Quality Data...Delivered by Design™

Quality Data...Delivered by Design™



Webinar: Investigator Responsibilities


Course Title

Investigator Responsibilities


Date

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


Summary

Keep your site compliant. This course will teach you how the latest FDA information affects your daily clinical trial activities. You may need to change what you currently do to continue to be compliant.


Course Description

Investigator responsibilities have evolved over the years to more exacting standards and details. FDA recently (October 2009) released a new guidance that modified some of the earlier guidance. This seminar will provide details on such topics as Investigator Supervision, trial planning, and delegation and protecting subjects.


Course Content

  • Investigator Responsibilities for drugs, biologics, and devices
  • What is adequate supervision
  • Monitors
  • Protecting Human Subjects
  • How you can decide if you and your staff are adequately trained
  • How to determine if your site is in compliance

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.


Cost

$99 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.