Clinical Trial Monitoring - Documentation and Closure

Duration: 90 Minutes
Using Good Clinical Practice guidance and the federal regulations, this session will discuss documentation during a clinical trial. Documentation during a clinical trial includes case report forms, source documents and standard operating procedures. This session will also discuss considerations and procedures relevant to closing a study. Once a study is closed, some materials may not be accessible. What may/may not be accessed after study closure will be discussed.
Clinical Trial Monitoring
Instructor: Sarah Fowler Dixon
Product ID: 501769
Objectives of the Presentation
  • Describe the relevant regulations and guidance
  • Provide practical information on case report forms and source documents
  • Discuss use of essential documents
  • Review considerations prior to closing a study
  • Provide information for study close-out visits, audits, and procedures
  • Explore ramifications of closing a study too soon
  • Review common errors
Why Should you Attend
Conducting a clinical trial can be overwhelming. Collecting good data is essential but not possible with the proper tools. This webinar will discuss good documentation practices along with pitfalls to avoid. Included will be practical applications along with advice on how to avoid common errors such as closing a study too early. The practical advice provided in this webinar will help those attending conduct a cleaner trial, leading to fewer headaches. Additionally, the webinar will provide the attendees with information on where to go when more information or advice is needed so to help dissipate the feeling of having to go it alone.

Areas Covered
  • Essential documents: What are they? Where can I get examples? Who is responsible for maintaining and generating these?
  • Case Report Forms vs Source Documents: Can these be kept electronically?
  • Considerations when deciding to close a study
  • Sample materials such as a study closure checklist
  • Close out visit and Internal audits practices
  • Common audit findings and how to avoid these
  • ICH GCP E6
Who will Benefit
  • Human Subjects Research
  • Healthcare interested in exploring the field of Clinical Research
  • Clinical Research Coordinator positions
  • Administration in charge of Clinical Research, Clinical Research Sites
  • Contract Research Organizations , Clinical Research Associates, Regulatory Coordinators
  • Principal Investigator positions, Sub-Investigators
  • Monitors and auditors
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
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