Best Practices For Data Standards Implementation

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Project Overview

CDISC standards and the documentation around them have come a long way since they were first introduced, but plenty of ambiguity still exists. In some cases, implementation guidelines dedicate space to such subjects, but the subjective nature with which the reader is left can sometimes lead to further questions. In other cases, gaps are not sufficiently addressed, and sometimes are omitted entirely. In any case, uncertainties can lead to the submission of data with limited usefulness.

The scope of this project is defined as the identification of several of these gray areas, and the publication of a Best Practices document for each. This project will pick up where the Data Quality group left off in 2013 with the publication of Best Practices for Data Set Sizing, drawing on some of the successes of that effort (e.g. document template). Ideas for topics will come from industry participants as well as the FDA.

The group has split into three teams to publish three sets of Best Practice documents in the first half of 2014. In August, the group will re-convene to decide on a second set of topics to be published by the end of the year. Subgroups will agree on a timeline for meeting and discussing their topic, and the whole group will meet regularly to discuss progress and other issues that come up in the subgroups.

Note: This group has no intention of defining new rules and requirements. For any given topic, an initial draft will be produced and published, and an open comment period will be defined to provide opportunity for feedback. Final documents will be based on all feedback provided through the comment forum as well as other means.


Project Leads

Name Role Organization E-mail
Mike Molter Industry Co-Lead d-Wise mike.molter@d-wise.com
Lisa Lyons Industry Co-Lead Janssen LLyons3@its.jnj.com

Project Updates

Objectives and Timelines

Objective Timeline
First draft published to wiki for public comment for each sub-team (first half topics) July 31, 2014
Final draft published to wiki for each sub-team (first half topics) August 31, 2014
First draft published to wiki for public comment for each sub-team (second half topics) December 31, 2014
Final draft published to wiki for each sub-team (second half topics) January 31, 2015

Project Content and Activities

Meeting Minutes

Best Practice Leadership Minutes 2014

Archived Content


Sub-Team Projects

Below are the links to the wiki pages for each of the sub-team projects for the first half of 2014.

Lab Units

USUBJID

VISITNUM and EPOCH