Clinical Content & Reuse

Clinical Content & Reuse (CC&R) Initiative, formerly known as Common Protocol Template (CPT), enhanced clinical trial processes by developing common content for reuse across clinical trial documents in the Clinical Template Suite (CTS). As of November 2024, this initiative is complete. No new solutions or updates are planned. However, this work serves as a foundation for other work with Digital Data Flow and other related initiatives.

What is Clinical Content & Reuse (CC&R)

Click on the Harmonized Model Content, Reuse Capabilities and Clinical Template Suite sections to learn more about CC&R.

CCR Reuse Capabilities Harmonized Model Content Clinical Template Suite Guiding Principles CPT, SAP, CSR Clinical Content & Reuse Flexible Implementation Options eCPT, eSAP, eCSR GCP AND ICH ALIGNMENT STRATEGIC ENGAGEMENT TRACEABILITY REGISTRIES Reuse Capabilities Clinical Template Suite Harmonized Model Content REUSE CAPABILITIES Enabling digitization, traceability, and reuse of content for downstream processes, documents, and registries through the metadata and automation. HARMONIZED MODEL CONTENT Concise, consistent model wording used across multiple documents that aligns with GCP, ICH, requirements and includes feedback from stakeholders and regulators involved in clinical research. CLINICAL TEMPLATE SUITE (CTS) Includes Word and technology-enabled templates for the protocol (CPT/eCPT), statistical analysis plan (SAP/ eSAP), and clinical study report (CSR/eCSR).

The Clinical Content & Reuse (CC&R) Initiative enhanced 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.

Bringing Value to Our Stakeholders

Value to regulators:

  • Increases use of data standards with streamlined structure and content
  • Improves access to protocol information
  • Reduces complexity while easing the review and interpretation by IRBs, Ethics Committees, and Health Authorities across the lifecycle of a clinical trial

Benefits

The Clinical Content & Reuse Initiative enhanced the clinical development process across clinical trial sites, regulators, patients, and sponsors.

Disclaimer

All of the CC&R deliverables (“materials”) are provided ‘AS IS’ WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. TransCelerate and its members do not accept any responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data, or for any indirect consequential loss whatsoever to any person using these materials or acting or refraining from action as a result of the information contained in these materials. Any party using these materials bears sole and complete responsibility for ensuring that the materials, whether modified or not, are suitable for the particular use and are accurate, current, commercially reasonable under the circumstances and comply with all applicable laws and regulations.

Nothing in these documents should be construed to represent or warrant that persons using these documents have complied with all applicable laws and regulations. All individuals and organizations using these documents bear responsibility for complying with the applicable laws and regulations for the relevant jurisdiction.

Related Initiatives

eSource

The eSource Initiative aimed to assist sponsors in overcoming challenges in moving towards more efficient data gathering practices to benefit patients, sites and sponsors.

Digital Data Flow

This initiative aims to advance the drug development process by enabling clinical trial protocol digitalization, helping to move the industry from a document-centric to a data-centric approach. With this change, Digital Data Flow has the potential to reduce cycle times, improve data reliability and quality for sponsors, third party providers, sites and regulators.

Clinical Data Standards

Clinical data are reported by individual trials in various ways which may cause a labor intensive process to gain data insights. The Clinical Data Standards Initiative, in collaboration with CDISC (Clinical Data Interchange Standards Consortium), C-Path (Critical Path Institute), NCI- EVS (National Cancer Institute – Enterprise Vocabulary Service) and FDA as part of the CFAST (Coalition For Accelerating Standards and Therapies), aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and metadata, while improving patient safety and clinical trial outcomes.