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 (e.g. CPT, SAP, and CSR). The initiative is working towards having electronic, machine-readable documents and improving overall end-to-end efficiencies.
We Need Your Input
Master Protocol Design & Implementation Survey
Master Protocols provide the design of clinical trials intended to simultaneously evaluate more than one intervention and/or more than one disease type within the same overall trial structure in adult and pediatric disease/conditions (FDA Guidance March 2022: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics).
The TransCelerate Clinical Content & Reuse (CC&R) team launched the first edition of the Common Protocol Template (CPT) in 2016 for use in all phases of interventional clinical trials (though not expressly designed with master protocols in mind). The CC&R team would like to understand what makes a successful master protocol, including insight into challenges related to master protocol design and, for CPT users, if and how the CPT may be used to capture the more complex aspects of master protocols . To that end, we are requesting your input on a brief survey regarding Master Protocols (MPs). Please follow the link below.
As always, participation in TransCelerate surveys is voluntary. Responses will have all identifying information removed by the PMO/TransCelerate legal before sharing with the team.
The TransCelerate Clinical Content & Reuse team congratulates the members of the IMI-sponsored EU-PEARL team on the launch of the Master Protocol, Intervention Specific Appendix (ISA or subprotocol), and Statistical Analysis Plan included in the generic template suite for integrated research platform trials. This three-year initiative culminated in the release of master protocol, ISA, and statistical analysis plan templates based on TransCelerate’s Clinical Template Suite (CPT & SAP templates) as well as other supporting assets. You can find these tools by following this link to EU-PEARL’s Suite of Master Protocol Templates.
In the Fall of 2020, TransCelerate’s Clinical Content & Reuse Initiative released: “CSR Considerations for Studies Disrupted by the COVID-19 Pandemic.” Since that time, both ACRO and TransCelerate member companies have faced unprecedented interruptions to clinical trials caused by an increasingly diverse set of circumstances. ACRO and TransCelerate have taken the lessons learned from the past three years and published proposals to address these challenges in “Points to consider when developing a Clinical Study Report (CSR) for a clinical trial that has been disrupted due to unforeseen circumstances.”
In 2021, the CC&R Team conducted a proof of concept exercise & landscape analysis to determine the general feasibility of establishing a procedures library to support protocol design and digitization. The results of that exercise, aimed at supporting the evolution towards a digitized protocol have been summarized in a white paper, “Examining Possibilities for a Consistent Procedures Library to Modernize Clinical Trials: A TransCelerate Point of View.”
What is Clinical Content & Reuse
About Clinical Content & Reuse
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2022 Release Addendum
It was decided that CC&R would implement an extended release cycle over 2022-23. Work has progressed on several key content topics during this year which has resulted in the 2022 CTS Content Addendum, providing a “line of sight” to these content updates that will ultimately be considered for formal inclusion in the next CTS release. In conjunction with the Content Addendum, the team is providing Tracked Changes Files of the BWE Draft Templates for use by anyone wishing to reflect these changes in their own current templates prior to the next formal CTS release. Note: Any stakeholder wishing to use these proposed updates does so at their own risk as there is no guarantee that all content updates will ultimately be incorporated into the final version of the next release or that other changes will not be made to the final release given the potential for changes in the ecosystem or potential feedback that TransCelerate could receive from affected stakeholders.
In addition to the Content Addendum, we have dramatically repackaged the Implementation Toolkit with an eye towards maintenance and sustainability. Though the content from our legacy assets is still available to support you in implementing the CTS, many assets have been combined to make asset and website maintenance more efficient. A key new asset to support this effort is the Implementation Support Resource (ISR) which you will find referenced throughout the CC&R website.
2021 Release Highlights (Most Recent Release)
TransCelerate is excited to announce our 2021 release! In this year’s release, users will find Clinical Template Suite (CTS) content enhancements continuing in the areas of registry automation (ClinicalTrials.gov) & content quality, incorporation of pandemic-related learning, estimand clarifications, as well as user-driven feedback on template clarity. On the technical side, updates were made to the eTemplates technical framework, along with enhancements to the template wizard experience and other authoring interface improvements.
Please find assets below to support the use, implementation, and adoption of the templates. Under each tab, you will find template-specific release updates, guidance documents, and the templates needed to get your organization started!