Navigation Links
Barnett Releases Reference Guide on Form FDA 1572--Statement of Investigator
Date:10/11/2008

Barnett International, a division of Cambridge Healthtech Institute (CHI), has announced the release of The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors. Designed for clinical investigators, clinical site staff, study monitors, regulatory affairs professionals, and others involved in the clinical research process, the text is the first reference guide to address the Form FDA 1572-Statement of Investigator form, a critical regulatory document that well over 20,000 clinical investigators complete and sign each year before participating in FDA-regulated clinical trials.

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 www.barnettinternational.com

About Cambridge Healthtech Institute
Cambridge Healthtech Institute (CHI) (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.

###

Read the full story at http://www.prweb.com/releases/2008/10/prweb1450214.htm


'/>"/>
Source: PRWeb
Copyright©2008 Vocus, Inc.
All rights reserved

Related medicine news :

1. Downtown Emergency Service Center Releases CHASERS, Free Software for Homeless Service Management and Beyond
2. USP releases first certified reference material
3. change:healthcare CEO Releases 'My Healthcare is Killing Me'
4. AHRQ Releases Two New Resources to Help Consumers and Clinicians Prevent Dangerous Blood Clots
5. Sodexo Releases Innovative Prepaid Incentive Card Powered by eCommLink
6. Z Trim Holdings, Inc. Releases Letter to Shareholders
7. Mindray Releases Historical Financial Results Converted into US Dollar Terms
8. Pennsylvania Trauma Systems Foundation Releases Data Supporting Mandatory Use of Motorcycle Helmets
9. URAC Releases Revised Standards For Nine Health Care Management Accreditation Programs
10. ABC Releases Monograph on Scientific Research of POM Wonderful(R) Pomegranate Juice
11. ProSanos Corporation Releases New Software System to Improve Patient Safety via Surveillance and Analysis of Claims and Electronic Health Records
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... ANGELES , June 23, 2016 ... CAPR ), a biotechnology company focused ... therapeutics, today announced that patient enrollment in its ... in Duchenne) has exceeded 50% of its 24-patient ... enrollment in the third quarter of 2016, and ...
(Date:6/23/2016)... -- , , , WHEN: , ... , , , LOCATION: , , , Online, with free ... EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice President ... Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... is witnessing an exceptional era. Several new demand spaces, such as ...
(Date:6/23/2016)... 23, 2016 Revolutionary technology includes ... Oticon , industry leaders in advanced audiology and hearing ... Oticon Opn ™, the world,s first internet connected hearing ... IoT devices.      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ... number of ,world firsts,: , TwinLink™ - ...
Breaking Medicine Technology: