is being presented by Lorry Witte, RN, BA, CCRC, CCRA, Clinical Research Consultant and airs on Wednesday, August 22nd, 2012. For more details or to register, please visit our site at http://www.fxconferences.com/Implementing-the-FDA-Guidance-on-Investigator-Responsibility-P1009.aspx
It's been some time since FDA released its guidance for industry on investigator responsibilities, but it remains important for investigators, study coordinators, and sponsor staff to regularly train on its content to ensure safe, high quality, efficient, and less costly clinical study conduct. With many studies, time is wasted on “cleaning up” study documentation. However, if all research staff members understand FDA’s current thinking on investigator responsibility, it becomes easier to collaborate in the subjects’ best interest and produce better study results.
This audio conference is intended help investigators and sponsors avoid FDA Form 483 findings and Warning Letters, highlighting what constitutes adequate investigator supervision, appropriate task delegation and adequate study training. Our speaker provides insight and guidance to assist investigators in developing or enhancing their plans for supervision and oversight of clinical trials. After attending the presentation, sponsor staff will be able to better identify robust investigator plans and understand sponsor responsibilities described in the guidance.
The presentation also reviews the protection of rights, safety and welfare of study subjects by providing reasonable medical care necessitated by clinical trial participation, reasonable access to medical care, and importance of avoiding protocol violations that present unreasonable risks for subjects.
