TransCelerate - Clinical Content & Reuse Assets

Welcome to the Clinical Content & Reuse Initiative Solutions Page

The Clinical Content & Reuse (CC&R) Initiative has enhanced 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: 2026

CPT Re-aligned to ICH M11 Template

To maximize value for stakeholders who have adopted the CPT over the past 12 years, TransCelerate member company SMEs have aligned the Common Protocol Template (CPT) Basic Word edition with the finalized ICH M11 Protocol Template and Technical Specifications now available publicly, as well as to the Unified Study Definitions Model (USDM) developed by CDISC and the DDF Initiative. Use of this CPT V11 as a foundation for protocol development will align with key elements of the new ICH M11 standard while still utilizing the additional granularity and detail stakeholders have found valuable in the CPT for the past 12 years.

The template is now available, along with the supporting overview and reference materials outlined below:

Common Protocol Template V011

Active Participant Type and Therapeutic Area Libraries

CPT/ICH M11 Alignment Overview

Cumulative Summary of Content Changes

Resources for Authors

CTS Implementation Support Resource (ISR)

FAQs

Clinical Template Suite Style Guide

Estimands Example Document

Note: Since V11 CPT updates were only made to the Basic Word edition, Release 10 (2024) versions of all templates are still available and can be accessed by anyone wishing to leverage the content reuse capabilities established across CTS templates in earlier versions.

CTS eTemplates: At this time, no further development or updates to the eTemplates functionality are planned post Rleease 10 (2024). Because of this, TransCelerate has made 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 below to download the eTemplates Source Code file.

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

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, was 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

Learn more about the unique and impactful collaboration between TransCelerate’s Clinical Content & Reuse (CC&R) initiative and the Innovative Medicine Institute’s (IMI) EU-PEARL initiative.

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

From 2021 to 2023, the CC&R team explored avenues towards improving Schedule of Activities design with an eye towards digitization.

In 2021, the 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

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CC&R Clickwrap

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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.

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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.

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

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

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13) Miscellaneous.

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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!

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?

2026 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 (2024 is the final edition). 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.

2026 CPT Updates

With the 2026 Release of CPT, TransCelerate continues to support protocol digitization efforts by aligning the CPT structure and content with the publicly available ICH M11 Protocol Template standard and the Unified Study Definitions Model (USDM). Stakeholders can continue to leverage the value they have derived from CPT over the years.

To learn about the CPT/ICH M11 alignment exercise refer to the CPT/ICH M11 Alignment Overview and the Cumulative Summary of Content Changes.

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.

1. Basic Word Version:

Common Protocol Template (CPT)
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. Note: Maintenance and support for eCTS was suspended following the January 2024 release.

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:

Cumulative Summary of 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

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

Note: Maintenance and support for eCTS was suspended following the January 2024 release.

Libraries

Eight “active” libraries have been revised to align with the ICH M11-aligned CPT V011. These include:

Participant Libraries

Therapeutic Libraries

Other Library Types

Vaccines
Liver Safety in Oncology (BWE Version Only)

_{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?

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.

Note: The 2024 Release of the Clinical Template Suite was the last version to align all 3 basic word edition and etemplates (CPT/SAP/CSR & eCPT/eSAP/eCSR). Those wishing to explore content reuse across these template versions can find the legacy files 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 templates.

The SAP 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 that facilitates the downstream reuse of content. Downloads and instructions for the eSAP can be found on the eTemplates tab.

SAP Foundation and Strategic Alignment

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)
Estimands Example Document
FAQs

SAP Implementation Tools

Implementation Tools for the SAP/eSAP:

Cumulative Summary of 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
Estimands Example Document
FAQs

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

Note: Maintenance and support for eCTS was suspended following the January 2024 release.

What is the CSR?

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.

Note: The 2024 Release of the Clinical Template Suite was the last version to align all 3 basic word edition and etemplates (CPT/SAP/CSR & eCPT/eSAP/eCSR). Those wishing to explore content reuse across these template versions can find the legacy files 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 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:

Cumulative Summary 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
FAQs

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

Note: Maintenance and support for eCTS was suspended following the January 2024 release.

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

The 2024 CTS Release was the final update to the CTS eTemplates.

The 2024 release included updates to the eCPT, eSAP, and eCSR. Complete details are in the Summary of Changes in 2024 Release. Specifically, the updates to the eTemplates addressed 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.

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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

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

These deliverables 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 deliverables or acting or refraining from action as a result of the information contained in these deliverables. Any party using these materials bears sole and complete responsibility for ensuring that the deliverables, 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 deliverables should be construed to represent or warrant that persons using these deliverables have complied with all applicable laws and regulations. All individuals and organizations using these deliverables bear responsibility for complying with the applicable laws and regulations for the relevant jurisdiction.

Welcome to the Clinical Content & Reuse Initiative Solutions Page

What is Clinical Content & Reuse

About Clinical Content & Reuse

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Innovation & Collaboration

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