TransCelerate - Clinical Content & Reuse Assets

Welcome to the Clinical Content & Reuse Initiative Solutions Page

The Clinical Content & Reuse (CC&R) Initiative aims to enhance clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents that can be reused throughout the project lifecycle to enable digitization and traceability through automation.

What’s New

CC&R Initiative & Solutions

With the 2024 Release, the Clinical Template Suite (CTS) continues to reflect state of the art research trends and guidance while successfully reaching its value and impact goals. Those being:

developing harmonized protocol structure and proposed model content
demonstrating value in automation and reuse of selected protocol content
helping to lay a foundation for digitization of the protocol and study design elements

While future plans for CTS template content revisions are evolving, their place in the clinical trial ecosystem is undeniable and download and use by stakeholders continues. We anticipate valuable innovations coming from ICH M11, Digital Data Flow, and the HL7 Vulcan: Utilizing Digital Protocols Project impacting the protocol space and will evaluate future alignment opportunities. As always, use of these assets is completely voluntary and customization/update is left to the discretion of each sponsor.

CTS eTemplates: At this time, no further development or updates to the eTemplates functionality are planned. Because of this, TransCelerate is making the source code for the eTemplate suite available to the public pursuant to an open source license agreement. After clicking to accept the license, individuals can download the code base and supporting materials to aid in their implementation of the CTS eTemplates. Navigate to the eTemplates Tab further down on this page to download the eTemplates Source Code file.

For information relating to ongoing protocol digitization efforts see TransCelerate’s Digital Data Flow initiative here.

2024 Release Summary

The 10th CTS Release & Implementation Toolkit (January 2024) reflects evolved best practices (i.e., master protocols, pregnancy & breastfeeding, reducing gender-specific language, liver safety) as well as other content topics (PRO’s, EU-CTR alignment, Statistical Analyses approach, CTIS) and supports other TransCelerate initiatives by incorporating the MCTC Data Return Plan & PE Study Participation Feedback Questionnaire into the CPT. Additionally, the eTemplates have been updated to address a series of systemic functionality “bugs” that have been identified over the past several releases.

New assets include:

A CTS integrated participant type library for trials enrolling pregnant participants (See CPT Libraries tab)
A basic Word library outlining liver safety considerations for oncology trials (See CPT Libraries tab)
Summary findings from SoA redesign exploration efforts (See Innovation & Collaboration)
A guidance for design considerations for master protocols (See Innovation & Collaboration)

Along with updated CTS assets and Implementation Toolkit resources.

What is Clinical Content & Reuse

CC&R PPT

CC&R PDF

About Clinical Content & Reuse

Click buttons for the expanded CC&R visual.

Click below to watch the Quick Draw video.

Innovation & Collaboration

The Clinical Content & Reuse initiative, in addition to maintaining the CTS, has been involved with numerous innovative exploratory activities & collaborations aimed at enhancing the clinical research ecosystem. Click on the tabs below to learn more & see related tools and resources.

EU-PEARL/Master Protocol

Following a three-year initiative, the IMI sponsored EU-PEARL team released master protocol, ISA, and statistical analysis plan templates based on TransCelerate’s Clinical Template Suite (CPT & SAP templates) as well as other supporting assets. You can find these tools by following this link:

EU-PEARL’s Suite of Master Protocol Templates

Building upon this collaboration, the CC&R team incorporated key recommendations related to master protocol design into the 2024 CPT, and also created a guidance document for design considerations for complex studies.

Planning and Design Considerations for Master Protocols

ACRO/Disrupted Studies

In the Fall of 2020, TransCelerate’s Clinical Content & Reuse Initiative released:

CSR Considerations for Studies Disrupted by the COVID-19 Pandemic

Since that time, both ACRO and TransCelerate member companies have faced unprecedented interruptions to clinical trials caused by an increasingly diverse set of circumstances. ACRO and TransCelerate took their lessons learned and in 2022 published proposals to address these challenges in:

CSR Points to Consider for Disrupted Clinical Trials

SoA Redesign

Over the past two years, the CC&R team has been exploring avenues towards improving Schedule of Activities design with an eye towards digitization.

In 2021, the CC&R Team conducted a proof-of-concept exercise & landscape analysis to determine the general feasibility of establishing a procedures library to support protocol design and digitization. The results of that exercise, aimed at supporting the evolution towards a digitized protocol, have been summarized in a white paper:

Examining Possibilities for a Consistent Procedures Library to Modernize Clinical Trials: A TransCelerate Point of View

In 2022-3, the team explored the possibility of SoA redesign with various stakeholders in mind. A perspective on the future state of the Schedule of Activities and its potential, focusing on redesign toward a “Stakeholder View Approach” to address multiple end user needs, can be found here:

Schedule of Activities Point of View

Download Source Code

CC&R Clickwrap

Name(Required)

First Last

Email(Required)

Marketing Communications Consent

Please sign me up for marketing communications from TransCelerate. Read through our terms before submitting

TRANSCELERATE CLINICAL CONTENT & REUSE INITIATIVE

Click-Wrap License Agreement for eTemplate & Source Code

PLEASE READ THIS AGREEMENT CAREFULLY AS IT GOVERNS YOUR DOWNLOAD AND USE OF THE eTEMPLATE AND THE SOURCE CODE.

This Click-Wrap License Agreement for eTemplate Source Code (this “Agreement”) is a binding contract between TransCelerate BioPharma Inc. (“TransCelerate”) and the individual or type of Person intending to download, install or otherwise use the eTemplate, hereinafter referred to as “Licensee”).

TRANSCELERATE MAKES AVAILABLE THE eTEMPLATE SOURCE CODE SOLELY ON THE TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT AND ON THE CONDITION THAT LICENSEE ACCEPTS AND COMPLIES WITH THEM.

BY CLICKING THE “ACCEPT” BUTTON BELOW, AND/OR BY DOWNLOADING, INSTALLING OR OTHERWISE USING THE eTEMPLATE SOURCE CODE, LICENSEE (A) ACCEPTS THIS AGREEMENT AND AGREES THAT LICENSEE IS LEGALLY BOUND BY ITS TERMS; AND (B) REPRESENTS AND WARRANTS THAT: (I) IF AN INDIVIDUAL, LICENSEE IS 18 YEARS OF AGE OR OLDER; AND (II) LICENSEE HAS THE RIGHT, POWER AND AUTHORITY TO ENTER INTO THIS AGREEMENT AND BIND LICENSEE TO ITS TERMS. IF LICENSEE DOES NOT AGREE TO THE TERMS OF THIS AGREEMENT, TRANSCELERATE WILL NOT AND DOES NOT LICENSE THE eTEMPLATE SOURCE CODE TO LICENSEE AND LICENSEE MUST NOT DOWNLOAD, INSTALL OR USE THE eTEMPLATE SOURCE CODE.

1) Definitions. For purposes of this Agreement, the following terms have the following meanings:

a) “CC&R Template” means the Clinical Template Suite for the Clinical Content & Reuse Initiative available at the TransCelerate Website.

b) “Documentation” means the Implementation Support Resource and Installation Instructions relating to the eTemplate Source Code available for download at the TransCelerate website, and any other documentation made available by TransCelerate relating to the eTemplate Source Code, including user manuals, help files and any other instructions that describe the functionality, installation, implementation, use, maintenance, support, technical features, or requirements of the eTemplate Source Code.

c) “eTemplate” means the technology-enabled template enabled for the CC&R Template as it exists on the effective date of this Agreement and available for download at the TransCelerate website. TransCelerate is not obligated to update, upgrade, enhance or improve the eTemplate and it shall not include any modification, enhancement, update, or revision relating to new releases of the CC&R Template issued by TransCelerate.

d) “eTemplate Source Code” means the source code of the eTemplate as it exists on the effective date of this Agreement and available for download at the TransCelerate website. TransCelerate is not obligated to update, upgrade, enhance or improve the Source Code and it shall not include any modification, enhancement, update, or revision relating to new releases of the eTemplate issued by TransCelerate.

e) “Intellectual Property Rights” means any and all intellectual property or proprietary rights throughout the world, including all: (i) patent rights (including patent applications and disclosures); (ii) registered and unregistered copyrights (including rights in software, including in source code and object code); (iii) registered and unregistered trademark rights; and (iv) trade secret rights.

f) “License” has the meaning set forth in Section 2.

g) “Licensee” has the meaning set forth in the preamble.

h) “Licensee Modifications” means any changes, modifications, enhancements or derivative works of the eTemplate Source Code made by or on behalf of Licensee.

i) “Person” means an individual, corporation, partnership, joint venture, limited liability company, governmental authority, unincorporated organization, trust, association or other entity.

j) “Purpose” means use of the eTemplate Source Code in clinical trial processes.

k) “Term” has the meaning set forth in Section 9.

l) “Third Party” means any Person other than Licensee or TransCelerate.

m) “Third Party Licenses” has the meaning set forth in Section 3.

n) “TransCelerate” has the meaning set forth in the preamble.

2) License Grant and Scope. Subject to and conditioned upon Licensee’s compliance with all of the terms and conditions set forth in this Agreement, TransCelerate hereby grants to Licensee a non-exclusive, non-transferable, non-sublicensable royalty-free limited license (hereinafter, the “License”) during the Term to download and use the eTemplate Source Code and Documentation and make Licensee Modifications solely for the Purpose and subject to the conditions and limitations set forth in Section 4 or elsewhere in this Agreement.

3) Third-Party Software. The eTemplate Source Code may include software, content, data or other materials, including related documentation, that are owned by Persons other than TransCelerate and that are provided to Licensee on terms that are in addition to and/or different from those contained in this Agreement (“Third-Party Licenses”). This License and Licensee’s use of the eTemplate Source Code is subject to such Third Party Licenses. Licensee is bound by and shall comply with all Third-Party Licenses. Any breach by Licensee of any Third-Party License is also a breach of this Agreement.

4) Use Limitations.

a) Licensee shall not use (including make any copies of) the eTemplate Source Code or Documentation beyond the scope of this License.

b) Licensee shall not remove, delete, alter or obscure any trademarks or any copyright, trademark, patent or other Intellectual Property Rights notices from the eTemplate Source Code or Documentation, including any copy thereof.

c) If Licensee incorporates the eTemplate Source Code in any products or its clinical trial processes, Licensee shall provide proper attribution to TransCelerate using the following language “The original eCPT [or eSAP or eCSR] on which this was based was developed by TransCelerate Biopharma, Inc.”

d) Licensee shall not make any public statements indicating partnership with or endorsement by TransCelerate relative to Licensee’s use of the eTemplate Source Code or any Licensee Modifications.

e) If a Licensee Modification is materially different from the eTemplate Source Code, Licensee shall clearly indicate that to avoid a Licensee Modification being misconceived as same or similar to the eTemplate Source Code.

f) Licensee shall not use the eTemplate Source Code or Documentation in violation of any federal, state or local law, regulation or rule.

5) Responsibility for Use of eTemplate Source Code. Licensee is responsible and liable for any use of the eTemplate Source Code, including through access thereto provided by Licensee, directly or indirectly. Specifically, and without limiting the generality of the foregoing, Licensee is responsible and liable for all actions and failures to take required actions with respect to the eTemplate Source Code by its own users or by any other Person to whom Licensee may provide access to or use of the eTemplate Source Code, whether such access or use is permitted by or in violation of this Agreement.

6) Maintenance and Support. There is no obligation on TransCelerate to provide any maintenance or support services with respect to the eTemplate Source Code.

7) Collection and Use of Information. Licensee acknowledges that TransCelerate may, directly or indirectly through the services of Third Parties, track, collect, use and store information regarding Licensee’s download or use of the eTemplate Source Code.

8) Intellectual Property Rights.

a) Ownership of eTemplate and Documentation. Licensee acknowledges and agrees that the eTemplate Source Code and Documentation are provided under license, and not sold, to Licensee. Licensee does not acquire any ownership interest in the eTemplate Source Code or Documentation under this Agreement, or any other rights thereto other than to use the same in accordance with the License, and subject to all of the terms, conditions and restrictions under this Agreement. TransCelerate (and its licensors and service providers) reserve and shall retain their entire right, title and interest in and to the eTemplate Source Code and Documentation and all Intellectual Property Rights arising out of or relating to the eTemplate Source Code and Documentation, except as expressly granted to the Licensee in this Agreement.

b) Duty to Monitor Use. Licensee shall use commercially reasonable efforts to safeguard the eTemplate Source Code and Documentation (including all copies thereof) from misuse or unauthorized access. Licensee shall promptly notify TransCelerate if Licensee becomes aware of any misuse of the eTemplate Source Code or Documentation and fully cooperate with TransCelerate in any action taken by TransCelerate to stop such misuse and to enforce its Intellectual Property Rights.

c) Licensee Modifications. Licensee may make Licensee Modifications in accordance with the terms hereof for commercial and non-commercial use. Notwithstanding anything in this Agreement to the contrary, TransCelerate has no support, warranty, indemnification or other obligation or liability with respect to Licensee Modifications or such modification’s combination, interaction or use with or without the eTemplate Source Code.

9) Term and Termination.

a) This Agreement and the License shall remain in effect unless terminated as set forth herein (the “Term”).

b) Licensee may terminate this Agreement by ceasing to use and destroying all copies of the eTemplate Source Code and Documentation in its possession or control.

c) Either party may, upon written notice to the other party, terminate this Agreement for material breach, provided that such material breach is not cured within thirty (30) days following receipt of such notice.

d) Upon expiration or earlier termination of this Agreement, the License shall automatically terminate immediately, and Licensee shall cease using and destroy all copies of the eTemplate Source Code and Documentation in its possession or control.

e) Notwithstanding any expiration or termination of this Agreement, any provisions of this Agreement which by their terms are intended to survive expiration or termination of this Agreement shall so survive and continue in full force and effect.

10) Warranty Disclaimer. THE eTEMPLATE SOURCE CODE AND DOCUMENTATION ARE PROVIDED TO LICENSEE “AS IS” AND WITH ALL FAULTS AND DEFECTS WITHOUT WARRANTY OF ANY KIND. TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW, TRANSCELERATE, ON ITS OWN BEHALF AND ON BEHALF OF ITS AFFILIATES AND ITS AND THEIR RESPECTIVE LICENSORS AND SERVICE PROVIDERS, EXPRESSLY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE eTEMPLATE SOURCE CODE AND DOCUMENTATION, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT, AND WARRANTIES THAT MAY ARISE OUT OF COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OR TRADE PRACTICE. TRANSCELERATE PROVIDES NO WARRANTY OR UNDERTAKING, AND MAKES NO REPRESENTATION OF ANY KIND THAT THE eTEMPLATE WILL MEET THE LICENSEE’S REQUIREMENTS, ACHIEVE ANY INTENDED RESULTS, BE COMPATIBLE OR WORK WITH ANY OTHER SOFTWARE, APPLICATIONS, SYSTEMS OR SERVICES, OPERATE WITHOUT INTERRUPTION, MEET ANY PERFORMANCE OR RELIABILITY STANDARDS OR BE ERROR FREE OR THAT ANY ERRORS OR DEFECTS CAN OR WILL BE CORRECTED.

11) Limitation of Liability. TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE LAW:

a) IN NO EVENT WILL TRANSCELERATE OR ITS AFFILIATES, OR ANY OF ITS OR THEIR RESPECTIVE LICENSORS OR SERVICE PROVIDERS, BE LIABLE TO THE LICENSEE OR ANY THIRD PARTY FOR ANY USE, INTERRUPTION, DELAY OR INABILITY TO USE THE eTEMPLATE, LOST REVENUES OR PROFITS, DELAYS, INTERRUPTION OR LOSS OF SERVICES, BUSINESS OR GOODWILL, LOSS OR CORRUPTION OF DATA, LOSS RESULTING FROM SYSTEM OR SYSTEM SERVICE FAILURE, MALFUNCTION OR SHUTDOWN, FAILURE TO ACCURATELY TRANSFER, READ OR TRANSMIT INFORMATION, FAILURE TO UPDATE OR PROVIDE CORRECT INFORMATION, SYSTEM INCOMPATIBILITY OR PROVISION OF INCORRECT COMPATIBILITY INFORMATION OR BREACHES IN SYSTEM SECURITY, OR FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL OR PUNITIVE DAMAGES, WHETHER ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, REGARDLESS OF WHETHER SUCH DAMAGES WERE FORESEEABLE AND WHETHER OR NOT TRANSCELERATE WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

b) IN NO EVENT WILL TRANSCELERATE’S AND ITS AFFILIATES’, INCLUDING ANY OF ITS OR THEIR RESPECTIVE LICENSORS’ AND SERVICE PROVIDERS’, COLLECTIVE AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EXCEED ONE-HUNDRED DOLLARS ($100).

c) THE LIMITATIONS SET FORTH IN THIS SECTION 11 SHALL APPLY EVEN IF THE LICENSEE’S REMEDIES UNDER THIS AGREEMENT FAIL THEIR ESSENTIAL PURPOSE.

d) Licensee shall indemnify, defend and hold harmless TransCelerate and its affiliates, including their respective directors, officers, employees, representatives, successors and assigns from and against all claims, costs, damages, losses, liabilities and expenses (including reasonable attorneys’ fees) incurred by any of the foregoing indemnitees arising out of or in connection with Licensee’s breach of the Agreement terms, or operation, use or modification of the eTemplate, the Source Code or any Licensee Modifications.

12) Confidentiality. Each party agrees to use commercially reasonable efforts to maintain the confidentiality of any confidential information of the other party that it obtains pursuant to this Agreement consistent with the efforts such party uses to protect its own confidential and trade secret information of like importance, and shall take all reasonable steps to ensure that such confidential information is not disclosed or distributed by its employees or agents to third parties not subject in writing to an agreement to protect such confidential information. Each party agrees that the eTemplate Source Code and Documentation shall be deemed confidential information of TransCelerate. Licensee shall not disclose the eTemplate Source Code or Documentation to any third party or use it otherwise than strictly in accordance with the terms of this Agreement, provided that this shall not apply to information which is in the public domain through no fault on Licensee’s part or which was disclosed to Licensee without obligation by a third party who is free to disclose the same.

13) Miscellaneous.

a) This Agreement shall be governed by and construed in accordance with the internal laws of the State of Delaware without giving effect to any choice or conflict of law provision or rule (whether of the State of New York or any other jurisdiction) that would cause the application of laws of any jurisdiction other than those of the State of Delaware. Any legal suit, action or proceeding arising out of or related to this Agreement or the matters contemplated hereunder shall be instituted exclusively in the courts within the State of Delaware, and each party irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action or proceeding and waives any objection based on improper venue or forum non conveniens.

b) The relationship between TransCelerate and Licensee established by this Agreement is that of independent contractors. No joint venture or partnership is established by this Agreement. Neither party is the agent, broker, partner, employee, or legal representative of the other for any purpose.

c) All notices, requests, consents, claims, demands, waivers and other communications hereunder shall be in writing and shall be deemed to have been given: (a) when delivered by hand (with written confirmation of receipt); (b) when received by the addressee if sent by a nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile or e-mail of a PDF document if sent during normal business hours of the recipient, and on the next business day if sent after normal business hours of the recipient; or (d) on the third day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid. Such communications must be sent to the respective parties at the addresses as may be designated by a party from time to time.

d) This Agreement, together with all Exhibits hereto constitutes the sole and entire agreement between Licensee and TransCelerate with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter.

e) Licensee shall not assign or otherwise transfer any of its rights, or delegate or otherwise transfer any of its obligations or performance, under this Agreement, in each case whether voluntarily, involuntarily, by operation of law or otherwise, without TransCelerate’s prior written consent, which consent TransCelerate may give or withhold in its sole discretion. For purposes of the preceding sentence, and without limiting its generality, any merger, consolidation or reorganization involving Licensee (regardless of whether Licensee is a surviving or disappearing entity) will be deemed to be a transfer of rights, obligations or performance under this Agreement for which TransCelerate’s prior written consent is required. No delegation or other transfer will relieve Licensee of any of its obligations or performance under this Agreement. Any purported assignment, delegation or transfer in violation of this Section is void. TransCelerate may freely assign or otherwise transfer all or any of its rights, or delegate or otherwise transfer all or any of its obligations or performance, under this Agreement without Licensee’s consent. This Agreement is binding upon and inures to the benefit of the parties hereto and their respective permitted successors and assigns.

f) This Agreement is for the sole benefit of the parties hereto and their respective successors and permitted assigns and nothing herein, express or implied, is intended to or shall confer on any other Person any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

g) This Agreement may only be amended, modified or supplemented by an agreement in writing signed by each party hereto. No waiver by any party of any of the provisions hereof shall be effective unless explicitly set forth in writing and signed by the party so waiving. Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any right, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

h) If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction.

i) For purposes of this Agreement, (a) the words “include,” “includes” and “including” shall be deemed to be followed by the words “without limitation”; (b) the word “or” is not exclusive; and (c) the words “herein,” “hereof,” “hereby,” “hereto” and “hereunder” refer to this Agreement as a whole. This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the party drafting an instrument or causing any instrument to be drafted. All exhibits referred to herein shall be construed with, and as an integral part of, this Agreement to the same extent as if they were set forth verbatim herein.

j) The headings in this Agreement are for reference only and shall not affect the interpretation of this Agreement.

[End of Document]

CTS Tools & Resources

The CTS is provided as a free resource and was developed along with the associated Implementation Toolkit to be a self-service set of materials. Click on the tabs below for Clinical Template Suite (CTS) 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!

Recent Industry Presentations:

Ready to take action? Let’s get started:

CTS Implementation Support Resource (Contains content on multiple topics: General/Background, History & Evolution, Implementation Considerations, Post Implementation Decision)
FAQs

What is the CPT?

2024 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) 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 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.

2024 CPT Updates

TransCelerate is excited to release the 2024 version of the CPT/eCPT which is a foundational element of the Clinical Content & Reuse (CC&R) effort.

Since the Fall 2021 release, we have focused on incorporating evolved best practices (i.e., master protocols, pregnancy & breastfeeding, reducing gender-specific language, liver safety) as well as other content topics (PRO’s, EU-CTR alignment, Statistical Analyses approach, CTIS). Additionally, updates support other TransCelerate initiatives by incorporating the MCTC Data Return Plan & PE Study Participation Feedback Questionnaire into the CPT. Complete details of the changes can be found in the Summary of Changes in 2024 Release.

New Libraries: Pregnant Participants, Liver Safety for Oncology (BWE Version Only)

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

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:

Common Protocol Template (CPT)
Japanese Translation of the CPT (2021)
CTS Implementation Support Resource (See content on Getting Started with the CTS Basic Word Editions)

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 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) as well as information on strategic alignment and disclosures:

CPT Implementation Tools

Implementation Tools for the TransCelerate CPT/eCPT:

Summary of Changes in 2024 Release
Summary of Cumulative Content Changes
CTS Implementation Support Resource (Contains content on multiple topics: General/Background, History & Evolution, Implementation Considerations, Post Implementation Decision)
Resources for Authors
CTS Mapping Worksheet
Clinical Template Suite Style Guide
FAQs
Comparison Versions (zip file): contains comparison versions for core templates and any updated libraries
Translated CPT Resources

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

Libraries

Participant Libraries

Other Library Types

CV-Safety
Vaccines
Liver Safety in Oncology (BWE Version Only)

Therapeutic Libraries

Along with the new Pregnant Participants Library, the following libraries were updated in the 2024 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?

2024 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 templates.

The SAP 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.

2024 SAP Updates

TransCelerate is excited to release the 2024 version of the SAP template and eSAP!

Since the Fall 2021 release, we have optimized content across the template suite with an eye towards sustainability. Specifically for the SAP, updates were focused on better alignment of the statistical analyses approach to support estimands requirements.

Complete details are in the Summary of Changes in 2024 Release.

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 templates.

The SAP template is available in two formats: the Basic Word Edition and the technology-enabled eSAP.

1. Basic Word Version:

SAP Template
CTS Implementation Support Resource (See content on Getting Started with the Basic Word Editions)

2. eSAP:

The eSAP can be used as a stand-alone template or with the other eTemplates. The eSAP is a technology-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):

CTS Implementation Support Resource (Contains content on multiple topics: General/Background, History & Evolution, Implementation Considerations, Post Implementation Decision)
SAP Estimands Example Document
FAQs

SAP Implementation Tools

Implementation Tools for the SAP/eSAP:

Summary of Changes in 2024 Release
Summary of Cumulative Content Changes
CTS Implementation Support Resource (Contains content on multiple topics: General Background, History & Evolution, Implementation Considerations, Post Implementation Decision)
Clinical Template Suite Style Guide
CTS Mapping Worksheet
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?

2024 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 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.

2024 CSR Updates

TransCelerate is excited to release the 2024 version of the CSR template and the eCSR!

Since the Fall 2021 release, we have optimized content across the template suite with an eye towards sustainability. Additional changes to the CSR have reflected EU-CTR requirements and maintaining alignment with CPT content updates. Complete details are in the Summary of Changes in 2024 Release.

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 template is available in two formats: the Basic Word Edition and the technology-enabled eCSR.

1. Basic Word Version:

CSR Template
CTS Implementation Support Resource (See content on Getting Started with the Basic Word Editions)

2. eCSR: The eCSR can be used as a stand-alone template or with the other eTemplates. The eCSR is a technology-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):

CTS Implementation Support Resource (Contains content on multiple topics: General/Background, History & Evolution, Implementation Considerations, Post Implementation Decision)
FAQs

CSR Implementation Tools

Implementation Tools for the CSR/eCSR:

Summary of Changes in 2024 Release
Summary of Cumulative Content Changes
CTS Implementation Support Resource (Contains content on multiple topics: General/Background, History & Evolution, Implementation Considerations, Post Implementation Decision)
CSR Considerations for Studies Disrupted by the COVID-19 Pandemic
CSR Points to Consider for Disrupted Clinical Trials
Clinical Template Suite Style Guide
CSR Template Mapped to ICH E3 and CORE Guidance
CTS Mapping Worksheet
Comparison Versions (zip file) – Contains comparison versions for core templates and any updated libraries.
FAQs

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

What are the eTemplates?

2024 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.

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

2024 eTemplates Update

TransCelerate is excited to release our 2024 version of the eTemplates as part of the Clinical Content & Reuse (CC&R) efforts.

The 2024 release includes updates to the eCPT, eSAP, and eCSR. Complete details are in the Summary of Changes in 2024 Release. Specifically, the updates to the eTemplates address the following:

New Participant Type Library: Pregnant Participants
Resolution of performance “bugs” identified by end-users and testing activities

eTemplates

The eTemplates are technology-enabled MS-Word formatted templates that require installation of add-ins. A prerequisite analyzer can be used 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:

CTS Implementation Support Resource (See content on Getting Started with the eTemplate Editions)
Installation Instructions

eTemplates for download:

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

eTemplates Source Code

While the Source Code is not required to utilize the CTS eTemplates, for those wishing to customize their use, TransCelerate has made the 2024 Release version of the eTemplates Source Code publicly available. Following acknowledgement of use requirements via the embedded license agreement, individuals can download the code base and supporting materials to aid in their implementation of the CTS eTemplates.

test

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:

Summary of Changes in 2024 Release
CTS Implementation Support Resource (Contains content on multiple topics: General/Background, History & Evolution, Implementation Considerations, Post Implementation Decision)
Installation Instructions
Clinical Template Suite Style Guide
eTemplates Guidance for Use (Extensive “hands-on” user manual to support the use of the eTemplates)
eTemplates Variable Reuse Map
Creating or Customizing an eTemplate Library
FAQs
Comparison Versions (zip file) – Contains comparison versions for core word templates and any updated libraries.

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

View the CC&R disclaimer here.

Disclaimer

All of the CC&R deliverables (“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.

CC&R Feedback

IS THERE ANYTHING IN THE ORGANIZATION OR CONTENT THAT WOULD PREVENT YOU FROM USING THE BASIC WORD OR ELECTRONIC CLINICAL TEMPLATE SUITE (e.g., CPT, SAP, AND/OR CSR)?*
PLEASE PROVIDE FEEDBACK OR SUGGESTIONS FOR IMPROVING THE BASIC WORD AND/OR ELECTRONIC TEMPLATES OF THE CPT, SAP, AND CSR.*
Is it okay for a representative from TransCelerate to contact you for further feedback or clarification?*
- Yes
- No
First Name (Optional) Last Name (Optional)
Email (optional)
- By clicking this box, I give TransCelerate permission to contact me in the future via e-mail regarding this feedback.
- By clicking this box, I give TransCelerate permission to publish my responses in whole or in part in TransCelerate deliverables or publications related to this project. (www.transceleratebiopharmainc.com).
Please click the CAPTCHA button below to proceed

Welcome to the Clinical Content & Reuse Initiative Solutions Page

What’s New

What is Clinical Content & Reuse

About Clinical Content & Reuse

Click buttons for the expanded CC&R visual. Click below to watch the Quick Draw video.

Innovation & Collaboration

CC&R Clickwrap