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Regulatory Documents (FDA, EMA, PMDA, etc.)

CDISC updates this page regularly with announcements from the regulatory authorities, however readers should check for new announcements directly with the agency concerned.

 

Announcements:

 

  • A new document about CDER Data Standards has been posted on the FDA website. Please click here to access to document directly.

Latest Updates

FDA Study Data Specifications

Latest version of FDA Study Data Specifications has been released, announcing support for SDTM V3.1.2

Additional Resources can be found here.

 

The FDA eCTD guidance, which includes SDTM as part of the data specifications, was released as final in April 2006 and revised in June 2008.

Since then the FDA has completed a thorough economic impact review and posted a NPRM (notice of proposed rule making) in May 2008 that they expected a further announcement in October 2008. So far no new announcements have been forthcoming but CDISC have been told that FDA is not allowed to say anything about a rule that is being developed once that process starts.

The latest information in the eCTD guidance is that the Study data specification was updated in November 2009 to allow for 3.1.2 of the SDTM to be submitted.

For the latest information on eCTD click here.

 

About eSubmissions to FDA

  1. The FDA is dedicated to improving the efficiency and effectiveness of
    receiving and evaluating regulatory submissions and safety assessments.
  2. The
    FDA has issued the Final Guidance on eSubmissions (eCTD), which
    provides reference to the CDISC SDTM as a Study Data Specification when
    providing electronic submissions to FDA.
  3. A regulation is being
    proposed that will require all regulatory submissions in electronic
    format and the use of CDISC SDTM. There will be an appropriate period
    of time allowed for compliance with this regulation.
  4. The FDA is
    working with CDISC and HL7 on transport technologies that may
    ultimately replace the current SAS file method used for submissions
    today (see below).
  5. Regardless of the transport technology, the
    FDA is committed to using SDTM for content and for evaluation of
    eSubmissions by regulatory reviewers. 

CDISC Content to Message Project

FDA,
in close collaboration with CDISC, is engaged in a project to develop
XML messages for CDISC content that is based on the HL7 RIM (Reference
Information Model). The project scope is to create four HL7 V3 messages
from existing content within the CDISC standard that can ultimately be
balloted in HL7.

The project involves using the BRIDG
(Biomedical Research Integrated Domain Group) domain analysis model.
This model is used by both CDISC and the HL7 RCRIM TC (Regulated
Clinical Research Information Management Technical Committee) to
harmonize standards and ensure semantic interoperability. CDISC is in
charge of the content and business requirements and harmonization of
the components of the CDISC standard into the BRIDG model. FDA is
responsible for modeling and message development. These two streams
will work in parallel with close collaboration and interaction.

A CDISC-HL7 Project Document has been produced by CDISC and FDA and presented to HL7 RCRIM.

For additional information, see the FDA Data Standards Council's website's CDISC Data Standards web page.