Clinical Content & Reuse Solutions

What is the CPT?

The Common Protocol Template (CPT) provides proposed harmonized content and streamlined format for clinical trial protocols. TransCelerate BioPharma, Inc. developed the CPT with input from study investigators, study coordinators, members of institutional review boards (IRB), institutional ethics committees (IEC), the TransCelerate contract research organizations (CRO) Forum, and global regulatory authorities.

The CPT includes a harmonized structure, proposed model text, and regulator-accepted endpoint definitions via therapeutic area libraries that may be used across protocols with little to no editing at the discretion of the user.

The CPT is updated with each release and available in two formats: the Basic Word Edition and the technology-enabled eCPT. Each template can be used independently or in conjunction with other templates in the Clinical Template Suite (CTS) or eTemplates.

Click the image below to see the CPT User Journey through 2019.

Feedback on the CPT template is collected on an ongoing basis and used to inform future releases. Have feedback on the CPT Template? Click click here.

2020 CPT Updates

TransCelerate is excited to release the 2020 version of the CPT/eCPT which is a foundational element of the Clinical Content & Reuse (CC&R) effort.

Since the December 2019 release, we have continued to collect feedback to further improve the utility and sustainability of the CPT/eCPT. In addition, we have worked closely with other TransCelerate workstreams, such as the Clinical Research Access Team to build alignment with registries. Complete details of the changes can be found in the Summary of Changes in 2020 Release. Specifically, users will note the following updates to the CPT/eCPT:

Updated Guidance:

• Estimands are now in the text under the Objectives and Endpoints Table

Automate Registry:

• Instructional text suggestions have been added throughout to align with registries

User-driven Feedback:

• New ‘Arms’ table has been added to the Interventions Section 6.1
• Assessment of Intensity in the Adverse Event section was reviewed and updated to align with the Clinical Data Interchange Standards Consortium (CDISC) definitions

Updated Libraries: Healthy Volunteer, Patient, Pediatrics, Vaccines, Prostate Cancer, Breast Cancer

Feedback on the CPT template will be collected on an ongoing basis and used to inform future releases. Have feedback on the CPT Template? Click here.

CPT Templates

The CPT is the Common Protocol Template. It has a common heading structure, common text, suggested text, and can be used with CPT libraries. The CPT is available in two formats: the Basic Word Edition and the technology-enabled eCPT. A Japanese translation of the CPT is also available.

1. Basic Word Version:

• Getting Started with the Basic Word Editions (MS Word)
• Common Protocol Template (CPT)
• Japanese Translation of the CPT (2020)

2. eCPT:

The eCPT can be used as a stand-alone template or in conjunction with other eTemplates. The eTemplates enable downstream content reuse in documents. The eCPT is a technically-enabled Microsoft (MS) Word formatted template for the protocol and requires the installation of an MS-word add-in. Downloads and instructions for the eCPT can be found on the eTemplates tab.

CPT Foundation and Strategic Alignment

Resources linked below provide context and history of the CPT and the Clinical Template Suite (CTS):

• Why a Common Protocol Template?
• How was the CPT Developed and What Does it Look Like?
• History and Evolution of Clinical Template Suite Releases
• Summary of Changes in 2020 Release
• Update on Use and Maintenance/Governance
• Sponsor Implementation Experience Highlights & Tips
• FAQs

These resources provide information on strategic alignment and disclosures:

• Collaboration with FDA and NIH
• CPT and Disclosure: Connecting Critical Processes
• White Paper: Common Protocol Template and Disclosure to Clinical Trial Registries

CPT Implementation Tools

Implementation Tools for the TransCelerate CPT/eCPT:

• Summary of Changes in 2020 Release
• Summary of Cumulative Content Changes
• Voluntary Adoption Decision Tree
• Resources for Authors
• CPT Mapping Exercise
• Stakeholder Assessment
• Clinical Template Suite Style Guide
• Introduction to the Use of Libraries
• Sponsor Implementation Experience Highlights & Tips
• FAQs
• Comparison Versions (zip file): contains comparison versions for core templates and any updated libraries
• Translated CPT Resources

Downloads, guidance, and instructions and for the eCPT can be found on the eTemplates tab.

Libraries

The following libraries were updated in the 2020 Release: Healthy Volunteer, Patient, Pediatrics, Vaccines, Prostate Cancer, and Breast Cancer.

The remaining eight therapeutic libraries (Alzheimer’s, Asthma, COPD, CV Safety, Diabetes, Diabetic Kidney Disease, Rheumatoid Arthritis, and TQT) were developed or last updated in 2018 to align with the CDISC Therapeutic Area User Guides (TUAGs) and other regulatory guidelines that were available at that time. Due to a low level of usage, TransCelerate will no longer be reviewing or updating these libraries to align with changes to guidance or the structure of the CPT/eCPT.

Caution should therefore be exercised by sponsors when using these libraries to ensure they meet Health Authority/country-specific requirements and align with existing guidance at the time of use.

_{Note: View the CC&R disclaimer here that applies to all libraries. In addition, the libraries for the eCPT are in the add-ins provided.}

What is the SAP?

The Common Statistical Analysis Plan (SAP) template provides a common layout and model content for SAP documentation which seamlessly integrates with the TransCelerate CPT and CSR template.

The SAP is updated with each release and is available in two formats: the Basic Word Edition and the technology-enabled eSAP. Each template can be used independently or with the other templates in the Clinical Template Suite or eTemplates. The templates address global regulatory requirements for reporting, including the ICH E9, ICH E9 (R1), and disclosure.

Feedback on the SAP template is collected on an ongoing basis and used to inform future releases. Have feedback on the SAP Template? Click here.

2020 SAP Updates

TransCelerate is excited to release the third version of the SAP template and the second version of the eSAP!

Since the December 2019 release, we have collected feedback to further improve the content, utility, and sustainability of the SAP template. Complete details are in the Summary of Changes in 2020 Release.

Highlights of this release include:

• Alignment with objective and estimand section and language to the 2020 release of CPT
• Additional estimands are able to be added to the primary estimand section

Feedback on the SAP template is collected on an ongoing basis and used to inform future releases. Have feedback on the SAP Template? Click here.

SAP Templates

The Common Statistical Analysis Plan (SAP) template provides a common layout and model content for SAP documentation which seamlessly integrates with the TransCelerate CPT and CSR template.

The SAP templates are updated with each release and are available in two formats: the Basic Word Edition and the technology-enabled eSAP.

1. Basic Word Version:

• Getting Started with the Basic Word Editions (MS Word)
• SAP Template

2. eSAP:

The eSAP can be used as a stand-alone template or with the other eTemplates. The eSAP is a technically-enabled MS Word formatted template. Downloads and instructions for the eSAP can be found on the eTemplates tab.

SAP Foundation and Strategic Alignment

The resources linked below provide context and history of the SAP and the Clinical Template Suite (CTS):

• How was the SAP Developed and What Does it Look Like?
• SAP Estimands Example Document
• History and Evolution of the Clinical Template Suite Releases
• Summary of Changes in 2020 Release
• Update on Use and Maintenance/Governance
• Sponsor Implementation Experience Highlights & Tips
• FAQs

SAP Implementation Tools

Implementation Tools for the SAP/eSAP:

• Voluntary Adoption Decision Tree
• Summary of Changes in 2020 Release
• Summary of Cumulative Content Changes
• Stakeholder Assessment
• Clinical Template Suite Style Guide
• SAP Mapping Exercise
• SAP Estimands Example Document
• Comparison Versions (zip file): contains comparison versions for core templates and any updated libraries.
• FAQs

Downloads, guidance, and instructions for the eSAP are on the eTemplates tab.

What is the CSR?

The Common Clinical Study Report (CSR) template provides a common and streamlined structure to report data, adhere to global requirements, enable disclosures, and seamlessly integrate with the TransCelerate CPT and SAP templates. The common CSR template does not provide guidance on non-data focused sections such as the benefit/risk interpretation.

The CSR is updated with each release and available in two formats: the Basic Word Edition and the technology-enabled eCSR. Each template can be used independently or with the other templates in the Clinical Template Suite or eTemplates.

Feedback on the CSR template is collected on an ongoing basis and used to inform future releases. Have feedback on the CSR Template? Click here.

2020 CSR Updates

TransCelerate is excited to release the third version of the CSR template and the second version of the eCSR!

Since the December 2019 release, we have collected feedback to further improve the content, utility, and sustainability of the CSR template. Complete details are in the Summary of Changes in 2020 Release.

Highlights of this release include:

• Alignment with the objective and estimand language in 2020 release of CPT and SAP
• Updated instructional text and suggested text based on company feedback (e.g., the addition of recommended summary sub-sections in section 5)
• The supplemental document outlining CSR Considerations for Studies Disrupted by the COVID-19 pandemic

Feedback on the CSR template is collected on an ongoing basis and used to inform future releases. Have feedback on the CSR Template? Click here.

CSR Templates

The Common Clinical Study Report (CSR) template provides a common, streamlined structure to report data, adhere to global requirements, enable disclosures, and seamlessly integrate with the TransCelerate CPT and SAP templates.

The CSR templates are updated with each release and available in two formats: the Basic Word Edition and the technology-enabled eCSR.

1. Basic Word Version:

• Getting Started with the Basic Word Editions (MS Word)
• CSR Template

2. eCSR: The eCSR can be used as a stand-alone template or with the other eTemplates. The eCSR is a technically-enabled MS Word formatted template that facilitates the downstream reuse of content. Downloads and instructions for the eCSR can be found on the eTemplates tab.

CSR Foundation and Strategic Alignment

The resources linked below provide context and history of the CSR template and the Clinical Template Suite (CTS):

• How was the CSR Developed and What Does it Look Like?
• History and Evolution of the Clinical Template Suite Releases
• Summary of Changes in 2020 Release
• Update on Use and Maintenance/Governance
• Sponsor Implementation Experience Highlights & Tips
• FAQs

CSR Implementation Tools

Implementation Tools for the CSR/eCSR:

• CSR Considerations for Studies Disrupted by the COVID-19 Pandemic
• Voluntary Adoption Decision Tree
• Summary of Changes in 2020 Release
• Summary of Cumulative Content Changes
• Stakeholder Assessment
• Clinical Template Suite Style Guide
• CSR Template Mapped to ICH E3 and CORE Guidance
• Comparison Versions (zip file) – Contains comparison versions for core templates and any updated libraries.
• FAQs

Downloads, guidance, and instructions and for the eCSR are on the eTemplates tab.

What are the eTemplates?

The TransCelerate eTemplates consist of the technology-enabled eCPT, eSAP, and eCSR. Each eTemplate can be used independently or together.

The eTemplates are MS word documents with technical functions to enable automation and clinical content reuse to downstream documents, processes, and registries. With the use of metadata and harmonized content, these templates are able to reuse content from document to document through the use of MS-Word add-ins.

Click below to watch a short Clinical Content & Reuse video.

2020 eTemplates Update

TransCelerate is excited to release our 2020 version of the eTemplates as part of the Clinical Content & Reuse (CC&R) efforts.

The 2020 release includes updates to the eCPT, eSAP, and eCSR. Complete details are in the Summary of Changes in 2020 Release. Specifically, the 2020 updates to the eTemplates seek to minimize barriers to adoption by:

• Providing support/guidance on customizing libraries
• Automating registry submissions (ClinicalTrials.gov)
• Aligning with content updates in the CPT, SAP, and CSR
• Improving functionality to accommodate more complex trial designs.

Feedback on the eTemplates are collected on an ongoing basis and used to inform future releases. Have feedback on the eTemplates? Click here.

eTemplates

The eTemplates are technically-enabled MS Word formatted templates that require installation of add-ins. A prerequisite analyzer is needed to assess the workstation environment prior to installation. The add-ins include technical functionality to support content reuse and content for the instructional text.

To get started, download these two assets that apply to all eTemplate files:

• Getting Started with the eTemplates
• Installation Instructions

eTemplates for download:

• eCPT
• eSAP
• eCSR

eTemplates (zip file) is a combined file including the eCPT, eSAP, eCSR and the required MS Word Add-ins and related installation files.

Demo Videos

The CC&R Initiative has created several videos to support the eTemplates. The eTemplates Video Playlist links to a series of videos to support users in installing and navigating the eTemplates.

About Clinical Content & Reuse

Clinical Content & Reuse Demo

Overview and Link to YouTube Playlist

_{*The playlist provides an introductory video plus instructional videos on the functionality of the eTemplates.}

eTemplates Implementation Tools

Foundational Information for eTemplates:

• Getting Started with the eTemplates
• History and Evolution of Clinical Template Suite
• Update on Use and Maintenance/Governance
• Comparison Versions (zip file) – Contains comparison versions for core word templates and any updated libraries

Implementation Tools for the TransCelerate eTemplates:

• eTemplate Implementation Considerations
• IT Considerations for Implementation
• Installation Instructions
• Clinical Template Suite Style Guide
• Stakeholder Assessment
• eTemplates Guidance for Use
• Variable Reuse across eTemplates
• eTemplates Variable Reuse Map
• Creating or Customizing an eTemplate Library
• FAQs

Looking for more context and information on the individual templates? Please refer to the CPT, SAP, CSR tabs.