Protocol Deviations: Documenting, Managing and Reporting

Duration: 60 Minutes
Deviations have often been misunderstood, misclassified and misreported. This webinar will help you to answer questions about deviations such as: What is a deviation? What’s the best way to manage deviations? Can they be avoided? What is their importance? Does deviations impact subject safety or data integrity? How can the research team anticipate, manage, and minimize the impact of protocol deviations?
Protocol Deviations in Clinical Trials
Instructor: Sarah Fowler Dixon
Product ID: 502254
Objectives of the Presentation
  • Define protocol deviations
  • Review the requirements for reporting such events to regulatory authorities
  • Review ICH guidelines and Good Clinical Practice (GCP)
  • Discuss Department of Health and Human Services (DHHS) guidance
  • Delve into Food and Drug Administration guidance
Why Should you Attend
Clinical investigators are required to conduct a clinical trial according to the research protocol. Most research protocols are written for an ideal world but the studies are carried out in the real world. This creates deviations, whether planned or unplanned. It is important to know what current expectations are regarding reporting to regulatory authorities to avoid non-compliance issues which can create delays in the conduct of research.

Areas Covered
  • FDA Determination Letters regarding deviations
  • Definition of a deviation
  • What ICH, DHHS and FDA say about deviations
  • Types of deviations
  • Review of institutional guidance documents
  • Examples
  • References
Who will Benefit
This webinar will provide valuable assistance to all personnel in:
  • Human Subjects Research
  • Healthcare interested in exploring the field of Clinical Research
  • Clinical Research Coordinators, Associates, and Managers
  • Administration in charge of Clinical Research, Clinical Research Sites
  • Contract Research Organizations
  • Regulatory Coordinators
  • Principal Investigator positions, Sub-Investigators
$375
Recorded Session for one participant
Get life time access with download option!
Book This Course
  $500.00 Training CD
Free shipment within 7 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
  $600.00 Flash Drive
Free shipment within 7 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
Do you want to Host
this webinar at your Organization!
Call us at +1-510-857-5896
Email us at webinar@onlinecompliancepanel.com
Minimum 10 attendees
How it works
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:
Sarah Fowler-Dixon, PhD, CIP is an Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
View More