Study Data Tabulation Model, Release 2 (2Nd Informative Ballot) This Document Describes

May 10, 2004

FR:Karen Van Hentenryck

TO:HL7 Membership

RE:2nd Informative Ballot on Study Data Tabulation Model, Release 2

Scheduled ballot open date: June 10, 2004

Scheduled ballot close date: July 10, 2004

The HL7 RCRIM technical committee announces the formation of a ballot group for the following document:

• Study Data Tabulation Model, Release 2(2nd Informative ballot) – This document describes the Study Data Tabulation Model (SDTM), a standardized way to structure data elements for submission to a regulatory authority such as the United States Food and Drug Administration as part of a product marketing application. This document is based on material prepared by the Submission Data Standard (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC). Release 1 of this informative document was balloted and approved as the Clinical Trial Data Regulatory Submission Model in April 2003. Release 1 has also been published by CDISC as the CDISC Submission Data Domain Models Version 3.0.
  The scope of this ballot is limited to changes that have been made since the previous ballot in March 2004, or to derivative problems that may have been created by those changes. The direct changes are clearly marked in the ballot material. (Unique Ballot ID: DATATABMODEL_R2_I2_JUN2004 )

Balloting Procedure

This documentwill be balloted as an HL7 Informative document. HL7 members in good standing and other materially affected parties who wish to participate in this ballot must join the respective ballot group. This can be accomplished via our Web site ( Go to Members Only/Online Voting and locate the heading for this ballot. Beneath the heading is a link that allows you to join the ballot group. Alternately, you can call the HL7 office at (734) 677-7777 and request that the Ballot Group Declaration Form be faxed or mailed to you.

HL7 will conduct this ballot according to its procedure for electronic balloting. Members of the ballot group will not receive a paper copy of the document or a paper ballot. Instead, they will be notified by e-mail when the ballot package is available. They will download the document from the HL7 Web server and will enter their votes and comments using the HL7 Web server.

If a member of the ballot group does not have access to the technology being used, or if the person can demonstrate that using the electronic process creates a substantial hardship, he/she may request a paper copy of the ballot package and/or vote using a paper ballot. Because of the extra expense and time delays associated with paper ballots, HL7 does not intend to provide the alternative of using paper to members who have access to the technologies and have no substantial hardship associated with their use.

Comments received in response to this ballot will be addressed by a ballot reconciliation committee of the HL7 Regulated Clinical Research Information Management (RCRIM) technical committee. Responses will be distributed on the RCRIM listserver, sent to individuals in the ballot pool, and posted in the RCRIM minutes area at the HL7 website ( on or before 19 July 2004. Reconciliations will be discussed on the regularly scheduled RCRIM teleconference scheduled for 23 July 2004, and the committee will vote on accepting the reconciliations during the regularly scheduled RCRIM teleconference scheduled for 6 August 2004. To attend either teleconference, phone 703-788-0600 and enter passcode 236263# when requested. Long distance charges will apply to this call.

Summary of Schedule (see above for details):

Ballot Open: June 10, 2004

Ballot Close: July 10, 2004

Reconciliation Responses Published: July 19, 2004

Discussion of Reconciliation Responses: July 23, 2004 (teleconference)

Vote on Reconciliation Responses: August 6, 2004 (teleconference)