Clinical Content & Reuse

Clinical Content & Reuse (CC&R) Initiative, formerly known as Common Protocol Template (CPT), aims to enhance clinical trial processes by developing common content for reuse across clinical trial documents in the Clinical Template Suite (CTS).

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. 

Master Protocol Design & Implementation Survey

What’s New

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.

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 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.

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

Increased use of CPT across Sponsors brings value to sites by:

  • Streamlining the structure and content thus improving access to protocol information and increasing consistency across sponsors
  • Providing easy access to the schedule of assessments, establishing clear alignment between objectives and endpoints
  • Enabling references to documents that facilitate study conduct (e.g., study manuals, pharmacy guides, etc.) to avoid duplicative and lengthy protocol sections

Increased use of common clinical content in the protocol can also have a positive impact on patients by:

  • Improving access to protocol information
  • Facilitating efficiencies across protocol development and implementation processes so that clinical and medical staff can focus on the patient

Benefits for Sponsors:

  • The CPT was designed with data standards and libraries and includes regulatory and site feedback aimed at easing submission to health authorities and ethics committees
  • The Clinical Template Suite includes the SAP and CSR templates, which are aligned to the CPT and ready for use and implementation
  • The eTemplates enable digitization and reuse of content for downstream processes, documents, and registries


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

Implementation Experience

As solutions are used throughout the R&D ecosystem, TransCelerate receives feedback related to solution implementation experiences. Anyone can submit an experience through the Engage with Us page and in select cases, we share the experiences on Our Impact page in a blinded way. Below is a featured example for this initiative:

Available Solutions

Please see the Initiative Solutions page for guidance and to download our Clinical Template Suite.


These 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


The eSource Initiative seeks to assist TransCelerate Member Companies, and ultimately other trial sponsors, in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.

Digital Data Flow

This initiative aims to move the drug development process from a current state of manual, study start-up asset creation (i.e. Case Report Forms, Procedure Manuals, Statistical Analysis Plans, and Schedule of Activities) to a future state of fully-automated, dynamic, study start-up readiness via an open-sourced, vendor-agnostic technical solution that will reduce cycle times and improve data 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.

CC&R Feedback