Clinical Content & Reuse: Learn More

Clinical Content & Reuse Solutions

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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. The initiative is working towards having electronic, machine-readable documents and improving overall end-to-end efficiencies.

Guiding Principles for Clinical Content & Reuse
Structure must:

  • Be streamlined
  • Be consistent
 Content must:

  • Develop common wording for use across multiple documents or processes
  • Align with GCP, ICH & EU requirements
About Clinical Content & Reuse

Basic word and electronic templates for the common protocol (CPT), statistical analysis plan (SAP), and clinical study report (CSR) are available below along with resources to support their use, implementation, and adoption in clinical trials. The templates can be used individually or together to achieve content reuse.

CSR Considerations for Studies Disrupted by the COVID-19 Pandemic

TransCelerate announces a new asset, CSR Considerations for Studies Disrupted by the COVID-19 Pandemic (Updated with Sample Text), now available for download. This document was created by clinical scientists, pharmacovigilance experts, data scientists, and other experts to identify the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports due to disruptions caused by COVID-19. At this time, no further updates to this content are planned, though TransCelerate will be seeking further input from experts and regulators to guide CSRs for studies disrupted by COVID-19.

2019 Release Highlights

TransCelerate is excited to announce that the Common Protocol Template (CPT) is now a foundational component of the newly formed Clinical Content & Reuse Initiative. Since November 2018, we have collected feedback to further improve the utility and sustainability of the CPT, SAP, and CSR. We are now releasing our first version of the eTemplates along with updated versions of the previously available word editions!

The assets below have been created to support the use, implementation, and adoption of the Clinical Template Suite (CTS) and eTemplates. 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.

Introductory and Implementation Materials

Clinical Template Suite (CTS);
Template, Resources, and Use Guidance

CPT

SAP

CSR

eTemplates (eCPT, eSAP, eCSR)

Welcome!

Ready to take action? Let’s get started:

What is the CPT?

What is the CPT?

2019 CPT Updates

CPT Templates

CPT Foundation and Strategic Alignment

CPT Implementation Tools

Libraries

Click to navigate between each section

What is the CPT?

The Common Protocol Template (CPT) is a harmonized and streamlined approach to the format and content of clinical trial protocols. TransCelerate BioPharma, Inc. developed the CPT with input from investigators, study coordinators, members of IRBs, IECs, the TransCelerate CRO Forum, and regulatory authorities. The CPT includes a common 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 available in two formats: the Basic Word Edition and the eCPT. Each template can be used independently or in conjunction with the Clinical Template Suite or eTemplates.

Click the image below to see the CPT User Journey by Year

2019 CPT Updates

TransCelerate is excited to release our 2019 version of the CPT which is a foundational element of the Clinical Content & Reuse (CC&R) efforts.

Since the November 2018 release, we have continued to collect feedback to further improve the utility and sustainability of the CPT/eCPT. We have also worked closely with other TransCelerate workstreams, like the Clinical Research Access Team to build alignment. Complete details can be found in the Summary of Changes in 2019 Release. Specifically, users will note updates to the CPT:

Language:
  • Liver safety stopping criteria
  • Contraception and Pregnancy
  • Quality Tolerance (QTL)
Specific sections:
  • Title page and Synopsis
  • Study Intervention(s) and Concomitant Therapy
  • Stats
  • Medical Device definitions and Adverse Event reporting
Libraries:
  • Healthy Volunteer
  • Patient
  • Pediatrics
  • Vaccines

A high-level summary of the eCPT updates can be found here. Feedback on the CPT will be collected on an ongoing basis and used to inform future releases. Have feedback on the CPT? 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 eCPT.

1. Basic Word Version:

2. eCPT:

The eCPT can be used as a stand-alone template or in conjunction with the eTemplates. The eCPT is a technically-enabled 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):

These resources provide information on strategic alignment and disclosures:

CPT Implementation Tools

Implementation Tools for the TransCelerate CPT/eCPT:

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

Libraries

Participant Libraries
Therapeutic Libraries
Other Library Types

Note: The libraries for the eCPT are in the add-ins provided.

What is the SAP?

What is the SAP?

2019 SAP Updates

SAP Templates

SAP Foundation and Strategic Alignment

SAP Implementation Tools

Click to navigate between each section

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 template is aligned with ICH E9 and ICH E9 (R1) (at ICH Step 3) for the use of Estimands. In addition, the template addresses global regulatory requirements for reporting and disclosure.

The SAP is available in two formats: the Basic Word Edition and the eSAP. Each template can be used independently or with the other templates in the Clinical Template Suite or eTemplates.

2019 SAP Updates

TransCelerate is excited to release the second publicly-available version of the SAP template and the first version of the eSAP!

Since the November 2018 release, we have continued to collect feedback to further improve the content, utility, and sustainability of the SAP. Complete details are in the Summary of Changes in 2019 Release.

This release includes updates to the model language and instructions that align with ICH E9 (R1) (at ICH Step 3) for the use of Estimands.

Feedback on the SAP Template will be 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 available in two formats: the Basic Word Edition and the eSAP.

1. Basic Word Version:

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):

SAP Implementation Tools

Implementation Tools for the SAP/eSAP:

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

What is the CSR?

What is the CSR?

2019 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 aims to provide a lean, common, and streamlined structure to report data (e.g., no benefit/risk interpretation) and seamlessly integrates with the TransCelerate CPT and SAP template.

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

 

 

2019 CSR Updates

TransCelerate is excited to release the second publicly-available version of the CSR template and the first version of the eCSR!

Since the November 2018 release, we have continued to collect feedback to further improve the content, utility, and sustainability of the CSR template. Complete details are in the Summary of Changes in 2019 Release.

Highlights of this release include:

  • Alignment with this release of CPT
  • Updated instructional and suggested text
  • Alignment with CORE, in addition to alignment with ICH E3 (previous release).
  • eCSR functionality to create an abbreviated or synoptic-style report based on a user’s needs.

Feedback on the CSR Template will be 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 aims to provide a lean, common, and streamlined structure to report data (eg, no benefit/risk interpretation) and seamlessly integrates with the TransCelerate CPT and SAP template.

The CSR templates are available in two formats: the Basic Word Edition and the eCSR.

1. Basic Word Version:

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. 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):

CSR Implementation Tools

Implementation Tools for the CSR/eCSR:

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

What are the eTemplates?

What are the eTemplates?

2019 eTemplates Update

eTemplates

Demo Videos

eTemplates Implementation Tools

Click to navigate between each section

What are the eTemplates?

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

The eTemplates are 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 Content Reuse video.

Clinical Content & Reuse Demo

2019 eTemplates Update

TransCelerate is excited to release our 2019 version of the eTemplates as part of the Clinical Content & Reuse (CC&R) efforts. The 2019 release represents the first time, the eSAP and eCSR are publicly available along with the latest edition of the eCPT!

Please see the Summary of eTemplate Changes in 2019 Release for specific information.

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:

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

eTemplates for download:

 

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

Implementation Tools for the TransCelerate eTemplates:

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

View the CC&R disclaimer here.

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. 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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