Metadata can be used for humans or computers. Humans use descriptive metadata while computers use structured metadata. There are different types of metadata including descriptive, structural, and process metadata. Electronic document management systems can provide different views or "metaviews" of data based on the metadata used. Standardizing metadata is important to avoid issues when different systems use inconsistent metadata, which can waste resources.

1. Views of Metadata and
MetaViews of Data:
The Power of EDMS Systems
Donald Palmer
Associate Director, Regulatory Systems
February 2009

2. “Two thirds of Americans can't do fractions. The other half,
just don't care.” - Unknown
The Road We Take – Simple?

3. Agenda
’Data about Data’ So what?
–Metadata for Humans
–Metadata for Computers
Metadata Types – Views of Metadata
–Metadata Types and eCTD
MetaViews of Data
–Changing Views of Documents: eCTD & Authors
–EDM Metadata Issues
Summary

4. Content of a document is for Human use
–Computers don’t understand content
Human data about content is specific to the
content
Computer data is about an object, not really
about the content
Human Data vs Computer Data
‘Data about Data’ So What?

5. Content presumes an environment in which to
understand that document
–Topic/Subject, Expertise, Audience
Metadata about content can be free-form
–Description, Summary
Metadata for Humans
‘Data about Data’ So What?

6. BioPharmaceutical Pre-Market Process
(Environment)
Metadata for Humans
STDY-0123
Author: Barack Doe
Title: Study Report
Date: 03-Jan-2005
Structured Metadata
Synopsis: Safety Animal Study concluding no problems.
Description: Animal Study using Mice and WonderDrug.
Side Effects: Mice got ticklish.
Study: Study # CS-V4321 – 10 mg/mL in Mice for 15 days
Document Title: Study Report on Jan. 3, 05 by Barack Doe
Free-Form or Unstructured Metadata
‘Data about Data’ So What?

7. Computers deal with Structured metadata
Computer metadata is used to categorize
documents
Documents can be placed into a structure based
upon computer metadata
Metadata for Computers
‘Data about Data’ So What?

8. Metadata for Computers
Document
Author: Barack Doe
Title: Study Report
Date: 03-Jan-2005
Structured Metadata
Object ID: 3e4dols9j52m0dpm4qm7x93
Creation Date: 3443472000 (seconds after year 1900)
Format: MS Word 2003 (.doc)
Computer Metadata - Structured
Electronic Document Management (EDM) System
‘Data about Data’ So What?

9. Descriptive
–Identifies a characteristic about the content
Structural
–Places the content into a larger organization of
information
Process
–Specifies a stage in a transformation
Metadata Types

10. STDY-0123
Author: Barack Doe
Title: Study Report
Date: 03-Jan-2005
Structured Metadata
Synopsis: Safety Animal Study concluding no problems.
Description: Animal Study using Mice and WonderDrug
Side Effects: Mice got ticklish
Free-Form or Unstructured Metadata
Object ID: 3e4dols9j52m0dpm4qm7x93
Creation Date: 3443472000 (seconds after year 1900)
Format: MS Word 2003 (.doc)
Computer Metadata - Structured
Metadata Types - Descriptive

11. STDY-0123
Doc-Type: NonClinical
Doc-Sub-Type: Safety Study
Doc-Category: Mice Study
Structural Metadata
NonClinical
Safety
Study
Mice
Study
Metadata Types - Structural

12. STDY-0123
Version: 2.0
Status: Approved
Retention Date: 31-DEC-2020
Process Metadata
Draft
Review
Approved
Effective
Metadata Types - Process

13. STDY-0123
Doc-Type: NonClinical
Doc-Sub-Type: Safety Study
Doc-Category: Mice Study
Structural Metadata
NonClinical
Safety
Study
Mice
Study
Draft
Review
Approved
Effective Version: 2.0
Status: Approved
Retention Date: 31-DEC-2020
Process Metadata
Author: Barack Doe
Title: Study Report
Date: 03-Jan-2005
Structured Metadata
Synopsis: Safety Animal Study concluding no problems.
Description: Animal Study using Mice and WonderDrug
Side Effects: Mice got ticklish
Free-Form or Unstructured Metadata
Object ID: 3e4dols9j52m0dpm4qm7x93
Creation Date: 3443472000 (seconds after year 1900)
Format: MS Word 2003 (.doc)
Computer Metadata - Structured
Metadata Types – All Together

14. Descriptive
– Module 1 Information: Sponsor Name, Application
Date, Application Type
Structural:
– Application Nbr., Sequence Nbr., Module, CTD Heading
Process:
– Version Nbr., Status, Approved Date
Metadata Types – For eCTD

15. WonderDrug
Labeling
Application Nbr: 998877
Sequence Nbr: 0010
Module: Admininstrative
CTD Heading: Labeling
Structural Metadata
Draft
Approved
Effective
Version: 2.0
Status: Approved
Approved Date: 12-FEB-2009
Process Metadata
M1.14
Labeling
M1.14.1
Draft Label
Module 5
Efficacy
Module 4
Safety
Module 3
Quality
Module 2
Summary
Module 1
Admin
M1.14.2
Final Label
Seq. Nbr
0010
Application Nbr
998877
Sponsor: MedImmune
Application Date: 23-MAR-2009
Application Type: IND
Descriptive Metadata
Metadata Types – For eCTD

16. Different Groups want to see documents differently
– Submission Publishers
– Document Authors
– Clinical Trial Management
– Manufacturing
EDM Systems can allow for different Views
– Views are based upon Metadata – ‘MetaViews’
MetaViews of Data

17. WonderDrug
Clinical Study
Sequence Nbr: 0010
Module: Efficacy (5)
CTD Maj-Heading: M5.3 – Clinical Study Reports
CTD Min-Heading: M5.3.5 Clinical Reports of Efficacy
CTD Heading: M5.3.5.1 – Controlled Clinical Studies
Structural Metadata – EDM & Publishing
M5.3.5
Reports of
Efficacy M5.3.5.1
Controlled
Clinical Studies
Module 5
Efficacy
Module 4
Safety
Module 3
Quality
Module 2
Summary
Module 1
Admin
Seq. Nbr
0010
M5.3
Clinical Study
Reports
New
Operation: New
Version: 1.0
Process MetadataIndication: Influenza Virus
Descriptive Metadata – M5.3.5
MetaViews of Data – for eCTD

18. WonderDrug
Cover Letter
Indication: Influenza Virus
Descriptive Metadata
IND
Cover Letter
Regulatory
Quality
NonClinical
Administrative
Status: UnSigned
Version: 1.0
Process Metadata
WonderDrug
Clinical Study
Clinical
Product
Vaccine
Study Nbr
CS-1234
Clinical Study
Body
Indication:
Influenza Virus
Product: Vaccine Application Type: IND
Doc-Type: Regulatory Doc-Category: Cover Letter
Doc-sub-Type: Administrative
Structural Metadata
Product: Vaccine Study Nbr: CS-1234
Doc-Type: Clinical Doc-Category: Clinical Study Body
Indication: Influenza Virus
Structural Metadata
Signer: Dr. Reggy Affairs
Descriptive Metadata
Status: Signed
Version: 2.0
Process Metadata
MetaViews of Data – for Authors

19. Different EDM Systems use different Metadata -
causing issues
– External Authors
– Partners
– Mergers & Acquisitions
Consider 10,000’s Documents in EDM
MetaViews of Data – Issues

20. Indication: Influenza Virus
Descriptive MetadataWonderDrug
Clinical Study
Clinical
Product
Vaccine
Study Nbr
CS-V1234
Clinical Study
Body
Indication:
Influenza Virus
Therapeutic Area: Vaccines
Product: PRD-5432
Doc-Type: Efficacy
Study Nbr: CS-V1234
Structural Metadata
Indication: Influenza Virus
Descriptive Metadata
Product: Vaccine Study Nbr: CS-1234
Doc-Type: Clinical Doc-Category: Clinical Study Body
Indication: Influenza Virus
Structural Metadata
Therapeutic
Area:
Vaccines
Product
PRD-5432
Efficacy
Study Nbr
CS-V1234
WonderDrug
Clinical Study
MetaViews of Data – Partnerships

21. EDM Systems need Standard Views
EDM Systems need Metadata
EDM Reference Model
– DIA EDM SIAC Reference Model Sub-Group
MetaViews of Data – Solution

22. Indication: Influenza Virus
Descriptive Metadata
WonderDrug
Clinical Study
Therapeutic Area: Vaccines
Product: PRD-5432
Functional Area: Clinical
Indication: Influenza Virus
Study Nbr: CS-V1234
Doc-Type: Clinical Study Body
Structural Metadata
Indication: Influenza Virus
Descriptive Metadata
Clinical
Study Nbr
CS-V1234
Clinical Study
Body
Indication:
Influenza Virus
Therapeutic
Area: Vaccines
Product
PRD-5432
Product
PRD-5432
Study Nbr
CS-V1234
Clinical
Indication:
Influenza Virus
Therapeutic
Area: Vaccines
Clinical Study
Body
MetaViews of Data – Partnerships

23. Summary
Human Metadata vs Computer Metadata
Metadata Types: Descriptive, Structural, Process
Views can vary based upon Metadata
Incommensurate Metadata can consume Money