Welcome to the Clinical Content & Reuse Initiative Asset Page
The Clinical Content & Reuse (CC&R) Initiative aims to enhance clinical trial processes by developing common content for reuse across clinical trial documents (e.g. CPT, SAP, and CSR). The initiative is working towards having electronic, machine-readable documents and improving overall end-to-end efficiencies.
TransCelerate is excited to announce our 2021 release! In this year’s release, users will find Clinical Template Suite (CTS) content enhancements continuing in the areas of registry automation (ClinicalTrials.gov) & content quality, incorporation of pandemic-related learning, estimand clarifications, as well as user-driven feedback on template clarity. On the technical side, updates were made to the eTemplates technical framework, along with enhancements to the template wizard experience and other authoring interface improvements.
Please find assets below to support the use, implementation, and adoption of the templates. Under each tab, you will find template-specific release updates, guidance documents, and the templates needed to get your organization started!
Tools & Resources
Click on the tabs below for Clinical Content & Reuse information and resources. Translated assets can be found here.
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.
2021 CPT Updates
TransCelerate is excited to release the 2021 version of the CPT/eCPT which is a foundational element of the Clinical Content & Reuse (CC&R) effort.
Since the December 2020 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 2021 Release. Specifically, users will note the following updates to the CPT/eCPT:
Clarification/alignment of estimands considerations & examples across templates, some pandemic-driven flexibility & other user driven content updates
Introduction of new operational/administrative language to address EU CTR expectations
Continuation of registry automation
Terminology clarification/consistency across templates and supporting assets
Updates to liver safety in participant libraries
Technical framework updates and user enhancements to the wizard interfaces
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.
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 technology-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):
The following libraries were updated in the 2021 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.
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.
2021 SAP Updates
TransCelerate is excited to release the 2021 version of the SAP template and eSAP!
Since the December 2020 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 2021 Release.
Highlights of this release include:
Alignment with objective/estimand and statistics sections and general language of the 2021 release of CPT
List of abbreviations moved to the beginning of the document
Removed unclear example for Subgroup Analyses section and instructional text from Interim Analysis 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.
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):
Downloads, guidance, and instructions for the eSAP are on the eTemplates tab.
What is the CSR?
What is the CSR?
2021 CSR Updates
CSR Templates
CSR Foundation and Strategic Alignment
CSR Implementation Tools
Click to navigate between each section
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.
2021 CSR Updates
TransCelerate is excited to release the 2021 version of the CSR template and the eCSR!
Since the December 2020 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 2021 Release.
Highlights of this release include:
Alignment with use of “study intervention” in 2021 release of CPT and SAP
Updated instructional text and suggested text based on company feedback
Added instructional text and suggested text for Quality Tolerance Limits
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.
2. eCSR: The eCSR can be used as a stand-alone template or with the other eTemplates. The eCSR is a technologically-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):
Downloads, guidance, and instructions for the eCSR are on the eTemplates tab.
What are the eTemplates?
What are the eTemplates?
2021 eTemplates Update
eTemplates
Demo Videos
eTemplates Implementation Tools
Click to navigate between each section
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.
TransCelerate is excited to release our 2021 version of the eTemplates as part of the Clinical Content & Reuse (CC&R) efforts.
The 2021 release includes updates to the eCPT, eSAP, and eCSR. Complete details are in the Summary of Changes in 2021 Release. Specifically, the 2021 updates to the eTemplates address the following:
Updates to the technical framework
Enhancements to template wizard experience
Continuation of registry automation
Other authoring user interface improvements
Feedback on the eTemplates is collected on an ongoing basis and used to inform future releases. Have feedback on the eTemplates? Click here.
eTemplates
The eTemplates are technology-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:
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.
Feedback on the Clinical Template Suite Basic Word and eTemplates
Once you have downloaded and reviewed the materials, we would like to receive your feedback at your convenience. Pleaseclick 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.
