TITLE

ACRP comments on FDA draft guidance

PUB. DATE
December 2008
SOURCE
Clinical Trials Administrator;Dec2008, Vol. 6 Issue 12, p142
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports on the comments of the Association of Clinical Research Professionals (ACRP) of Alexandria, Virginia on a U.S. Food and Drug Administration (FDA) draft guidance. The draft guidance concerns the FAQ-Statement of Investigator (Form FDA 1572). Among the questions raised by ACRP president and chief executive officer Thomas L. Adams were the minimum qualifications of an investigator and the manner in which an investigator's name should appear on the 1572.
ACCESSION #
35385663

 

Related Articles

  • Poll: IRBs Should Be Regulated by FDA, Not Industry.  // Applied Clinical Trials;Nov2004, Vol. 13 Issue 11, p18 

    The article informs that there currently is no registry for Investigational Review Boards. A majority of voters (69 votes, 72%) felt that such a registry should be regulated by FDA. Only 13% (12 votes) believes that the registry should be regulated by industry, and 16% (15 votes) thought that...

  • New Year, New Hope. Mullin, Leo F. // Countdown;Summer2008, Vol. 29 Issue 2, p4 

    The article discusses the developments of the international organization named Juvenile Diabetes Research Foundation (JDRF). Founded in 1983, JDRF has spurred hundreds of research pursuits related to diabetes in major universities. It states that the organization's funding has grown from $3...

  • Low-Hanging Fruit: A Pilot Project to Standardize Case Report Forms. Peddicord, Douglas // Applied Clinical Trials;Sep2005, Vol. 14 Issue 9, p58 

    Describes a pilot project undertaken by the Association of Clinical Research Organizations to standardize case report forms used in collecting clinical trial data. Details of the group's proposal to the U.S. Food and Drug Administration to draft standardized templates for two central measures of...

  • Non-Expert Expertise: Chronicling the Success of AIDS and Breast Cancer Activists. Melcher, Charlene // Conference Proceedings -- National Communication Association/Ame;1995 Argumentation & Values, p356 

    The article discusses the achievement of the AIDS and breast cancer activist groups in breaking down the separation between the expert and non-expert arenas in the U.S. The AIDS Coalition to Unleash Power and breast cancer advocacy groups have been successful in improving the drug trial process...

  • FDA: THE GUTLESS TIGER. Jacobson, Michael F. // Nutrition Action Health Letter;Jul/Aug2003, Vol. 30 Issue 6, p2 

    Examines the shortcomings of the U.S. Food and Drug Administration (FDA). Factor being blamed for the slowness and inactivity of the FDA.

  • WASHINGTON report. Dickinson, James D // Medical Marketing & Media;Dec2000, Vol. 35 Issue 12, p30 

    Reports on news and developments related to medical policy in the United States as of December 2000. U.S. Food and Drug Administration's warning against the use of prescription and over-the-counter drugs containing phenylpropanolamine; General Pharmaceutical Association's request for the FDA to...

  • Shrunken glands spark sweetener controversy. Coghlan, Andy // New Scientist;11/23/91, Vol. 132 Issue 1796, p13 

    Reports that a consumer group in the United States has expressed doubts about the safety of sucralose, a sweetener which was approved for sale in Canada in September 1991. Center for Science in the Public Interests' (CSPI) call for additional toxological studies to establish whether the...

  • FDA assigns Drug Master File to European cancer group. Steimle, Sabine // JNCI: Journal of the National Cancer Institute;09/16/98, Vol. 90 Issue 18, p1331 

    Reports that the Treatment Division of the European Organization for Research and Treatment of Cancer (EORTC) in Brussels, Belgium received a Drug Master File number from the United States Food and Drug Administration (FDA). Significance of the move by the FDA; What is the assigned Drug Master...

  • FDA Advisory Committees: Their Purpose, How They Work, and How You Can Become a Member. Brady, Charles // American Journal of Gastroenterology;Apr2006, Vol. 101 Issue 4, p689 

    The article provides information about the purpose, operation and membership associated with the advisory committees of the U.S. Food and Drug Administration (FDA). Advisory committees of the FDA offer independent expertise and technical guidance to the development of the safety of the products...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics