FDA: CDER Data Standards Program – First Periodic Assessment & OpenCDISC Validator Updates

In 2010, The Center for Drug Evaluation and Research (CDER) developed a comprehensive data standards plan to support and develop the advanced data standards within the Center and Agency, and with industry stakeholders. The CDER receives an enormous and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. The lack of robust exchange, content and terminology standards for these data impacts the efficiency of CDER’s review processes by curtailing a reviewer’s ability to perform integral tasks such as rapid access, analysis, storage and reporting of regulatory data.

The CDER has released the First Periodic Assessment of CDER’s Data Standards Plan document. This document describes the current status and the future plan.

Please use the below mentioned weblink to download the First Periodic Assessment of CDER’s Data Standards Plan document.

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM287409.pdf

Study Data Validation Rules are available for download.

OpenCDISC Validator

OpenCDISC Validator is a collaborative project to develop an open source, freely available, and commercial-quality tool for ensuring clinical data compliance with CDISC standards, including SDTM, ADaM, SEND, Define.xml, and others. The Validator’s key strength is its architecture that separates validation rules from application logic. The driver behind this design decision was to provide users the ability to keep up with evolving standards, sans the need to update and re-validate application logic. The validation rules are defined using XML-based validation framework with power to specify a wide range of rules and flexibility to support near-SDTM, SDTM+, and even custom datasets.

Validator's Key Features

• Metadata driven and configurable
• Validation rules and messages stored in XML
• Facilitates compliance with all CDISC models
• Supports SDTM v3.1.2 and v3.1.1
• Checks against SDTM specification, controlled terminology, and Define.xml
• Configurable to handle SDTM+ and near-SDTM datasets
• Companies can create own standard configurations and share with partners
• Detailed reporting in Excel, CSV, and HTML
• Requires no installation, just unzip and use
• Compact and portable, will even run off a USB flash drive
• Deploy it on a server or hosted environment to share company-wide
• Easy to integrate with existing systems and processes
• Built 100% open source, 100% Java
• Can run in a validated environment
• Commercial support available

To find more information about the validator and to download please use the below mentioned weblink

http://www.opencdisc.org/projects/validator