"The Roadmap for Nonclinical Data Standards and Elements to Improve Data Access"

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The Roadmap for Nonclinical Data Standards and Elements to Improve Data Access


To navigate through the content of this ePaper, please click on hyperlinked sections in the Table of Contents below.
To download the ePaper as a pdf document, please navigate to the Nonclinical Roadmap team's website where you can find it under 'Accomplishments'.

Table of Contents

1. Introduction (below)

Information on data standards implementation
2. Considerations for Implementing Standards
3. Setting the right foundation for communication
Considerations for data standardization
4. Future Standardization
5. Prioritization of Nonclinical Data

  • Figure 1. Priorities for Nonclinical Study Groups.
  • Figure 2A. Priorities for Nonclinical Study Types
  • Figure 2B. Priorities for Miscellaneous Studies
  • Figure 3. Priorities for Data Elements.

6. Summary

7. Links for Stakeholders



Introduction

Advances in informatics and data standards are helping to optimize nonclinical data utility to meet demands for more effective and efficient drug development. The CDISC Standard for Exchange of Nonclinical Data (SEND) team is currently working to standardize nonclinical study types. The FDA, as well, is establishing regulatory guidance for the electronic submission of these nonclinical studies. Collectively, these efforts make this a formative time for stakeholders of these standards.

As a result, the FDA’s Center for Drug Evaluation and Research (CDER) in conjunction with representatives across the industry have formed a collaboration aimed at addressing common issues with regards to nonclinical data management, data standards, and standards implementation. A Nonclinical Working Group within the collaboration identified several areas of interest and formed teams to work on each one. A summary of the Nonclinical Working Group and its various work-group teams is provided in the resource list at the end of this document. More information may be found in the following link: Non-Clinical Road-map and Impacts on Implementation Wiki.

One of the working groups, the Nonclinical Standards Roadmap Team (Roadmap Team), identified a need to orient newcomers to standards, set priorities for nonclinical data, and consider ways to facilitate future standardization efforts. Similar to what has already been done for clinical data by CDISC, the group realized a need to develop a strategy on how to prioritize, maximize, and revamp the standardization efforts for nonclinical data. The team aimed to create a nonclinical standards roadmap which could be useful to all, whether one is a novice or working on future steps in nonclinical data standardization.

The Roadmap Team focused on the following objectives:
• Identify points to consider for implementing a standard with a goal to minimize redundancy and maximize collaboration
• Highlight important steps of the data standardization process
• Prioritize the nonclinical data types
• Design a survey and obtain results from members of industry to further understand the priorities of the many stakeholders of nonclinical data
• Compile list of key standards resources (Click for Links for Stakeholders) for implementing the best approach for future standardization efforts
• Inform stakeholders about the types of standards and standards organizations that are available and the potential role that stakeholders can play in standards development

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