CDISC Electronic Submission? Here Are How and What to Prepare

• Activity Number: 313
• Type: Contributed
• Date/Time: Tuesday, August 6, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Kevin Lee*+
• Companies: Cytel
• Keywords: CDISC ; electronic submission ; FDA ; eCTD ; NDA ; SDTM

Abstract

The paper is intended for statisticians who need to prepare CDISC electronic submission to the agency. In this paper, we will begin with where statisticians can find FDA electronic submission guidelines and CDISC guidelines such as eCTD(electronic common technical document) specification, SDTM implementation guideline, ADaM implementation guideline and etc.

First, we will provide the brief introduction of regulatory electronic submission such as its methods, five modules in CTD especially m5, technical deficiencies in submission and etc. And, according to FDA and CDISC guidelines we will discuss what are submitted to FDA like CSR, Protocol, SAP, SDTM annotated eCRF, SDTM datasets, ADaM datasets, ADaM datasets SAS Programs and Define.xml.

And secondly, we will discuss how statisticians prepare the submitted materials; for example, length and naming conventions of electronic files and file formats for electronic files, SAS data sets and SAS programs. Lastly, we will discuss about the latest FDA concerns and issues about the electronic submission such as the size of SAS data sets, the length of character variables in SAS datasets, CDISC compliance checks and etc.