocol deviation and a protocol violation
Explain why a classification of PNF instances might be helpful
Describe how and when to report Deviations / Violations
Who Will Benefit:
Principal Investigators and Sub Investigators
Clinical Research Scientists (PKs, Biostatisticians)
Clinical Research Associates (CRAs) and Coordinators (CRCs)
Recruiting Staff, QA / QC Auditors and Staff
Clinical Research Data Managers
Charles H. Pierce, MD, PhD, FCP, CPI Has 25+ years experience in the Clinical Research field. He now brings the message (via webinars, lectures and seminars) of Risk Management through knowledge 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. He 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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