Common Protocol Template

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What is the Common Protocol Template (CPT)?

The Common Protocol Template (CPT) is a harmonized and streamlined approach to the format and content of clinical trial protocols. It aims to ease interpretation by the study sites and global regulatory authorities while enabling downstream automation of many clinical processes and aligning to industry data standards.

TransCelerate BioPharma, Inc. developed the CPT with input from investigators, study coordinators, members of IRBs, IECs, the TransCelerate CRO Forum, and global health authorities. The CPT includes a common structure, common text, and regulator-accepted endpoint definitions that may be used across protocols with little to no editing at the discretion of the user. The first CPT was released in 2015 and it has been evolving ever since. The use of this template is at the discretion of the user.

View the disclaimer here.

Guiding Principles for the Common Protocol Template

Structure Must...
  • Be streamlined
  • Be consistent
Content Must...
  • Develop common wording
  • Align with GCP, ICH & EU requirements
  • Allow for all phases & study types
Endpoints Must...
  • Map to an objective
  • Support use of CDISC TA standards

December 2017 - CPT Release Highlights

We’re excited to release our latest version of the CPT. Since May 2017, the CPT Initiative collected feedback to further improve the utility and sustainability of the CPT following alignment with the Protocol Template developed by the National Institutes of Health (NIH) and US Food and Drug Administration (FDA).

Click on the appropriate icon below for information on content changes, newly added libraries, enhancements for the Technology-Enabled Edition of the CPT and how TransCelerate is supporting disclosure data uploads into clinical trial registries.
CONTENT CHANGES(SINCE MAY 2017) LIBRARY UPDATES TECHNOLOGYENHANCEMENTS SUPPORTING TOOLSAND RESOURCES
A high-level overview of the content changes since May 2017 include:
  • Contraceptive and barrier language, including a new decision tree
  • Support for disclosure data uploads into clinical trial registries
  • Updates based on FDA feedback
  • Updates based on the ICH E6 (R2) Addendum
  • Summary of Changes in December 2017 Release
From the December 2017 release, five new Therapeutic Area libraries are available:
The technology enhancements are a top priority for the CPT team. In this release you can find:
  • Addition of Enhanced Export Interface
  • Updates for an export option of then 47 ClinicalTrials.gov variables & full protocol content

Common Protocol Template Tools and Resources

Click Here For Translated Resources.
Technology-Enabled Edition Template and Guidelines
File
Description
Step-by-step guidance for accessing the Technology-Enabled Edition
MS Word enabled format and content template for the protocol, containing a common heading structure, common text, suggested text, and all CPT libraries. Includes a prerequisite analyzer to assess the environment prior to installation. Requires installation of template and add-ins on your workstation.
Brief instructions for installing the tech-enabled edition on your workstation.
Guide to assist with utilization of the CPT Technology-Enabled Edition and MS Work add-ins.
Provides scenarios and IT support considerations when implementing the CPT Technology-Enabled Edition in your organization.
Playlist provides an introductory video plus 14 instructional videos on the functionality of the Technology-Enabled Edition.
Basic Word Edition Template and Guidelines
File
Description
Step-by-step guide for starting with the Basic Word Edition of the CPT
MS Word enabled format and content template for the protocol, containing a common heading structure, common text, suggested text, and all CPT libraries. Includes a prerequisite analyzer to assess the environment prior to installation. Requires installation of template and add-ins on your workstation.
Defines color coding used within the CPT to distinguish common, suggested, example, and instructional text

Participant and Therapeutic Area Libraries

Feedback on the Common Protocol Template

Once you have downloaded and reviewed the materials, we would like to receive your feedback at your convenience. Please click here to submit a response. We look forward to reviewing your comments.

Disclaimer

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.

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