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:
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!
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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