Metadata Views (by Donald Palmer)

Views of Metadata and MetaViews of Data:

The Power of EDMS Systems

Donald PalmerAssociate Director, Regulatory Systems

February 2009

“Two thirds of Americans can't do fractions. The other half, just don't care.” - Unknown

The Road We Take – Simple?

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

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?

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


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


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


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


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

STDY-0123

Author: Barack Doe

Title: Study Report

Date: 03-Jan-2005

Structured Metadata


Description: Animal Study using Mice and WonderDrug

Side Effects: Mice got ticklish






Metadata Types - Descriptive

STDY-0123

Doc-Type: NonClinical

Doc-Sub-Type: Safety Study

Doc-Category: Mice Study

Structural Metadata

NonClinical

SafetyStudy

MiceStudy

Metadata Types - Structural

STDY-0123

Version: 2.0

Status: Approved

Retention Date: 31-DEC-2020

Process Metadata

Draft

Review

Approved

Effective

Metadata Types - Process

STDY-0123

Doc-Type: NonClinical

Doc-Sub-Type: Safety Study

Doc-Category: Mice Study

Structural Metadata

NonClinical

SafetyStudy

MiceStudy

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


Description: Animal Study using Mice and WonderDrug

Side Effects: Mice got ticklish






Metadata Types – All Together

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

WonderDrugLabeling

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

M1.14Labeling

M1.14.1Draft Label

Module 5Efficacy

Module 4Safety

Module 3Quality

Module 2Summary

Module 1Admin

M1.14.2Final Label

Seq. Nbr0010

Application Nbr998877

Sponsor: MedImmune

Application Date: 23-MAR-2009

Application Type: IND

Descriptive Metadata

Metadata Types – For eCTD

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

WonderDrugClinical 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

M5.3.5Reports of

Efficacy M5.3.5.1Controlled

Clinical Studies

Module 5Efficacy

Module 4Safety

Module 3Quality

Module 2Summary

Module 1Admin

Seq. Nbr0010

M5.3Clinical Study

Reports

New

Operation: New

Version: 1.0

Process MetadataIndication: Influenza Virus

Descriptive Metadata – M5.3.5

MetaViews of Data – for eCTD

WonderDrugCover Letter

Indication: Influenza Virus


IND

Cover Letter

Regulatory

Quality

NonClinical

Administrative

Status: UnSigned

Version: 1.0

Process Metadata


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


Structural Metadata

Signer: Dr. Reggy Affairs


Status: Signed

Version: 2.0

Process Metadata

MetaViews of Data – for Authors

Different EDM Systems use different Metadata - causing issues– External Authors

– Partners

– Mergers & Acquisitions

Consider 10,000’s Documents in EDM

MetaViews of Data – Issues


Descriptive MetadataWonderDrugClinical Study

Clinical

Product Vaccine

Study Nbr CS-V1234

Clinical Study Body


Therapeutic Area: VaccinesProduct: PRD-5432Doc-Type: Efficacy

Study Nbr: CS-V1234

Structural Metadata



Product: Vaccine Study Nbr: CS-1234

Doc-Type: Clinical Doc-Category: Clinical Study Body


Structural Metadata

Therapeutic Area:

Vaccines

Product PRD-5432

Efficacy

Study Nbr CS-V1234


MetaViews of Data – Partnerships

EDM Systems need Standard Views

EDM Systems need Metadata

EDM Reference Model– DIA EDM SIAC Reference Model Sub-Group

MetaViews of Data – Solution




Therapeutic Area: VaccinesProduct: PRD-5432Functional Area: ClinicalIndication: Influenza VirusStudy Nbr: CS-V1234Doc-Type: Clinical Study Body

Structural Metadata



Clinical

Study Nbr CS-V1234

Clinical Study Body


Therapeutic Area: Vaccines

Product PRD-5432

Product PRD-5432

Study Nbr CS-V1234

Clinical


Therapeutic Area: Vaccines

Clinical Study Body

MetaViews of Data – Partnerships

Summary

Human Metadata vs Computer Metadata

Metadata Types: Descriptive, Structural, Process

Views can vary based upon Metadata

Incommensurate Metadata can consume Money

Metadata Views (by Donald Palmer)

Healthcare

Transcript of Metadata Views (by Donald Palmer)