Source: FDA (Version 1.1/December 2011)
The Center for Drug Evaluation and Research (CDER) is strongly encouraging sponsors to submit data in standard form as a key part of its efforts to continue with advancement of review efficiency and quality. CDER has been collaborating with CDISC, a standards development organization (SDO), in the development of standards to represent study data submitted in support of regulatory applications. Study data standards are vendor-neutral, platform-independent, and freely available via the CDISC website (http://www.CDISC.org). CDISC study data standards include SDTM (Study Data Tabulation Model) for representation of clinical trial tabulations, ADaM (Analysis Data Model) for clinical trial analysis files, and SEND (Standard for Exchange of Non-clinical Data) for representation of nonclinical animal toxicology studies tabulations.
CDER has accepted SDTM datasets since 2004; however, due to differences in sponsor implementation of the standard, CDER has observed significant variability in submissions containing “standardized” electronic clinical trial data. CDER has received numerous “SDTM-like” applications over the past several years in which sponsors have not followed the SDTM Implementation Guide. Furthermore, aspects of particular sponsor implementations have actually resulted in increased review difficulty for CDER reviewers. In addition, some sponsors have wrongly believed that the submission of SDTM datasets obviates the need for the submission of analysis datasets, resulting in the delay in review due to the need to request these datasets. The goal of this document is to communicate general CDER preferences and experiences regarding the submission of standardized data in order to aid sponsors in the creation of standardized datasets for both tabulation datasets and analysis datasets. .
This document is not intended to replace the need for sponsors to communicate with review divisions regarding data standards implementation approaches or issues, but instead, it is designed to complement and facilitate the interaction between sponsors and divisions. Because of specialized needs in different divisions, it is likely that divisions may have additional requests or preferences. When uncertainty exists regarding a particular data standards implementation or submission issue, the sponsor should contact the review division to discuss further.
The complete documentation on CDER data standards in .pdf version can be found at the following link: CDER
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.