Importance of Protocol Deviations and Clinical Research

Product Id IQW18K1106
Level Basic & Advanced
Duration 90 Mins
Schedule Wednesday, January 16, 2019 | 10:00 AM PST | 01:00 PM EST
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  • Description
  • Why should you attend
  • Areas covered
  • Who will benefit
  • Speaker
  • All-Access Pass

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”.

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.

  • 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
  • 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.

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 Phrmacovigilance.


  • 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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