The Use of CDISC Data Standards in FDA Electronic Submissions

The preferred format for submitting standardized study data to CDER and CBER are the Clinical Data Interchange Standards Consortium (CDISC) Foundational Standards, including the Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Standard for Exchange of Nonclinical Data (SEND). In 2011, approximately 30% of unique NDAs received by CDER and approximately 20% of BLAs received by CBER included CDISC/SDTM data....

Read More

New FDA Study Data Specifications Differentiate Between SDTM, Legacy Formats

In January, FDA issued version 1.5.1 of Study Data Specifications. As discussed in my previous blog entry, a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered to indicate whether they were STDM or legacy format. The new specifications for organizing study datasets and their associated files in folders are summarized in the...

Read More

Specifications for Organizing Study Datasets

A few months ago, FDA issued version 1.5.1 of Study Data Specifications. Although the changes in the new version were not great, they were significant for eCTD as a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered and has no effect on the Table of Contents that is visible to a reviewer (created from the eCTD XML backbone)....

Read More

Lack of Standardized Data Hurting Review

This week’s blog posting is from Laura Wright, who attended the 23rd Annual DIA EDM conference in National Harbor, MD, February 16 through 19. In Laura’s role as Account Manager at GlobalSubmit, she talks to many people in regulatory, clinical and IT roles in the biopharmaceutical industry. Hearing some of their interests and concerns led Laura to attend a session entitled “Regulatory Update: Future Directions”. Here, she offers her...

Read More