OASIS DITA Pharma · DITA Pharma SC Welcome The OASIS DITA Pharmaceutical Content Subcommittee (DITA Pharma SC) will define DITA topics, maps, associated metadata properties and terminology

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




Content Plan

Module 3 Quality

Module 2 Summaries




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




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