Importance of Protocol Deviations and Clinical Research

Duration 90 Mins
Level Basic & Advanced
Webinar ID IQW18K1106

  • 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
  • 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

Overview of the webinar

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by a certified physician investigator, will go over the regulations in a user friendly way. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”.

Who should attend?

  • 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.

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.

Faculty - Mr. Charles H Pierce, MD, PhD, FCP, CPI

Enjoys making presentations and Webinars on a variety of GCP subjects such as Investigator Responsibility in Clinical Research, The Role of Adverse Event Determination and Reporting in Drug Safety, Data and Safety Monitoring Board set-up and use, Importance of Conflict of Interest Avoidance, What is "GCP", How to Document to have a good FDA Inspection, How to prepare for an FDA BIMO Inspection, The Importance of effective Pharmacovigilance.

Specialties

  • Developing Phase I, IIa Clinical Pharmacology Units (CPU) -
  • The safety of the results of Clinical Research - Phase IV (Pharmacovigilance)is essential
  • Clinical Research study conduct from the Regs to practice - including post-market safety
  • Giving Lectures and Webinars on the GCP of Clinical Research - Value of Lab and EKG results on subject safety - How to avoid Protocol Deviations - Importance of good Post-market Pharmacovigilance

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