Common Protocol Template

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About the TransCelerate CPT

November 2018 - Release Highlights

We are excited to release our latest version of the CPT. Since December 2017, we have continued to collect feedback to further improve the utility and sustainability of the CPT. In this release, we are aligning to the EU Clinical Trial Regulations, recent updates to ICH regulations (E6 and E9), and continue to align with the Protocol Template developed by the National Institutes of Health (NIH) and US Food and Drug Administration (FDA).

For the first time, we are also releasing the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR) Basic Word Edition templates. With this release, we are taking an important first step in enabling the automation of downstream processes and improved reuse of content. Click below to see more details.

Click on the appropriate icon below for information on content changes, library updates, and enhancements for the Technology-Enabled Edition of the CPT as well as several new resources for the Common Statistical Analysis Plan (SAP) and Common Clinical Study Report (CSR).
CONTENT CHANGES LIBRARY UPDATES TECHNOLOGYENHANCEMENTS SUPPORTING TOOLSAND RESOURCES
  • Enable use in device and vaccine trials
  • EU Clinical Trial Regulation analysis and alignment
  • ICH E6 [R2] and E9 [R1] alignment
  • More robust statistical analysis content, including the use of estimands
  • Updates based on FDA and EMA feedback
  • Summary of Changes in November 2018 Release
New libraries available:
Technology enhancements are a top priority for the CPT team. In this release you can find:
  • Improved authoring functionality (i.e., co-authoring, track-changes, support for variable text, management of intervention group, and registry identifier tables).
  • Improved access to contraceptive related language from libraries.
  • Capability to store and manage CPT library files in a central location (i.e., SharePoint).

Tools and Resources

Click Here For Translated Resources.
Technology-Enabled Edition Templates and Guidelines
File
Description
Step-by-step guidance for accessing the Technology-Enabled Edition.
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.
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.
Provides scenarios and IT support considerations when implementing the CPT Technology-Enabled Edition in your organization.
Technology-Enabled Edition Demo Videos
Instructional videos may be based on a prior version of the CPT.
Playlist provides an introductory video plus 14 instructional videos on the functionality of the Technology-Enabled Edition.
Basic Word Edition Templates and Guidelines
File
Description
Step-by-step guide for starting with the Basic Word Edition of the CPT, SAP and CSR.
MS Word enabled format and content template for the protocol, containing a common heading structure, common text, suggested text, and CPT libraries. Includes a prerequisite analyzer to assess the environment prior to installation. Requires installation of template and add-ins on your workstation.
MS Word enabled format and content template for the SAP.
MS Word enabled format and content template for the CSR.
Defines color coding used to distinguish common, suggested, example, and instructional text.

Participant and Therapeutic Area Libraries

Informational and Implementation Materials

Feedback on the Common Templates

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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