Needham, MA (PRWEB) October 11, 2008
The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors addresses an emerging reality in clinical research today: As the number of FDA-issued warning letters to clinical investigators has risen in recent years, so too have citations regarding investigators' failure to complete the 1572 appropriately and correctly.
This new, state-of-the-art reference guide was developed to help not only experienced clinical investigators, who continue to struggle with addressing emerging trial-related complexities of modern clinical trials in the 1572, but the growing number of investigators who are conducting their first FDA-regulated trials each year. In addition to the FDA's emerging expectations regarding the 1572, the new reference guide directly addresses new 1572-related challenges facing clinical investigators and industry trial sponsors, including: the implications of what the FDA calls the "dispersing of study functions;" Norway's recent ban against the 1572; the evolution of the "subinvestigator" concept; and the increasing role of non-U.S. clinical investigators in FDA-regulated clinical trials.
The Form FDA 1572 reference guide addresses the most often-asked--but never answered--questions and also explores emerging areas of uncertainty related to the growing complexity of today's clinical trials, including:
- When must a non-US clinical investigator sign a 1572?
- How can a clinical investigator determine when a member of the site staff should be identified as a "subinvestigator"?
- What are the legal/regulatory implications of signing a 1572--is it a legal contract?
- When can a sponsor consider a clinical investigator to meet the "appropriate expert" standard?
- What do we do now that at least one foreign country has banned the use of the 1572 for its clinical investigators?
- How should "co-investigators" be handled in the 1572?
- Must clinical investigators sign 1572s for "satellite sites"?
- What must a study sponsor do beyond "collecting the paper" in the 1572 process?
The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors is available from Barnett Educational Services for $45 per copy (bulk discounts available) by calling 1-800-856-2556 or click here to order your copy today.
About Barnett International
Barnett International is a recognized leader in clinical education and training for all levels of staff involved in the drug development process. In addition, Barnett is the publisher of the GCP Q&A Guide, the PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook, and other well-known reference manuals that help research facilities ensure compliance by providing updates about the latest federal regulations, while offering executives valuable information garnered from real-world studies, analyses, and widely respected industry opinion leaders. For more information on Barnett's publications and educational programs, visit http://www.barnettinternational.com
About Cambridge Healthtech Institute
Cambridge Healthtech Institute (CHI) (http://www.chicorporate.com) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business. CHI's portfolio of products includes Cambridge Healthtech Institute Conferences, Pharmaceutical Strategy Series, Barnett International, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners and Cambridge Healthtech's Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.