Home / FDA CDER Data Standards Plan V 1.0 and PDUFA IV IT Plan Update Released By Dr. Rebecca Kush

Two new documents relevant to CDISC have now been posted to the FDA
website and one announced in the Federal Register.  In this blog are a
few highlights that I have pulled from each of the documents…but, please
read them yourselves and  please sign up to attend the webinar on
29 June to hear directly from CBER and CDER representatives, Amy Malla
and Dr. Chuck Cooper


At the end of this blog, I have included a list (not exhaustive) of the activities FDA CDER and CBER have initiated recently to demonstrate that they are serious in executing the new Data Standards Plan.

CDER Data Standards Plan – Version 1.0

SUMMARY (from the FR Notice): “The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft document entitled ‘‘CDER Data Standards Plan Version 1.0’’ (draft plan). The draft plan outlines the general approach proposed for development of a comprehensive data standards program in the Center for Drug Evaluation and Research (CDER). The draft plan identifies key objectives for a data standards program at CDER, processes to be developed to ensure successful use of those standardized data, and a set of recommended projects to begin in calendar year (CY) 2010.

DATES: Submit either electronic or written comments on the draft plan by September 15, 2010.”

The Introduction of the draft CDER Data Standards Plan states:

  1. “The lack of standardized data affects CDER’s review processes by curtailing a reviewer’s ability to perform integral tasks such as rapid acquisition, analysis, storage and reporting of regulatory data. 
  2. Standardization of data submissions, a requirement for electronic submissions, and a robust computational infrastructure would make significant improvements possible.
  3. The objectives of the data standards plan are to establish a comprehensive data standards program at CDER, ensure development of data standards for all key data needed to make regulatory decisions, and ensure successful use of those standardized data.”

On page 11 is a paragraph stating“The current version of the PDUFA IT plan has caused confusion and concern among both external and internal stakeholders because it implies a shift to the submission of study data formatted in accordance with CDISC-HL7 standards within the next few years.  This impression is not correct. Neither the HL7 standards, nor the Agency, nor regulated industry are ready for such a transition.”  (From the PDUFA IV IT Plan Update—see below: “CDER and CBER will continue refining, improving and expanding the use of CDISC standards for regulatory submissions for the process of human drug review through FY 2013 and beyond.”)


On page 19 (Figure 2) of the CDER Data Standards Plan is a diagram showing Development of Disease-specific Data Standards Through Collaboration between FDA and CDISC.   Such standards will augment CDISC SDTM, CDASH and Terminology so that efficacy data have a place in submissions (i.e. not just putting important data into SUPPQUAL).

There is a Charter for the CDER Data Standards Program Board in Appendix A.

Important Links:

CBER has indicated that they will be publishing a Data Standards Plan that is in sync with that of CDER, but meeting specific needs for CBER.

Updated PDUFA IV IT Plan

In the updated PDUFA IV IT Plan, there is a section on pages 14-16 (5.4 Data Standards) that describes the CDER and CBER plans and their data standards management needs, referencing the CDER’s Data Standards program and the CBER and CDER needs. 

Specifically, it states: “In addition to these principles (standards management at the FDA), which apply to the standards at the FDA, a general approach has been identified for the management of data standards within CDER and CBER.  With an increasing volume of submissions, CDER and CBER must transition to standardized electronic regulatory submissions in order to meet strict regulatory deadlines. In order to adhere to the Centers’ data standards management programs, projects and activities should adhere to the following three guiding principles (shortened for the purpose of this blog so please read the document):

  • Projects should be focused on addressing end-user requirements.
  • Data standards projects and activities should be focused on concrete near-term improvements that benefit pre-market drug review and other regulatory functions. 
  • Data standards-related decisions and standards-related processes should be clear, predictable, and widely communicated in a timely manner.


In this Data Standards section of the PDUFA IV IT Plan on page 16, there are paragraphs reading:

  • “User Acceptance Testing and Adoption represent phases critical to the ultimate success and value of a developed standard. FDA is currently developing a more comprehensive data standards lifecycle management template to structure and help support this process.”
  • “FDA works with its end-user community and the appropriate SDO or terminology standards maintenance organization to update the standard as needed…..CDER and CBER will continue refining, improving and expanding the use of CDISC standards for regulatory submissions for the process of human drug review through FY 2013 and beyond.”
  • In order to begin a center-wide process that is clear, predictable and aggressive in advancing the availability and utility of data standards and standardized data submissions, the Centers need to establish procedures and baseline capabilities.” (The document provides four specific procedures here.)


Page 27:  “While the FDA DSC pursues continued longer-term development of HL7 study data standards, as a near-term strategy to support drug review, CDER and CBER are re-evaluating the benefits of pilot testing an ODM based eCRF.”


Link to Prescription Drug User Fee Act (PDUFA) IV IT Plan

Relevant FDA Activities

Significant steps that CDISC has observed working with CDER and CBER since last fall include not only the development and release of this CDER Data Standards Plan and update to the PDUFA IV IT Plan but also:

  • an invitation for CDISC to present at the PDUFA V hearings last April
  • acceptance of eSubmissions using SDTM by CBER beginning last month 
  • the initiation of regular teleconferences with FDA CDER and CBER representatives regarding ongoing data standards activities within CDISC and NCI that are relevant to these centers
  • the planning of an Oncology Workshop to engage reviewers from the oncology division to work with CDISC, NCI and others on the oncology-specific standards 
  • a request to vet certain FDA cardiovascular disease data elements through the CDISC process
  • request for CDISC training of reviewers within CBER (training in CDER has been ongoing for over a year now)
  • release of FDA RFPs for assistance in converting legacy data to SDTM and working with CDISC to augment the CDISC standards as needed with therapeutic-area specific (efficacy) standards
  • participation with Critical Path Institute in the Coalition Against Major Diseases, which has used CDISC standards extensively to be able to aggregate data across organizations. 


We were told by CDER representatives that the CDER Data Standards Plan is a starting point to build the infrastructure that is necessary to support eSubmissions with standard data formats to improve reviews.  It will be expanded and more details will come. 

So, PLEASE listen to the webinar on 29 June, read the documents and comment on the CDER Data Standards Plan, and join CDISC to support the progress.  And, don’t forget to start your new research studies by collecting data in CDASH format (only mapping at the back-end when necessary).  OR, request that your CRO or vendor supports CDISC standards.  This will ensure  that your companies can reap the most value from the CDISC standards from the beginning (Protocol and CRFs) through eSubmission.