Tag: CDISC

Creating Custom or Non-Standard CDISC SDTM Domains

Here is the nice article about creating custom SDTM domains………

Creating Custom or Non-Standard CDISC SDTM Domains

Within the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), standard domai…

Is There Any Better Way? Publishing Process For CDISC Standards

  1. The Pain I read from Lex Jansen (@LexJansen) that CDISC SDTM v1.3 and SDTMIG v3.1.3 were newly released. It’s pretty nice since CDISC SDTM was supposed to be released semiannually in the new publishing cycle. We can see the team put great efforts on this new version, but frankly speaking, this delivery (the […]

Blogging is Awesome: CDISC Bloggers

I remember when blogging was cool. Before the specializing and monetizing and Twitter-izing.                                       —Peter Dewolf Well I think blogging is still cool (and awesome and awesome …). The most appealing personal reason is, blog posts are Google searchable and suitable for archive while Tweets NOT. Admittedly I hold some sort of  Existentialism 2.0: if […]

OpenCDISC Validator V1.3: An Unboxing Review (1): counting issue

The lasted OpenCDISC Validator version 1.3 was released at 29 March, 2012 (btw, there is a typo in the Line 1 of CHANGELOG.txt within the package: “2012” not “2011”). As usual, you can submit the following SAS scripts to get some basic information(remember to customize your directory): filename CDISC url "https://raw.github.com/Jiangtang/Programming-SAS/master/Rules_Count_OpenCDISC_XML.sas"; %include CDISC; %Rules_Count_OpenCDISC_XML(dir=C:\OpenCDISC1.3\compare\opencdisc-validator_1.3\config) and […]

Fetch CDISC Control Terminology Files in NCI Vocabulary Repository: All in One Click

CDISC Control Terminology is the most frequent updated model among CDISC standards. Take SDTM as example, the latest SDTM terminologies released at 23 March 2012; and from 2009 to 2011, there were 15 different SDTM terminology versions! If you just rely on your own local repository, you might miss the pace somehow. Here is a […]

Quick Notes on RTP CDISC User’s Group Q1 Meeting

It’s my first time to attend a local event, RTP (Research Triangle Park) CDISC User’s Group meeting, Q1 and here are some quick notes. 1. people Almost fresh faces for me. It’s nice to meet Jack Shostak of Duke Clinical Research Institute again. I visited him in Duke last year after SAS Global Forum in […]

GitHub and Weekend Programming

Yihui of Iowa State just texted me that GitHub is programmers’ Facebook. Inspired by him(great thanks!), I also begin to play with GitHub now: https://github.com/Jiangtang Currently I only created one repo as personal SAS code repository. To kill weekend time, I uploaded piece of codes to count the OpenCDISC validation rules by models. To use […]

Face Off: Review OpenCDISC XML files

OpenCDISC, the first open source CDISC validator, is already in the toolbox of FDA reviewers (CDER/CBER, see CDISC Standards in the Regulatory Submission Process, 26 January 2012, P.33). The key features in OpenCDISC is a dichotomy of validation rules (XML based) and application logic. Currently OpenCDISC Validator (Version 1.2.1) officially supports the four following CDISC […]