'Good Clinical Practice: A Question and Answer Reference Guide 2008' Answers Approximately 500 of the Most Common and Difficult Questions.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/research/b7fc26/good_clinical_prac) has announced the addition of the "Good Clinical Practice: A Question and Answer Reference Guide 2008" report to their offering. Good Clinical Practice: A Question and Answer Reference Guide 2008 Expanded and Updated for 2008! For CRAs, investigators/sites, auditors, compliance, legal, and other clinical professionals... "This book should be mandatory reading for every person involved in clinical research." Munish Mehra, Ph.D., Managing Director, Global Drug Development Experts WHAT'S NEW FOR 2008: - 100+ pages of new brand new content, plus hundreds of updated Q&As - 80 new Q&As focused on emerging areas of GCP GCP Good Clinical Practice GCP Ground Control Point GCP Global Carbon Project GCP Gateway Control Protocol GCP Global Consciousness Project GCP Granulocyte Chemotactic Protein GCP Grand Central Parkway (New York) - New section on GCP in Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies. - Revamped section on Patient Confidentiality/HIPAA in Clinical Trials - Focus on emerging concerns regarding who must be listed as "subinvestigators," clinical investigator A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under supervision of clinical trials, off-site patient visits in clinical trials, and increasing resistance of European clinical investigators to sign Form FDA-1572 THE GOOD CLINICAL PRACTICE: A QUESTION & ANSWER REFERENCE GUIDE 2008: Newly updated and expanded for 2008, this industry-leading GCP training and reference guide answers approximately 500 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drugs and biologics. While continuing with a US/FDA focus, this innovative reference pocket guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , Canada, India, Latin America, Russia and China! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards. With the completely updated and expanded 2008 guide, read why clinical investigators may have to list clinical research coordinators and other study staff as sub-investigators, why some European regulators (including the Norwegian Medicines Agency The Norwegian Medicines Agency (Statens legemiddelverk, Legemiddelverket) is the national, regulatory authority for new and existing medicines and the supply chain. The Agency is responsible for supervising the production, trials and marketing of medicines. ) are warning European clinical investigators not to sign the Form FDA-1572, and what citations in FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. compliance letters should tell you about emerging GCP compliance concerns. Key Topics Covered: In one pocket handbook, you'll have authoritative answers Authoritative Answer or aa is a flag in the answer from a query to a DNS server. It can be seen in the dig DNS lookup utility output when a server gives an authoritative answer, because the server is an authority for the domain. to hundreds of common and emerging questions, in 20+ GCP-related areas, right at your fingertips "Fingertips" is a 1963 number-one hit single recorded live by "Little" Stevie Wonder for Motown's Tamla label. Wonder's first hit single, "Fingertips" was the first live, non-studio recording to reach number-one on the Billboard Pop Singles chart in the United States. : - FDA and ICH See Intel Hub Architecture. GCP Standards for Clinical Research - Form FDA 1572-Statement of Investigator - Informed Consent - Patient Recruitment - State Standards and GCP - Source Data/Documentation - Investigator/Site Requirements - Clinical Monitoring Clinical monitoring - Oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials. - Clinical Study Safety Reporting - Clinical Trial Protocols/Protocol Changes/Protocol Violations - Institutional Review Boards - Quality Assurance Activities/Study Auditing/FDA Inspections - Investigational Drug Accountability, Administration, and Labeling - Now includes a new section on GCP in Latin America! - Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source! For more information visit http://www.researchandmarkets.com/research/b7fc26/good_clinical_prac |
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