DITA Pharma SCDITA Pharma SC
OASIS DITA Pharma
Initial Meeting – 30 July 2009
DITA Pharma SC
Agenda – DITA PCSC
• Welcome
• Objectives of today’s meeting
• Introductions – Round Robin
• Expectations of the Group – Round Robin
• Story Boards of Opportunity – DITA in Pharma
DITA Pharma SC
Welcome
The OASIS DITA Pharmaceutical Content Subcommittee (DITA Pharma SC) will define DITA topics, maps, associated metadata properties and terminology to streamline design and creation of the complete body of pharmaceutical documentation required to represent a product for scientific and regulatory purposes throughout its lifecycle.
Initial objectives are to define topics and maps as required to implement:
– ICH CTD (Common Technical Document) content specification
– US IND (Investigational New Drug) content specification
– EU CTA (Clinical Trial Authorization) content specification
– FDA Structured Product Labeling content specification
– EU Product Information Management content specifications.
To optimize the value of DITA it is an objective to consider additional topics and maps for facilitating the internal business processes of content design, authoring, document review, submission assembly and regulatory portfolio management.
Page 3
DITA Pharma SC
E-Learning
Paper
Vision: A Common Base Format
Common Base FormatCommon Base Metadata Architecture
Working tier
Repository/
database tier
Publishing/
presentation tierSPL
HTML
PDFOpenXml
OpenXml
eCTD
IND
CTA
ODF
PIM
NN2
NN1
Word
FrameFrameMaker
Excel
Custom Custom Apps
XMetaL
Browser
Quark
Arbortext
InDesign
NN1
NN2
DITA Pharma SC
Requirements for a Common Base Format
Non-proprietary, open standard
Cross -media/-platforms/-products/-vendors/-companies/-time
Tools support and availability
Handle existing special pharma standards
Adapt to future special pharma standards
Handle special company requirements
Modular to support re-use
Advanced metadata capabilities
Field proven
Industry acceptance
DITA Pharma SC
Why DITA as the Common Base Format?
Open standard
Cross -media/-platforms/-products/-vendors/
-companies/-time
Tools support and availability
Handle existing and future special pharma standards
as well as special company requirements
Topic-oriented to support re-use
Advanced metadata capabilities
Field proven
Industry acceptance
YOU can influence this!
DITA Pharma SC
DITA: Handling Special Requirements
• “D” as in “Darwin”: Evolution and inheritance:
– Specialize and Generalize
• Built-in flexibility:<data>, <foreign>, and <unknown> elements
• Extensible: Specializations:
– Domain vocabularies
– Domain metadata architectures
– Domain topic types:
Domain vocabulariesDomain metadata
architecture
DITA Pharma SC
Administrative
Website
Summaries
Quality
Nonclinical Study Reports
Clinical Study Reports
PDFWord
PDFWord
WebsitePDFWordWebsitePDFWord
...
PDFWord
Website
Website
Reusable Topics
Clinical Protocols and Reports
Indications (Target Labeling)
Phase 3 Clinical Study Report
Special Populations
Composing Publications
Study Design: Method of Assigning Patients
Study Design: Evaluation Criteria-Efficacy
Statistical Methods
Synopsis
Study Design: Evaluation Criteria-Safety
Investigational Plan
Study Design: Dosage Special Populations
Single Source Publishing“Darwin Information
Typing Architecture”
DITA
Treatments
DITA Map
DITA provides a content supply
chain for Regulatory documents
DITA Pharma SC
Project Stewardship
“On Demand” Review
& Approval
“Darwin Information
Typing Architecture”
DITA
Phase 3 Clinical Study Report
Study Objectives
Composing Publications
Introduction
Investigational Plan
Study Patients
Efficacy Evaluation
Approved Topics
Safety Evaluation
Reusable Topics
*.dita
Clinical Protocols and Report Topics
Indications (Target Labeling)
Study Design: Method of Assigning Patients
Study Design: Evaluation Criteria-Efficacy
Study Design: Evaluation Criteria-Safety
Study Design: Dosage Special Populations
Reusable Topics
New Topics for Clinical Study Report
Protocol Deviations (summary)
Disposition of Patients (summary)
Efficacy Results – Primary (full)
Safety Results – Exposure Table (full)
Safety Results – Serious AE Table (full)
New Topics
Departmental Stewardship
“Pre-“ Review& Approval
Medical Writing - External
New Documents
Medical Writing - Internal
Content “Design to Re-use”
or “Re-purpose”
Take A Supply Chain Approach To
Authoring Tasks
Document & Topic Based Authoring
Complement Each Other
DITA Map
“in pharma today, topic and document based content must co-exist”
With DITA, submission management begins with the content supply chain…
DITA Pharma SC
Submission Strategy
Tier 2 Markets
Protocol and Study Report Topics
Standard Topic Library for Protocols
Target Studies
Study Design
Indication
Dosage and Administration
Use in Specific Populations
Number/Location of Study Centers
Study Phase
Objectives (Primary, Secondary)
Criteria for Evaluation: Efficacy
Criteria for Evaluation: Safety
Determines the Set of Topics Needed
Clinical Project Planning & Management
Marketing
Research& Development
Tier 1 Markets
Indications
PrimarySecondary
Dosage & Administration
PrimarySecondary
Clinical Strategy Standard Topic
Library for Reports
Standard Topic Library for Product
Dose Form & Strength
Indication
Treatment
Clinical Studies Determined by Development
Strategy
Clinical Dossier Driven by
Development Plan
Development Operating Committee
Content Architect
Published Documentation
Documents Published from
DITA Maps
Content Architect
Study Design – Clinical Phase 3
Protocol Synopsis
Standard DITA Maps
*.ditamap
Protocol Outline
Protocol Amendment
Protocol
Study Report – Clinical Phase 3
Study Report (Abbreviated)
Standard DITA Maps
*.ditamap
Study Report (Interim)
Study Report (Synopsis)
Study Report (Full)
Study Report (Data Listings)
Published Protocol
Published Study Report
planning and content design of the clinical content supply chain begins when a drug candidate is being considered for continuation into clinical development and continues
throughout the product’s lifecycle
DITA Pharma SC
Non-eCTD Electronic Submission – Market X
Module 3 Quality
Module 2 Summaries
Module 1 Administrative
Module 5 Clinical Study Reports
Module 4 Nonclinical Study Reports
Common Technical Document – Market Y
Module 3 Quality
Module 2 Summaries
Module 1 Administrative
Module 5 Clinical Study Reports
Module 4 Nonclinical Study Reports
Content Plan
Module 3 Quality
Module 2 Summaries
Module 1 Administrative
Module 4 Nonclinical Study Reports
Module 5 Clinical Study Reports
Target Labeling
Target Product Profile
Indications and Usage
Use in Specific Populations
Dosage Form & Strength
Pharmacology Studies
Toxicology Studies
Clinical Studies
Available Submission Documents
Submission Content
Is Driven By Regulatory
Strategy
eCTD DTD Transformation
Submission Planning & Management
Marketing
Research& Development
Tier 1 Markets
Tier 2 Markets
Rest of World
Submission Strategy
Submission Strategy
Regulatory Submissions to Markets
Module 3 Quality
Module 2 Summaries
Module 1 Administrative
Module 5 Clinical Study Reports
Module 4 Nonclinical Study Reports
DITA Maps Track & Implement The
Submission Content Plan
planning and content design for topic-based content continues through each regulatory submission and is integrated with that of the functional areas and content design