Study Data Standards for Submission to CDER
CDER strongly encourages IND sponsors and NDA applicants to consider the implementation and use of data standards for the submission of applications. Such implementation should occur as early as possible in the product development lifecycle, so that data standards are accounted for in the design, conduct, and analysis of studies. These resources are intended to assist submitters in the preparation and submission of standardized study data to CDER. This webpage will be updated regularly to reflect CDER's growing experience in order to meet the needs of its reviewers.
- CDER Data Standards Common Issues Document Updated Version 1.1, December 2011 (PDF - 104KB) - The goal of this document is to communicate general CDER preferences and experiences regarding the submission of standardized data to aid sponsors in the creation of standardized datasets. The 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 compliment and facilitate the interaction between sponsors and divisions.
- Study Data Specifications (v2.0) (PDF - 96KB) - Study specifications for submitting animal and human study datasets in electronic format
- CDISC Study Data Tabulation Model (SDTM)
- SDTM Implementation Guide for Human Clinical Trials (SDTM IG) - Developed by the Clinical Data Interchange Standards Consortium (CDISC), the SDTM IG is an implementation of the SDTM for clinical study data. The conceptual model and SDTM IG can be obtained from the CDISC web site at: http://www.cdisc.org/sdtm
- Standard for Exchange of Nonclinical Data Implementation Guide (SEND IG) - Developed by the Clinical Data Interchange Standards Consortium (CDISC), the SEND IG is an implementation of the SDTM for data collected from animal toxicology studies.
- The production version of the SEND Implementation Guide (IG) Version 3.0 (SEND IG v3.0) is NOW available at http://www.cdisc.org/send
- CDISC Analysis Data Model (ADaM) - Developed by the Clinical Data Interchange Standards Consortium (CDISC), ADaM is an analysis dataset standard accepted by CDER. The Model and Implementation Guide can be obtained from the CDISC web site at: http://www.cdisc.org/adam
- Questions regarding datasets should be forwarded to the CDER eDATA team at firstname.lastname@example.org.