Tag: openCDISC

What’s New

I didn’t blog for a while in this first half March and there are bunches of new stuff to catch up: I had a new baby! He was delivered on time (and on budget!), lions tigers and bears, oh my… His brother is Tiger so I named him, Leo. And I got the latest SAS […]

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 […]

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 […]

SDTM Compliance Checks

Validation checks or tools to check the compliance of SDTM data

JANUS is a standard database model which is based on the CDISC’s SDTM standard. JANUS is used by the FDA to store the submitted SDTM clinical data. As a part of data definition f…

SDTM Compliance Checks

Validation checks or tools to check the compliance of SDTM data

JANUS is a standard database model which is based on the CDISC’s SDTM standard. JANUS is used by the FDA to store the submitted SDTM clinical data. As a part of data definition f…

SDTM Compliance Checks

Validation checks or tools to check the compliance of SDTM data

JANUS is a standard database model which is based on the CDISC’s SDTM standard. JANUS is used by the FDA to store the submitted SDTM clinical data. As a part of data definition f…