With increased transparency, there is a need for a common approach to protect the privacy of individuals involved in clinical trials. With this in mind, the Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.
This Initiative will enhance transparency and facilitate future research while preserving the privacy of patients, investigators and clinical trial staff. The model approach may also enable regulatory compliance, improve collective scientific knowledge and clinical practice and care for patients and bring consistency and quality by working across all stakeholder groups.
For more information about our model approach 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 an model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.