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Clinical Data Transparency

Rationale

As regulators and other stakeholders push the industry towards increased transparency, there is a need for a viable approach to increase transparency while protecting the privacy of individuals involved in clinical trials. TransCelerate’s Clinical Data Transparency (CDT) Initiative was formed with a mission enabling ready compliance with regulations designed to enhance transparency and facilitating future research while preserving the privacy of patients, investigators and clinical trial staff.

Impact

The CDT Initiative has published the following assets that provide guidance and model approaches for redacting privacy information found in clinical study reports, anonymizing patient level data shared with the broader healthcare community, and preparing and distributing layperson summaries to the general public and study participants.

  1. Protection of Personal Data in Clinical Documents – A Model Approach
  2. De-identification and Anonymization of Individual Patient Data in Clinical Studies – A Model Approach (V2.0)
  3. Layperson Summaries of Clinical Trials: An Implementation Guide

Benefits

Benefits for Sponsors

  • Enables efficient and effective compliance with changes in a dynamic regulatory landscape
  • Provides an industry voice of regulatory interactions
  • Improves efficiency in the redaction / anonymization process
  • Provides considerations / tools to give patients access to study summary results

Benefits for Researchers

  • Creates model process and mechanism for collecting and redacting patient information

Benefits for Regulators

  • Receive more consistent voice from industry
  • Provide reassurance that patient data and regulatory concerns are being protected

Benefits for Study Participants

  • Provide greater comfort about data protection and privacy concerns

Available Assets

For more information about our model approaches and guidance, please see our Initiative Assets below.

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