Managing Clinical Investigators in 2010 and Beyond FDA’s Final Guidance for Investigator Responsibilities

Held Dec. 17, 2009

The new, tougher FDA has issued a final guidance on managing clinical investigators that you ignore at your peril. Here’s how to make sense of these complex new rules.

Your company has invested millions in clinical trials. Now, a newly vigilant FDA has issued a final guidance that could put your hard-earned trial data at risk.

The ink is scarcely dry on a final guidance that requires you to tighten the monitoring of clinical trial investigators and subinvestigators — or pay the consequences.

The guidance includes an all-new section on Site Management Organizations (SMOs). Even people who’ve read it closely admit they may not grasp its full implications.

Wouldn’t it be great to spend 90 minutes with someone who does ... and who can interpret this tough new rule into plain English?

Industry pro Liz Wool is that person. She has read and analyzed the rule forward and backward — even marked it up and highlighted key sections. Now she’s sharing her hard-won knowledge with you.

FREE BONUS: You’ll also get a PDF copy of Ms. Wool’s own marked-up version of the final guidance, highlighting the key sections. You’ll want to share this crucial document with every person on your staff who shoulders clinical trial responsibilities.

Listen to a 90-minute audio CD/Transcript with Ms. Wool as she covers these topics and more:

  1. Core principles and ethical requirements embodied in the final guidance
  2. What to update first — which SOPs and procedural documents take priority
  3. Top 10 basic requirements for the investigator’s protocol — specific clinical trial plans, including management of satellite sites, and as an employee of an SMOs
  4. 8 investigator/site characteristics the FDA uses to determine when an investigator is “overburdened” and should not be doing a study
  5. Top 5 tasks the FDA says the investigator should not delegate to others
  6. Determining which delegated tasks require “medically qualified” staff
  7. A matrix approach to defining “medically qualified” per FDA expectations
  8. 5 required training sessions that investigators must provide
  9. How to know what study supervision meets FDA standards of “adequate”
  10. Ensuring your CRO is in compliance when outsourcing studies

You’ll review case studies of past violations and how the new final guidance has been modified to compel compliance.

This webinar is totally interactive. You’ll get an opportunity to email your questions and receive answers by the time the session ends.

It’s the most economical way to educate dozens, even hundreds, of staffers and colleagues. Feel free to sign up as many registrants as you need to. There’s no limit as long as they’re at the same location.

Don’t delay — order NOW!

  • Study Managers
  • Clinical Quality Assurance Directors
  • Regulatory Affairs
  • CRAs
  • Outsourcing/Contracts Staff
  • Medical Affairs/Monitoring
  • Project Physicians

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Liz Wool, RN, BSN, CCRA, CMT, is president and CEO of QD-Quality and Training Solutions Inc., a consulting firm offering SOPs, standards and training services to investigational site staff, sponsors and CROs. She has been active for 18 years in clinical research positions in sponsor companies, investigational sites, CROs and academia. She is president of the ACRP Northern California Chapter and teaches the CRA Certification Exam Review Course.

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