SEND clinical trial

SEND clinical trial

SEND (Standard for Exchange of Non-Clinical Data)

The Standard for Exchange of Non-Clinical Data (SEND) is an implementation of the Study Data Tabulation Model SDTM for non-clinical studies. These types of studies are typically related to animal testing as part of pre-clinical (pre-Phase 1) clinical trials.

This standard was developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND Team, which is committed to establishing a standard that can be used for the exchange and submission of non-clinical data collected from animal toxicology studies.

The work on this standard began in July 2002—subsequently, an FDA pilot project was initiated in July 2003 through a Cooperative Research and Development Agreement (CRADA). Feedback from this pilot and continuous efforts to more closely align this implementation with the SDTM for human clinical trials led to development of the current version, SEND v2.3, which covers single-dose, repeat-dose, and carcinogenicity studies.

References:

http://www.fda.gov/oc/datacouncil/send.html


Wikimedia Foundation. 2010.

Игры ⚽ Поможем написать реферат

Look at other dictionaries:

  • Clinical trial — Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be… …   Wikipedia

  • JANUS clinical trial data repository — is a clinical trial data repository (or data warehouse) standard as sanctioned by the Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see… …   Wikipedia

  • Clinical Data Interchange Standards Consortium — (CDISC) is a non profit organization, whose mission is to develop and support global, platform independent data standards that enable information system interoperability to improve medical research and related areas of health care . Their main… …   Wikipedia

  • Clinical data management system — A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the… …   Wikipedia

  • Clinical Data Interchange Standards Consortium — Das Clinical Data Interchange Standards Consortium (kurz CDISC) ist eine Non Profit Organisation (Gemeinnützige Gesellschaft) mit Sitz in Austin im US Bundesstaat Texas. CDISC entwickelt eine Reihe von offenen Standards für den Austausch von… …   Deutsch Wikipedia

  • List of clinical research topics — Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. Contents 1 General topics 2 Drug terminology 3 T …   Wikipedia

  • Health and Disease — ▪ 2009 Introduction Food and Drug Safety.       In 2008 the contamination of infant formula and related dairy products with melamine in China led to widespread health problems in children, including urinary problems and possible renal tube… …   Universalium

  • Life Sciences — ▪ 2009 Introduction Zoology       In 2008 several zoological studies provided new insights into how species life history traits (such as the timing of reproduction or the length of life of adult individuals) are derived in part as responses to… …   Universalium

  • Medicine in medieval Islam — In the history of medicine, Islamic medicine or Arabic medicine refers to medicine developed in the medieval Islamic civilization and written in Arabic, the lingua franca of the Islamic civilization. Despite these names, a significant number of… …   Wikipedia

  • Diabetes management — Main article: Diabetes mellitus Diabetes is a chronic disease with no cure as of 2010[update] but a lot of research is underway. It is associated with an impaired glucose cycle, altering metabolism. Management of this disease may include… …   Wikipedia

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”