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Tools & Downloads
DIA Communities have developed a number of tools, information, case studies and best practices to help you in your jobs, taking advantage of best practices in real-world settings, vetted by an inter-disciplinary group of subject matter experts.

Regulatory Information Management (RIM) Whitepaper V2.0

Bayesian Case Studies

Electronic Document Management Reference Model

Framework for the Destruction of Paper

GMP Quality Systems Reference Model

Trial Master File Reference Model v3.3.1

Visual Model of Patient Engagement in Benefit-Risk Assessment through the Medical Product Life Cycle

Regulatory Information Management (RIM) Whitepaper V2.0

This Whitepaper is part of a broader initiative of the Regulatory Information Management (RIM) Working Group within DIA’s Regulatory Affairs Community. The Working Group has identified significant potential value from development of a RIM Reference Model, a conceptual framework for RIM systems and processes. The Reference Model is intended to aid organizations in structuring the complex organizational, data, process, information, and workflow issues as they implement or upgrade their RIM systems.

The Whitepaper is an expansion of an earlier RIM consensus paper. Version 2.0 covers a broad range of regulatory capabilities, including but not limited to regulatory intelligence, planning and tracking, labelling, correspondence and commitment management, change control, regulatory analytics and use of AI and machine learning technologies. The paper includes definitions, trends and best practices reflecting the experience of the authors and editorial team who represent well over 100 years of industry experience.

Download White Paper

IA Definitions

DIA RIM Reference Model V1

Bayesian Case Studies
The Bayesian case example repository, supported by the DIA Bayesian Scientific Working Group, contains a series of case studies demonstrating examples of the use and value of Bayesian statistics in medical product development.

Electronic Document Management Reference Model

DIA Community for Document and Records Management developed an initiative aimed at developing a taxonomy/metadata reference model that can ultimately be shared by biopharmaceutical organizations as a common starting point for building sustainable, shareable EDM repositories.

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Download Guide

Framework for the Destruction of Paper 2.0

DIA Community for Document and Records Management has defined the critical requirements for destruction of paper records for better content management.

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GMP Quality Systems Reference Model

Represents the combined work of DIA volunteers in the Document and Records Management community and provides a model of accepted practices across the industry for the organization (taxonomy) and metadata properties of GMP Quality Systems documentation. Can be used by any biopharmaceutical company as a common starting point for building sustainable, shareable repositories for the management of GMP Quality Systems documentation.

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Trial Master File Reference Model v3.3.1

The TMF Reference Model defines standard contents, structure, terminology and metadata for the Trial Master File, essential documents which allow verification of the conduct of a clinical trial and the quality of the data generated.

Download Model

Review Materials

DIA: A Pioneer in Patient Engagement

In 2006, DIA was among the first organizations to recognize the importance of patient involvement in drug development and launched its first Patient Fellowship Program. Since then, the role patients can play in therapeutic product R&D has exploded. DIA continues to lead the way, providing input and insights into the evolution of therapeutic product development, and driving towards improved health and well-being throughout the world. DIA believes patients should be at the epicenter of the drug development life cycle, and for more than 15 years has pioneered efforts to advocate for the patient voice and discuss future patient engagement efforts across the health care continuum.

DIA-CTTI

DIA-EUPATI

DIA-PCORI

DIA-Tufts

Visual Model of Patient Engagement in Benefit-Risk Assessment through the Medical Product Life Cycle

Engaging patient stakeholders in benefit-risk decision making throughout the medical product life cycle is key to meeting patient needs. This visual model, created by participants of a 2015 DIA conference on this topic and partially funded by an Engagement Award from the Patient-Centered Outcomes Research Institute (PCORI), depicts how we are engaging patients in benefit-risk decision making and where stakeholder efforts can improve patient outcomes.

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Model Webinar

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