SAS and the Clinical Data Interchange Standards Consortium (CDISC) Data standards are a critical component in the quest to improve global public health. Inefficiencies in the collection, processing and analysis of patient and health-related information drive up the cost of drug development for life sciences companies and negatively affect the ...

CDISC (Clinical Data Interchange Standards Consortium) is an organization that develops industry standards. The standards support the electronic acquisition, exchange, and archival of clinical trials data and metadata for medical and biopharmaceutical product development.

The mission of CDISC is “to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.” CDISC standards are promoted as being “vendor-neutral, platform-independent and freely available via the CDISC website.”

As of December 2016, the implementation of CDISC standards, primarily the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), is required for certain studies contained within FDA marketing applications. For the early adapters, this change will have no impact on their current processes.

有关 SAS 临床标准工具包的完整信息， 请访问： http://support.sas.com/rnd/base/cdisc/cst/index.html。 可以在诸如 SAS 生命科学分析等解决方案中有效实施 SDTM 等 CDISC 标准 框架 。

2025年3月14日 · SAS Institute is a global leader in analytics software, and it plays a significant role in the implementation and adoption of CDISC standards. SAS's powerful tools help clinical research organizations manage, analyze, and report data in CDISC-compliant formats, ultimately enabling faster and more efficient drug development processes.

本章中，我们需要受控术语应用于原始数据集source datasets，为了将数据记录和SDTM记录适当的匹配。 上一章称述的codelist metadata文件在这用于生成一个永久SAS Format library，在后续的SDTM conversions过程中使用。 datafile = "D:\SASShare\Data\github\Learning-Implementing-cdisc-using-SAS-\Program\SDTM_METADATA.xlsx" /*datafile的值为：“文件完整路径和文件名”或“libref”*/ . out = formatdata. dbms = excelcs. replace; .

"cfb.sas": 包含宏程序 "%cfb" ， 用于 生成： baseline 值（ 基线是研究人群在前瞻性研究中最开始时的健康状况，是研究对象在接受试验组或对照组干预措施前的“0”时刻。 ）在本程序中，假定：Baseline is defined as the last non-missing value prior to study day 1 first dose;

2023年10月5日 · Writing Dataset-JSON with SAS • PROC JSON in SAS© gives the user control over the JSON output: • through the utilization of options • through the ability to control containers (objects or arrays) • by writing directly to the output file • by choosing exactly what to include or not include in the resulting JSON file