Quality Data...Delivered by Design™

Quality Data...Delivered by Design™

Webinar: Clinical Trial Documentation

Course Title

Clinical Trial Documentation: Get It Right The First Time!


This webinar session is scheduled at the customer's convenience. Please call 585-381-1350 x246 to schedule.


Review of essential trial documents and their specifications and suggested systems and procedures for getting the documentation right the first time.

Course Description

FDA has been updating their expectations of Essential Documents through new regulations and guidance documents such as financial disclosure and informed consent documents. This course will address the changes in documentation due to these GCP revisions on a document by document basis.

An up-to-date view on Essential Trial Documentation and the specifications for the accuracy and completeness for each document. Systems, processes, and procedures to get it right the first time will be discussed.

Course Content

  • Definition and description of Essential Documents
  • Specifications for each document
  • Latest FDA guidance and regulations as well as ICH requirements for each documents
  • Processes and procedure for getting it right the first time
  • Discussion and questions

Recommended Attendance

  • Clinical Research Investigators
  • Clinical Research Coordinators
  • Monitors
  • Clinical Research Associates
  • Project Managers
  • GCP Auditors
  • Regulatory personnel

Instructor Bio

Lorraine D. Ellis, MS, MBA.
Ms. Ellis is an experienced trainer with in-depth knowledge as a result of hands-on experience in clinical trials and training thousands of clinical research professionals over decades. Ms. Ellis has over 30 years clinical research experience and is the author of several books, articles and other clinical research materials. She has authored and taught over 50 courses designed for clinical research professionals.

She has presented at major industry meetings such as DIA, ACRP, CRO Partnerships and others. Ellis has also served as faculty for ACRP courses, participated in the development of ACRP certification programs, and is an adjunct professor in the MS in Clinical Research Management program at Rochester Institute of Technology.


$150 per person

To Register

If you are interested in attending/scheduling this webinar, Contact us at 585-381-1350 x246.

For other available webinars or on-site courses

Visit our website's training section or Contact us at 585-381-1350 x246.