- URL: http://www.lifesciencetraininginstitute.com/doc/implementing-the-new-nih-fda-clinical-trial-protocol-template-training-0001
- Date: 09/20/2016
- Listed: November 2, 2016 9:43 am
- Expires: This ad has expired
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template
Date: RECORDED VERSION
Time: 1:00pm-2:30pm, EDT US
Price: $299 – Includes Bonus Handouts!
The National Institutes of Health (NIH) and the U.S. Food & Drug Administration (FDA) are suggesting a standardized format for protocols utilized in conducting Phase II and III clinical trials under an IND (Investigational New Drug) or IDE (Investigational Device Exemption).
Investigators applying for NIH grants must use this template. However, since FDA is involved, they are suggesting that sponsors and investigators also follow the template and retain the sections in the order provided.
This course will discuss the template and review the various sections to provide course attendees with an understanding of the required format as well as preparing for implementation.
During this interactive, 90-minute session, you will learn:
*Important pieces of the template, and how it differs from conventional protocols
*How to interpret the template requirements, and marry them to your current efforts
*Important pitfalls to avoid and risk mitigation strategies
*Implementation of the template and strategies for continuous improvement
Who Should Attend
This course will be of benefit to anyone who is involved in drafting, reviewing, amending, and submitting clinical protocols for Phase II and/or Phase III clinical studies (e.g. investigators; clinical research staff including Medical Writers, Study Managers etc.; Quality Assurance staff and Regulatory Affairs staff who review protocols).
Information about the ad poster
- Listed by: email@example.com
- Member Since: September 7, 2016
Other items listed by firstname.lastname@example.org
- FDA Guidance on Social Media: Questions Answered and Unanswered
- The Future Of Outsourcing In Clinical Research – Preparing For A Changing Global Landscape
- Update to ICH GCP E6 (R2) – Changes and Implementation
- “Powering Up” Your GMP Training – Make Training Fun!
- Pediatric Clinical Trials: Special Considerations and Requirements (RECORDED WEBINAR)