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Welcome to the Clinical Content & Reuse Initiative Solutions Page
The Clinical Content & Reuse (CC&R) Initiative aims to enhance clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents that can be reused throughout the project lifecycle to enable digitization and traceability through automation.
What’s New
CC&R Initiative & Solutions
With the 2024 Release, the Clinical Template Suite (CTS) continues to reflect state of the art research trends and guidance while successfully reaching its value and impact goals. Those being:
- developing harmonized protocol structure and proposed model content
- demonstrating value in automation and reuse of selected protocol content
- helping to lay a foundation for digitization of the protocol and study design elements
While future plans for CTS template content revisions are evolving, their place in the clinical trial ecosystem is undeniable and download and use by stakeholders continues. We anticipate valuable innovations coming from ICH M11, Digital Data Flow, and the HL7 Vulcan: Utilizing Digital Protocols Project impacting the protocol space and will evaluate future alignment opportunities. As always, use of these assets is completely voluntary and customization/update is left to the discretion of each sponsor.
CTS eTemplates: At this time, no further development or updates to the eTemplates functionality are planned. Because of this, TransCelerate is making the source code for the eTemplate suite available to the public pursuant to an open source license agreement. After clicking to accept the license, individuals can download the code base and supporting materials to aid in their implementation of the CTS eTemplates. Navigate to the eTemplates Tab further down on this page to download the eTemplates Source Code file.
For information relating to ongoing protocol digitization efforts see TransCelerate’s Digital Data Flow initiative here.
2024 Release Summary
The 10th CTS Release & Implementation Toolkit (January 2024) reflects evolved best practices (i.e., master protocols, pregnancy & breastfeeding, reducing gender-specific language, liver safety) as well as other content topics (PRO’s, EU-CTR alignment, Statistical Analyses approach, CTIS) and supports other TransCelerate initiatives by incorporating the MCTC Data Return Plan & PE Study Participation Feedback Questionnaire into the CPT. Additionally, the eTemplates have been updated to address a series of systemic functionality “bugs” that have been identified over the past several releases.
New assets include:
- A CTS integrated participant type library for trials enrolling pregnant participants (See CPT Libraries tab)
- A basic Word library outlining liver safety considerations for oncology trials (See CPT Libraries tab)
- Summary findings from SoA redesign exploration efforts (See Innovation & Collaboration)
- A guidance for design considerations for master protocols (See Innovation & Collaboration)
Along with updated CTS assets and Implementation Toolkit resources.
What is Clinical Content & Reuse
About Clinical Content & Reuse
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Innovation & Collaboration
The Clinical Content & Reuse initiative, in addition to maintaining the CTS, has been involved with numerous innovative exploratory activities & collaborations aimed at enhancing the clinical research ecosystem. Click on the tabs below to learn more & see related tools and resources.
Following a three-year initiative, the IMI sponsored EU-PEARL team released 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:
Building upon this collaboration, the CC&R team incorporated key recommendations related to master protocol design into the 2024 CPT, and also created a guidance document for design considerations for complex studies.
In the Fall of 2020, TransCelerate’s Clinical Content & Reuse Initiative released:
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 took their lessons learned and in 2022 published proposals to address these challenges in:
Over the past two years, the CC&R team has been exploring avenues towards improving Schedule of Activities design with an eye towards digitization.
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:
In 2022-3, the team explored the possibility of SoA redesign with various stakeholders in mind. A perspective on the future state of the Schedule of Activities and its potential, focusing on redesign toward a “Stakeholder View Approach” to address multiple end user needs, can be found here: