Welcome to the Clinical Content & Reuse Initiative Asset Page
The Clinical Content & Reuse (CC&R) Initiative aims to enhance clinical trial processes by developing common content for reuse across clinical trial documents. The initiative is working towards having electronic, machine-readable documents and improving overall end-to-end efficiencies.
|Guiding Principles for Clinical Content & Reuse|
|About Clinical Content & Reuse|
Basic word and electronic templates for the common protocol (CPT), statistical analysis plan (SAP), and clinical study report (CSR) are available below along with resources to support their use, implementation, and adoption. The templates can be used individually or together to achieve content reuse.
CSR Considerations for Studies Disrupted by the COVID-19 Pandemic
TransCelerate announces a new asset, CSR Considerations for Studies Disrupted by the COVID-19 Pandemic (Updated with Sample Text), now available for download. This document was created by clinical scientists, pharmacovigilance experts, data scientists, and other experts to identify the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports due to disruptions caused by COVID-19. At this time, no further updates to this content are planned, though TransCelerate will be seeking further input from experts and regulators to guide CSRs for studies disrupted by COVID-19.
2019 Release Highlights
TransCelerate is excited to announce that the Common Protocol Template (CPT) is now a foundational component of the newly formed Clinical Content & Reuse Initiative. Since November 2018, we have collected feedback to further improve the utility and sustainability of the CPT, SAP, and CSR. We are now releasing our first version of the eTemplates along with updated versions of the previously available word editions!
The assets below have been created to support the use, implementation, and adoption of the Clinical Template Suite (CTS) and eTemplates. Under each tab, you will find template-specific release updates, guidance documents, and the templates needed to get your organization started!