Contents
About
Before You Begin
Introduction
Purpose
Assumptions and Notes
The Standards in This Document
Internal Validation
Installation Qualification and Operational Qualification
Introduction
Steps
Sign-Off
ODM
Test 1: Create SAS ODM from XML
Introduction
Steps
Sign-Off
Test 2: Validate SAS ODM
Introduction
Steps
Sign-Off
Test 3: Create ODM XML from SAS ODM
Introduction
Steps
Sign-Off
Test 4: Find Unsupported Tags in ODM XML
Introduction
Steps
Sign-Off
CRT-DDS
Test 1: Validate CRT-DDS
Introduction
Steps
Sign-Off
Test 2: Create SAS CRT-DDS from SDTM
Introduction
Steps
Sign-Off
Test 3: Create SAS CRT-DDS from Define.xml
Introduction
Steps
Sign-Off
Test 4: Import from XML, Export to XML (Round Trip)
Introduction
Steps
Sign-Off
Test 5: Create Define.xml
Introduction
Steps
Sign-Off
SDTM
Test 1: Validate SDTM
Introduction
Steps
Sign-Off
Test 2: Build Source Data
Introduction
Steps
Sign-Off
Test 3: Build Source Metadata
Introduction
Steps
Sign-Off
Test 4: Build SAS Formats
Introduction
Steps
Sign-Off
Test 5: Report Check Metadata
Introduction
Steps
Sign-Off
Product
Release
SAS Clinical Standards Toolkit
Type
Installation
Copyright Date
April 2013
Last Updated
07May2013