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FDA Guidances on Good Clinical Practice
Guidances, Information Sheets, and Important Notices on Good Clinical Practice in FDA-Regulated Clinical Trials.
FDA 21 CFR Part 11 Compliance References
Compliance References for Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures on the U.S. Food and Drag Administration official site.
Electronic Regulatory Submissions and Review
The Center for FDA's Drug Evaluation and Research's Electronic Regulatory Submissions and Review (ERSR) web page. This page provides information about the electronic submission of regulatory information to the Center and the review of it by CDER staff.
Applied Clinical Trials
A global, peer-reviewed journal about the process of managing clinical trials.
Bio-IT World: Clinical Trials & Research
The leading source of news on technology and strategic innovation in drug discovery, development, and clinical trials.
CDISC Standards
Links of standard models of Clinical Data Interchange Standards Consortium (CDISC).
Health Level Seven (HL7)
Health Level Seven is one of several American National Standards Institute (ANSI) - accredited Standards Developing Organizations (SDOs) operating in the healthcare arena.
The Society for Clinical Trials
SCT is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct and analysis of government and industry-sponsored clinical trials and related health care research methodologies.
The Society of Clinical Research Associates, Inc.
The Society of Clinical Research Associates, Inc. is a non-profit, professional organization dedicated to the continuing education and development of clinical research professionals.
The Tufts Center for the Study of Drug Development
an independent, academic, non-profit research group affiliated with Tufts University dedicated to develop strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization.
History of Clinical Trials: How it All Begin
History of clinical Trials by HealthandAge.com.
ClinicalTrials.gov
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world.
ClinPage.com
ClinPage is a news website about technologies and services in clinical trials. Its coverage is daily and definitive. Articles and (soon) podcasts at ClinPage showcase thought leaders in the industry.
CTN Best Practices
Clinical Trials Networks Best practices: NIH Road Map
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