Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 107 countries, as well as standards issued by a number of international and regional organizations. The standards address such issues as informed consent, research ethics committee review, reporting requirements, vulnerable populations, and more.
Three new countries are spotlighted in the 2014 edition: Cameroon, Mozambique, and Zambia. The 2014 edition also includes hundreds of updates from the 2013 edition.
The listings are organized into seven categories:
Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.