2010年11月17日 · This document discusses CDISC standards for representing survival data from oncology clinical trials. It provides an overview of CDISC and describes the SDTM and ADaM domains that are useful for capturing efficacy endpoints involving survival, such as overall survival, progression-free survival and tumor response.

2014年9月7日 · Whatis CDISC A world of Standards CDISC in submission WhatNext TheClinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, not-for-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

2014年11月2日 · This document discusses CDISC standards for representing survival data from oncology clinical trials. It provides an overview of CDISC and describes the SDTM and ADaM domains that are useful for capturing efficacy endpoints involving survival, such as overall survival, progression-free survival and tumor response.

2014年9月19日 · Background • CDISC: Clinical Data Interchange Standards Consortium • SDTM: Study Data Tabulation Model • standard for interchange of collected data • submitted in Item 11 • ADaM: Analysis Data Model • standard for interchange of analysis data • submitted in SRA (Statistical Review Aid)

2017年3月5日 · CDISC 数据库注释 Special-Purpose Domains: DM – 受试者人口学资料（性别、年龄、种族、出生日期、国家、中心号、医生姓名等） CO – 注释（非异常描述、其它发现的注释） Interventions: CM – 伴随用药记录和其它物理治疗 EX – 试验用药记录 SU – 物质使用（烟、酒 ...

CDISC operates to advance the continued improvement of public health by enabling efficiencies in medical research and related areas of healthcare. Strength through collaboration.

2014年8月6日 · CDISC has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical research data and metadata to improve data quality and streamline medical and biopharmaceutical product development and research processes • Consensus-based development (COP-001) • Standards are freely ...

2017年2月23日 · This document provides an overview of CDISC (Clinical Data Interchange Standards Consortium) and SDTM (Standard Data Tabulation Model). It defines these standards, their purpose in establishing common data formats for clinical research, and key concepts in SDTM like domains, variables, qualifiers and time standards.

A CDISC data standard is any product (including specifications, user guides, implementation guides, models or schemas) provided by CDISC that describes representation of clinical* research data and has been properly developed, vetted and approved through the …

Using the clinical features and basic concepts of clinical trials, this course shows how to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, to validate the structure and content of the clinical ...