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 facilitate future research while preserving the privacy of patients, investigators and clinical trial staff.
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.
- Protection of Personal Data in Clinical Documents – A Model Approach
- De-identification and Anonymization of Individual Patient Data in Clinical Studies – A Model Approach (V2.0)
- Layperson Summaries of Clinical Trials: An Implementation Guide
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 a more consistent voice from the 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
For more information about our model approaches and guidance, please see our Initiative Assets below.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
Common Protocol Template
The Common Protocol Template Initiative is working with industry stakeholders and regulators to create a model clinical trial protocol template containing a common structure and model language to improve accuracy in data recordation and speed study start up.
Risk Based Monitoring
TransCelerate’s Risk Based Monitoring Initiative seeks to develop a model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.