**StudySAS Blog: Mastering Clinical Data Management with SAS**

Yesterday, FDA published its first official list of validation rules for CDISC SDTM. These long awaited rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis. For Official list of rules, here is the direct link for the FDA website: http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm The FDA is asking sponsors to validate their study data before submission using these published validation rules and either correct any validation issues or explain, why they could not be corrected, in the Study Data Reviewer's Guide. This recommended pre-submission validation step is intended to minimize the presence of validation issues at the time of submission. Open CDISC is offering a webinar on the official list of validation rules. They are offeri...

Clinical Trials/Studies in Humans The clinical testing (investigation) of experimental drugs (previously unproven in humans, therefore "experimental") in humans is normally done in three phases (Phase I, II and III) with more and more people included in each subsequent phase. Before moving to the next phase of development the data are carefully analyzed to ensure the experimental drug is at least safe and well tolerated. After successful completion of Phase I-III testing, a company will submit the results of all of the studies to the FDA or TPD to obtain a New Drug Approval (NDA). Once the FDA or TPD grants a company with a NDA, the company can market the drug (medication) to the public. Additional testing (post-marketing or late phase III/phase IV) to look at the ongoing-term safety continues. Phase I Studies Phase I studies are primarily concerned with the drug's safety, and are the first time the drug is tested in humans. These studies are typically done in a ...

An Introduction to CDISC: CDISC: Why SAS® Programmers Need to Know CDISC Implementation Step by Step: A Real World Example A Toolkit for CDISC Implementation CDISC standards How to test CDISC Operation data Model (ODM) in SAS Creating Case Report Tabulations (CRTs) for an NDA Electronic Submission to the FDA Implementation Guide Study Data Tabulation Model Update on CDISC Study Data Tabulation Model Practical Methods for Creating CDISC SDTM Domain Data Sets from Existing Data SAS® Dataset Content Conversion to CDISC Data Standards IMPLEMENTATION OF CDISC STANDARDS Sample CRF's and Protocol CRFs (PDF - 773.4 KB) Protocol (PDF - 2.0 MB) direct link: https://biolincc.nhlbi.nih.gov/studies/

Why is the adoption of the CDISC standards important for the life sciences industry and what is SAS' relationship with CDISC? A: The Clinical Data Interchange Standards Consortium (CDISC) is fundamentally changing the way information is being managed in the life sciences research industries, and is beginning to change the way the US Food and Drug Administration (FDA) reviews new drug applications. Historically, most pharmaceutical organizations developed their own internal data standards, and associated processing, for managing research information. Each organization's unique approach to this information management process has done little to expedite the overall new drug development process, and in many ways has slowed it down - by requiring each organization to spend unnecessary effort acquiring, developing and implementing distinct processes. Furthermore, the submission of research data in nonstandardized formats makes it difficult for the FDA to develop standard, efficient, ...