How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

Duration: 75-90 Minutes
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”.

CAPA system
Product ID: 500218
If and when a deviation or violation of the protocol is found, 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. Also, learn when does a protocol deviation / change leads to a protocol amendment.. 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.

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.

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.

Objectives of the Presentation:
  • 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
Who can Benefit:
  • 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.
$300
Recorded Session for one participant
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Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Charles H Pierce is President of the virtual CRO Global Clinical Partners, Inc and Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification’s to 2016). He is actively involved in Webinars, courses and workshops.

Charles’ active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU’s). Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU). He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).
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