Metadata Definition Project

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Project Overview

The project focuses about developing common definitions around metadata and related aspects across the industry. There is indeed a lot of confusion around what is operational and structural metadata versus master data, code list versus code systems and value sets. We intend to develop industry-wide definitions – to be potentially re-used in the FDA guidelines – with some concrete, practical example to help people introduce these concepts correctly within their organisation. This six-month project will initially meet bi-weekly for one hour, for the first three months

Project Leads

Name Role Organization E-mail
Isabelle deZegher Industry Co-Lead Paraxel Isabelle.deZegher@parexel.com
Mitra Rocca FDA Co-Lead FDA Mitra.Rocca@fda.hhs.gov
Marcelina Hungria Industry Co-Lead DIcore Group, LLC mhungria@dicoregroup.com

Project Members

Name Organization E-mail
Terek Peterseon PRA International PetersonTerek@PRAIntl.com
Marcelina Hungria DIcore Group mhungria@dicoregroup.com
Susan Zhao Medivation susan.zhao@medivation.com
Yun Oldshue Takeda yun.oldshue@takeda.com
Sam Hume CDISC shume@cdisc.org
Tim Church Torch tim.church@torch.uk.net
Kenneth Stolzfus Accenture kenneth.m.stoltzfus@accenture.com
Julie James Blue Wave Informatics julie_james@bluewaveinformatics.co.uk
Praveen Garg ICON Praveen.Garg@iconplc.com
Aimee Basil Celgene abasile@celgene.com

Project Updates

Teleconference: Occurs weekly on Wednesdays, 11:00 am -12:00 pm EST, 5:00 - 6:00 pm CET Kick-off meeting for the meta data management workgroup was held on Friday, 17May2013


WebEx Details: https://parexelmeetingcenter.webex.com/parexelmeetingcenter/j.php?J=591767494 Meeting Number: 591 767 494
Call-in Numbers: +44-207-8973622 (United Kingdom) 1- 855-225-1640 or 1-253-336-6983(US) Show global numbers: https://www.tcconline.com/offSite/OffSiteController.jpf?cc=6896760617 Conference Code: 689 676 0617


Objectives and Timelines

Objective Timeline
Read definition in the draft metadata definition document and provide comments June 2013
add definition for

• Study instance metadata
• Standards metadata
• Semantic metadata
• Process metadata (included in descriptive metadata)

June 2013
Develop definition for interoperability June 2013
provides examples on meta metadata June 2013
Develop definitions for data element, data type, attribute and class July 2013
Develop definitions for meta data registry and metadata repository July 2013
Develop definitions and examples for controlled terminologies July 2013
Develop definitions and examples for controlled terminologies August 2013
Presentation on controlled terminologies, code systems and value set by Julie James September 2013
Stared with Value Level Metadata (VLM) and also worked on controlled terminology section October 2013
Continued with Value Level Metadata (VLM), finalizing the controlled terminology section and starting with master data management November 2013
Started with the master data management section, discussed differences between master data and reference data December 2013
Continued with the master data management section, and started the interoperbility section January 2014
Finished the interoperability section as well as the master data management, started with data pooling, aggregation and integration sections February 2014
Finished the data pooling, aggregation and integration sections, addressed comments from the team members who have reviewed the meta data definition document. In addition finalized the presentation to the FDA/PhUSE CSS conference March 2014
Continued to review the metadata definition document; developed comments and submitted them to the FDA technical guidance April 2014
The team members reviewed the metadata definition document and the comments were incorported into the final document May2014

Project Activities

To be of operational value, the metadata definition document contains not only definitions but also a short description and example of use. Whenever possible, the definitions are built from those existing definitions from FDA guidance's, CDISC glossary, check cross industry definition (e.g. Gartner). Reference to the source definition is provided.


Meeting Materials

Date Document Type Document
15 July 2014 Final Document Metadata Definitions Document
28 May 2014 Document Metadata Definitions Document
21 May 2014 Document Metadata Definitions Document
14 May 2014 Document Metadata Definitions Document
14 May 2014 Meeting Minutes Metadata Definitions Document
30 April 2014 Document Metadata Definitions Document
09 April 2014 Document Metadata Definitions Document
23 March 2014 Document Metadata Definitions Document
12 March 2014 Document Metadata Definitions Document
12 March 2014 Presentation Metadata Definition Presentation
26 February 2014 Working Document Metadata Definitions Document
26 February 2014 Meeting Minutes Meeting Minutes
19 February 2014 Working Document Metadata Definitions Document
19 February 2014 Presentation Presentation by Greg Steffens on Row-Level Metadata
19 February 2014 Meeting Minutes Meeting Minutes
12 February 2014 Working Document Metadata Definitions Document
12 February 2014 Meeting Minutes Meeting Minutes
29 January 2014 Working Document Metadata Definitions Document
29 January 2014 Meeting Minutes Meeting Minutes
15 January 2014 Working Document Metadata Definitions Document
15 January 2014 Meeting Minutes Meeting Minutes
08 January 2014 Working Document Metadata Definitions Document
08 January 2014 Meeting Minutes Meeting Minutes
18 December 2013 Working Document Metadata Definitions Document
18 December 2013 Meeting Minutes Meeting Minutes
04 December 2013 Working Document Metadata Definitions Document
04 December 2013 Meeting Minutes Meeting Minutes
20 November 2013 Working Document Metadata Definitions Document
20 November 2013 Meeting Minutes Meeting Minutes
13 November 2013 Working Document Metadata Definitions Document
13 November 2013 Meeting Minutes Meeting Minutes
30 October 2013 Working Document Metadata Definitions Document
30 October 2013 Meeting Minutes
23 October 2013 Working Document Metadata Definitions Document
23 October 2013 Meeting Minutes
25 September 2013 Working Document Metadata Definitions Document
25 September 2013 Meeting Minutes
11 September 2013 Working Document Metadata Definitions Document
11 September 2013 Meeting Minutes Meeting Minutes
11 September 2013 Presentation Controlled Terminology: its use in (Static) Information Models and in Applications
21 August 2013 Working Document Metadata Definitions Document
14 August 2013 Working Document Metadata Definitions Document
14 August 2013 Meeting Minutes
07 August 2013 Working Document Metadata Definitions Document
07 August 2013 Meeting Minutes
17 July 2013 Working Document Metadata Definitions Document
17 July 2013 Meeting Minutes
03 July 2013 Working Document Metadata Definitions Document
03 July 2013 Meeting Minutes Meeting Minutes
19 June 2013 Working Document Metadata Definitions Document
19 June 2013 Meeting Minutes Meeting Minutes
05 June 2013 Working Document Metadata Definitions Document
05 June 2013 Meeting Minutes Meeting Minutes
17 May 2013 Working Document Metadata Definitions Document
17 May 2013 Meeting Minutes Meeting Minutes