Standardization Roadmap

Project Scope 

Need/Challenge

Need ID 0030. Currently, the SEND standard allows for the submission of general tox and carc studies in electronic standardized format. However, there are additional study types that are generally received that have not been standardized. There is a need to develop a strategy on how to plan, maximize, and transform standardization efforts. This plan should take into account resources, complexity, timeline and new approaches and technologies. Data gaps have been identified for many assessments, including Safety Pharm, Repro, Genetox, hERG, Animal Rule/MCM, Receptor Screen, and Device combination. Additionally, drug metadata can be better utilized so that, for example, Lot and Impurity information can be linked to study data, class, structure. Study Metadata represents another challenge. Information on protocol-related info + deviations, regulatory interpretation, sponsor interpretation, and regulatory information can be structured and linked so that information for a single study or across studies is more accessible.

Vision

Availability of useful electronic meta- and study data to enable more effective and efficient review of nonclinical data by both industry and regulatory reviewers. Data should be accessible to further investigate class effects and address regulatory science questions.

A vast number of stakeholders will be impacted by the transformation and implementation of data standards. As the impact will be broad, we need representation from people with diverse backgrounds to join and actively participate in this group. A broad representation from the pharmaceutical industry, contract research organisations, software vendors and other stakeholders in data standardisation and eventually regulatory submissions will ensure the most complete and robust picture for the industry and the regulators to align to going forward.

• Participants may have backgrounds which include (but are not limited to)
  • Pharmacologists/Toxicologists
  • Pathologists
  • Pharmacokineticists
  • Informatics and database specialists
  • Those with experience in data standardization
  • Those implementing data standards

Member Commitment

• Teleconferences will require active participation for approximately 1 hour every two weeks. Our open forum needs your creative and innovative ideas.
• Projects will require time and effort outside of general teleconferences. Time commitments will vary but are likely to take several hours per month.
• Ongoing email/phone correspondences and additions to the Wiki are essential to developing these projects.
• Members contribute to Wiki content, meeting proceedings, and presentations that result from the group's effort.