Author: Kelly Bilodeau
Date: 04-07-04 09:09
You've heard their stories. Major academic research centers blasted for clinical research violations. DON'T BE NEXT. FDA and OHRP regulations are aimed at protecting human subjects, but they don't tell you how to comply. We will.
Introducing Clinical Trials Compliance
This 12-page monthly newsletter will provide you with how-to strategies that are missing from today's complex government regulations. We've got your back, whether it's HIPAA, Medicare billing, FDA, or OHRP regulations. Our goal is to keep you in compliance-and in business. Click here for more information or to subscribe: http://www.hcmarketplace.com/Prod.cfm?id=1303&s=EN27222A
Learn from mistakes other sites made
Our team of reporters talk with researchers from sites that have been shut down to find out what went wrong. You'll learn from their mistakes and hear how they are correcting their problems. Clinical Trials Compliance also helps you figure out if your research site is at risk for the same issues.
Is your research site at risk? Take our quiz:
___My research site understands how consent documents will need to be changed under HIPAA.
___I am 100% confident that my facility is billing Medicare for clinical trials appropriately, and has been for the past 10 years.
___My research site uses lawsuit-proof informed consent documents. We are not at risk for a lawsuit.
If you couldn't reply affirmatively to all three statements, relax. Your lifeline is here.
How Clinical Trials Compliance can help:
Consent, eligibility, and adverse-event reporting are the most common compliance oversight problems. The financial losses and legal and public relations fallout are immense. We'll help you minimize risk with:
CASE STUDIES on research sites. Our well-networked reporters find the behind-the-scenes story on why a research site was shut down. Then through analysis, we'll help you figure out if your site could face the same problem.
LAWSUIT ALERTS: Learn who's getting sued and for what. We monitor the outcomes for you, and point out what attorneys were able to capitalize on. You get practical advice from experts aimed at helping you avoid a similar problem.
HIPAA POINTERS: Count on us for plain English explanations on how HIPAA will affect your day-to-day activities, from patient authorization to recruitment to contract language. No one knows HIPAA better than Clinical Trials Compliance.
The latest NEWS from the FDA, OHRP, others. Whatever the government agency, if it affects research, we'll keep you informed. You will receive the latest regulatory news whether it's from the OHRP or FDA, the Office of Inspector General, or a Senate hearing. You'll feel prepared with Clinical Trials Compliance.
Advice from industry experts...
Clinical Trials Compliance gives you access to the most knowledgeable, well-respected group of experts in the nation. Our editorial advisory board members have pledged to pass on their advice and insight from decades of work in clinical trials. Learn from:
James Sheehan Esq., Philadelphia attorney who has personally handled or supervised more than 500 health care fraud cases since 1987. Clinical trials compliance is a main focus, and he has spoken extensively on the issue in recent years. A Harvard Law School graduate, Sheehan also teaches health care fraud at the Rutgers and Widener Schools of Law.
Adil Shamoo, PhD, is a research scientist and widely recognized expert in the area of ethics in clinical research. He has chaired eight international conferences on ethics and research protections and has testified on this issue before Congressional Committees and the National Bioethics Advisory Commission. He was appointed to the National Human Research Protections Advisory Committee in 2000. Shamoo is also the founder and Editor-in-Chief of the journal, Accountability in Research. He is a professor and former chairman of the Department of Biochemistry and Molecular Biology and a member of the graduate faculty of Applied Professional Ethics at the University of Maryland, Baltimore.
Lawrence H. "Doc" Muhlbaier is a well respected Duke University Medical Center faculty statistician and IRB member, who speaks extensively on HIPAA and its impact on research. He co-authored the "Guidelines for Academics Medical Centers on Security and Privacy," and is the privacy officer for the AHRQ-sponsored Clinical Effectiveness Research Teams.
Cynthia G. Kenney, C.M.S.C., CP, CIM, is a certified IRB manager responsible for the program administration for several IRBs. A leader on IRB turnaround, she is a regular speaker for the National Medical Staff, IRB Associations and most recently at the second annual Medical Research Summit in Washington D.C. President and CEO of IRB Specialists, Inc., she has been a certified medical staff services professional and paralegal for more than 20 years.
Don’t miss another issue! Subscribe today—it’s completely risk free!
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