As of June 2019, the TransCelerate CDT initiative has successfully completed all initiative objectives, with two assets transitioned to PhUSE and the remaining asset to be maintained by TransCelerate’s Clinical Research Access & Information Exchange. No new deliverables are planned.
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 authored 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.
The revised papers Protection of Personal Data in Clinical Documents – A Model Approach and De-identification and Anonymization of Individual Patient Data in Clinical Studies – A Model Approach can now be found on PhUSE’s website. PhUSE will continue to update the papers as needed. PhUSE was well-positioned to own these bodies of work as it can leverage a broader set of stakeholders around the globe to facilitate increased holistic thinking around these assets so these papers can live on in the R&D ecosystem.
The layperson summaries can be found on TranCelerate’s Clinical Research Access & Information Exchange solutions page.
Clinical Research Access & Information Exchange
Clinical Research Access & Information Exchange seeks to provide a better window into information about clinical research and trial options and to contribute to a more rewarding clinical trial experience via better exchange of information with trial participants.
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.