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Initiative Solution Description Initiative
A Clinical QMS Overview Infographic Our Clinical QMS Overview Infographic gives a quick snapshot into our conceptual framework. Quality Management System
A Framework for Rapid Signal Assessment Using Real-World Data Provides an end-to-end high-level process map on using RWD as an option to more rapidly conduct safety signal assessments. It includes a series of elements/components designed to additionally help stakeholders have a common understanding and communication of concepts and processes for RSA RWD.    Rapid Signal Assessment Using Real World Data
A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle A Framework including a comparison of requirements for presentation of risks across the guidelines and phases of the product lifecycle, along with operational considerations on how to present risks in key regulatory/safety documents. Interpretation of Pharmacovigilance Guidances & Regulations
A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle & Overview Video A Framework including a comparison of requirements for presentation of risks across the guidelines and phases of the product lifecycle, along with operational considerations on how to present risks in key regulatory/safety documents. Accompanying this framework is an overview video that covers key aspects of the framework. Interpretation of Pharmacovigilance Guidances & Regulations
A Knowledge Management Framework and Approach for Clinical Development (Paper) Describes a framework for effective knowledge management within clinical development. Includes a suite of change management tools. Quality Management System
A Model Approach and De-Identification and Anonymization of Individual Patient Data in Clinical Studies (Paper) Provides guidance and model approaches for redacting privacy information found in clinical study reports, anonymizing patient level data shared with the broader healthcare community and preparing and distributing layperson summaries to the general public and study participants. Now maintained by PHUSE. Clinical Data Transparency
A Privacy Framework for Clinical Data Reuse: Secondary Data Use in the Pharmaceutical Industry A framework intended to provide a set of principles and best practice processes for secondary research based on clinical data, a glossary, and reuse use cases. Privacy Methodology for Data Sharing
About Clinical Content & Reuse Video explaining rationale and advantages of common structure, language of templates which supports content reuse. Clinical Content & Reuse
Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges (Paper) This paper is a pharmaceutical industry perspective on opportunities and challenges with adoption and implementation of patient technology in clinical trials. Patient Technology
Accelerating the Adoption of eSource in Clinical Research: A TransCelerate Point of View (Paper) Provides a detailed assessment of the current state in the industry and opportunities to increase eSource adoption through four essential modalities. eSource
Alzheimer’s Therapeutic Area library for Alzheimer's trials. Clinical Content & Reuse
An Overview of A Privacy Framework for Clinical Data Reuse Video A video on the key aspects of TransCelerate's GDPR data reuse framework, including principles for reuse of clinical data, a glossary, use cases, and a best practice process. Privacy Methodology for Data Sharing
Approaches to Implementing the Nonclinical Common Templates in Your Organization A resource to support an organization’s efforts in determining if and how the organization will adopt the nonclinical protocol template. Nonclinical Common Report Template
Artificial Intelligence-Based Validation Case Study Themes Provides themes and considerations from use cases focused on early adopters' experiences applying AI to pharmacovigilance applications. Intelligent Automation Opportunities in Pharmacovigilance
Assessing a Clinical QMS Tool A set of survey questions and additional considerations on how an organization may begin to assess the state of their own clinical QMS in alignment with the TransCelerate conceptual model or may also be customized by company to align to their implemented model. Allows organizations to assess the initial current state of their Clinical QMS in alignment with the TransCelerate conceptual model; may also be used as a periodic assessment tool to allow organizations to focus on improvement in specific areas they deem high priority. Quality Management System
Assuring Audit & Inspection Readiness-Consideration for the Use of RWD & RWE in Regulatory Decision-Making This list of key considerations for RWD quality has been developed to assist researchers interested in using RWD for regulatory decision-making. Its purpose is to provide greater clarity as to the type of information and documentation regulators may request from data providers and sponsors of research about the sources and process by which RWD/RWE is compiled to inform a regulatory decision. Real World Data
Assuring Audit & Inspection Readiness-Considerations for the Use of RWD & RWE in Regulatory Decision-Making Infographic An infographic with key considerations for RWD quality has been developed to assist researchers interested in using RWD for regulatory decision-making. Real World Data
Asthma Therapeutic Area library for Asthma trials. Clinical Content & Reuse
Automation Opportunities in Pharmacovigilance: An Industry Survey (Paper) This paper highlights opportunities and provides an initial starting point for companies considering ICSR process automation. Supplemented by the Interactive ICSR & Automation Technologies Tool (IATT). Intelligent Automation Opportunities in Pharmacovigilance
Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption (Paper) The research included in this paper suggests that while the appetite for eConsent is increasing, industry stakeholders must continue to raise awareness, communicate and collaborate to develop appropriate technological capabilities, regulatory pathways, and operational processes to clear the path for mainstream use of eConsent. eConsent

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Initiative Solution Description Initiative
Black Swan Events and Intelligent Automation for Routine Safety Surveillance This published paper discusses black swan events in the context of pharmacovigilance and the role of machine learning in helping to mitigate such events. The paper explores effective approaches to managing risk of potential black swan events and outlines several strategies to address those risks of potential black swan events during data ingestion. Here is a video discussing the paper in detail. Intelligent Automation Opportunities in Pharmacovigilance
Breast Cancer Therapeutic Area library for Breast Cancer trials. Clinical Content & Reuse

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Initiative Solution Description Initiative
Call to Action: Harmonization of Pharmacovigilance Regulations for Post-Marketing Pregnancy and Breastfeeding Safety Studies Paper The article focuses on post-marketing pregnancy and breastfeeding safety studies, raising awareness of the industry perspective on challenges due to the lack of harmonization and gaps in current PV regulations. It is intended to increase awareness among the industry and health authorities and calls for global legislation harmonization. Interpretation of Pharmacovigilance Guidances & Regulations
CC&R Infographic Powerpoint and PDF representation depicting focus areas of the CC&R Initiative (Harmonized Model Content, Reuse Capabilities, Clinical Template Suite) and the connectivity of related components and principles. Clinical Content & Reuse
Clinical Data Reuse Assessment Form A template for assessing the reuse of data for a possible research activity. Interpretation of Clinical Guidances & Regulations
Clinical Data Reuse Glossary A glossary, which provides definitions relevant to key terms within the framework. Interpretation of Clinical Guidances & Regulations
Clinical Data Reuse Overview Video A video on the key aspects of the framework, including principles for reuse of clinical data, a glossary, use cases and a best practice process. Interpretation of Clinical Guidances & Regulations
Clinical Data Reuse Step-By-Step Best Practice Process A quick overview of a process, which companies can use when considering a data reuse project, containing a table aligning the stages and steps with the principles outlined in the framework. Interpretation of Clinical Guidances & Regulations
Clinical Data Sharing: A Proposed Methodology to Enable Data Privacy While Improving Secondary Use This proposed methodology addresses issues related to privacy regulations and compliance in connection with secondary reuse of clinical trial data. Privacy Methodology for Data Sharing
Clinical Data Sharing: Transparency Checklist Template The Transparency checklist should be included with each study package shared, to provide information on the data protection methods applied to facilitate use of the data. Privacy Methodology for Data Sharing
Clinical Data Standards Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes. Clinical Data Standards
Clinical Knowledge Management Assessment Tool A set of survey questions on CKM. Allows organizations to assess their initial current state of Clinical KM awareness and needs; intended for organizations at early stages in their KM journeys (baseline). Quality Management System
Clinical Knowledge Management Detailed Overview More detailed slide deck than the overview slides listed above. Explores in more detail the intricacies of the CKM concepts explained in the CKM manuscript. Quality Management System
Clinical Knowledge Management High-Level Overview Overview slides that introduce CKM to senior leadership. Succinctly describes CKM and its potential value, allowing for simple conversation on the topic. Quality Management System
Clinical Knowledge Management Reference and Tool Guide Comprehensive list of suggested resources/tools. Supports the voluntary implementation of KM programming. Quality Management System
Clinical Knowledge Management Scenarios Anonymized scenarios/examples in which a CKM could have, or did help, to address specific issues. Providers readers with examples of the value (realized and potential) of CKM. Quality Management System
Clinical Research Awareness: A Proposed Study Design to Assess the Role of Shared Decision Making in the Consideration of Clinical Trial Participation This paper aims to enable researchers to assess the value and measures the impact of Shared Decision Making (SDM) on patient and HCP satisfaction. Clinical Research Awareness
Clinical Template Suite Implementation Support Resource (ISR) Master slide deck combining 21 legacy assets to support the implementation of the CTS within an organization. Clinical Content & Reuse
Clinical Template Suite Implementation Toolkit A set of tools to enable assessment and adoption of the Clinical Template Suite. Clinical Content & Reuse
Clinical Template Suite Mapping Worksheet Single mapping worksheet and accompanying instructions for comparing any of the CTS templates to a company template. The link is also provided within the Implementation Support Resource in addition to the website. Clinical Content & Reuse
Clinical Template Suite Style Guide Tabular listing of the type of text, description, and styles utilized within the CTS (CPT, CSR, SAP). Clinical Content & Reuse
Clinical Trial Communication Opportunities Infographic Infographic highlights potential communication opportunities to provide the information patients are looking for along the clinical trial continuum. Clinical Research Access & Information Exchange
Clinical Trial Registration Tool A tool individual clinical trial sponsors can use to proactively evaluate the quality of the clinical trial registration data they submit to government-owned registries. Download to take a closer look at to leverage the Clinical Trial Registration Tool. Clinical Research Access & Information Exchange
Clinical Trial Registry of the Future eBook eBook illustrates thestep-by-step user experience and functionsfeatured on each screen in the ClinicalTrial Registry of the Future proof of concept. Clinical Research Access & Information Exchange
Clinical Trials in 2031 and Beyond Report that utilizes a scenario planning exercise to explore the potential drivers influencing the future of clinical trials. Includes four potential future scenarios of clinical trials and outlined the characteristics of each scenario. Modernizing Clinical Trial Conduct
Collaboration Hub Sponsor Toolkit: Portfolio and Program-Level Considerations for Diversity, Equity, and Inclusion of Participants in Clinical Trials (DEICT) A toolkit designed to support sponsor efforts to leverage key portfolio and program/compound level diversity considerations to facilitate meaningful* inclusion of diverse patient populations in the drug development lifecycle. The inclusion of diverse patient populations in clinical trials is of increasing importance to health authorities including the US Food and Drug Administration and more inclusive trial practices are being strongly encouraged. To address this call to action, this toolkit includes guidance for sponsors across sponsors’ portfolios and compound development.  * Integrated design and operational strategies that support the generation of robust actionable data for diverse patient populations Diversity of Participants in Clinical Trials
Common Clinical Study Report (CSR) – Basic Word Edition Document template with common structure and proposed model content, aligned with ICH E3 and CORE. Integrates with CPT and SAP templates. Clinical Content & Reuse
Common Protocol Template (CPT) – Basic Word Edition Document template with a harmonized and streamlined approach to the format and content of clinical trial protocols. Includes common structure, proposed model content and participant and TA libraries. Clinical Content & Reuse
Common Serious Adverse Event Fields Overview & Outputs A set of slides detailing the initiative’s background, its methodology for creating a core list of Common SAE Fields, and overview of the initiative’s outputs. Common Serious Adverse Events (SAE) Fields
Common Statistical Analysis Plan (SAP) – Basic Word Edition Document template with common structure and proposed model content, aligned with ICH E9. Integrates with CPT and CSR templates. Clinical Content & Reuse
Communication Templates Overview Overview presentation that summarizes the template objectives, considerations for use, methodology of development, and feedback received from patients, sites, and IRBs. Clinical Research Access & Information Exchange
Community Engagement for Sites Webinar, Read Along & Template Letter The objective of the this content is to provide sites used by sponsor organizations with tools to recruit minority populations by engaging with local community organizations. Content provided is intended for staff at sites, and therefore should be shared with anyone responsible for engaging with or supporting sites, including Site Managers, Site Monitors and Site Liaisons. Diversity of Participants in Clinical Trials
Comparator Network Web-based ordering system to execute comparator product transactions. Must be a Member of TransCelerate BioPharma. Comparator Network
Comparison Versions (zip file) Contains comparison versions for core templates and any updated library files. Clinical Content & Reuse
Conceptual Proactive Triage Thresholds for Potential Issues That Matter Video This tool includes slides with a narrative voiceover provided by an expert from the QMS Initiative. This module covers points to consider, along with scenarios, to assist sponsors in establishing an issue triage mechanism that assesses the impact of an issue. Enables users to differentiate between Issues That Matter, which are managed through a robust CAPA process, and issues that will be managed according to an organization’s tolerance to risk (thresholds); provides guidance on determining triage thresholds. Quality Management System
COPD Therapeutic Area library for COPD trials. Clinical Content & Reuse
CPT Implementation Tools A set of tools to enable assessment and adoption of the Common Protocol Template. Clinical Content & Reuse
Creating or Customizing an eTemplate Library Reference document and accompanying template for editing or creating a custome eTemplate compatible participant type or therapeutic area library. Clinical Content & Reuse
CSR Considerations for Studies Disrupted by the COVID-19 Pandemic Identified the important topics for clinical researchers and research sponsors to consider as they adapt their studies and clinical study reports to disruptions caused by COVID-19. Clinical Content & Reuse
CSR Implementation Tools A set of tools to enable assessment and adoption of the CSR. Clinical Content & Reuse
CSR Mapped to ICH E3 and CORE Guidance Spreadsheet mapping of the common CSR template to ICH E3 and CORE requirements and rationale. Clinical Content & Reuse
Cultural Competency Webinar & Read Along Provides information to sponsor company study teams to help raise awareness at the site level of the benefits of cultural competency and provide guidance on how and when to use available resources. Diversity of Participants in Clinical Trials
CV-Safety Therapeutic Area library for CV Safety trials. Clinical Content & Reuse

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Initiative Solution Description Initiative
Data Mapping (FHIR-SDTM) for Labs, AEs, and SOA Mapping of data elements between the HL7 FHIR standard and CDISC SDTM standard for labs, AEs, and SOA to enable interoperability between clinical data standards and healthcare data standards. Output was provided to HL7 to put through public comment. eSource
DataCelerate® A global technology platform that allows for multiple de-identified research and development data types to be voluntarily submitted, uploaded, converted, harmonized, and downloaded through an access-controlled, secured environment. Serving as a data lake solution, the robust development and scalable design of DataCelerate features a flexible single sign-on platform with an automated user interface to quickly develop translational insights across the research and development (R&D) continuum. DataCelerate®
Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Parts 1 & 2 (Papers) These papers provide a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. Describes the initial implementation steps designed to learn what organizational capabilities are necessary. Risk Based Monitoring
Definition of Primary and Secondary Use of Clinical Data Examples of potential primary and secondary uses of clinical data within the pharmaceutical industry. Interpretation of Clinical Guidances & Regulations
Demystifying Quality Tolerance Limits Webinar This webinar reviews guidance and considerations for QTL implementation in Clinical Development through highlights from the TransCelerate Quality Tolerance Limits Framework, including but not limited to a proposed definition of the term “QTL,” process map/steps, and examples of QTL parameters. Interpretation of Clinical Guidances & Regulations
Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations (Paper) Focuses on detecting data quality issues, irrespective of origin or motive. Risk Based Monitoring
Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations Paper To advance industry use of Novel Digital Endpoints (NDEs) to support drug development, this paper outlines a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA). Patient Technology
Development and Implementation of a Pharma-Collaborative Large Historical Control Database Provides guidance on the potential application of a large historical PSoC database and provides examples for the possible implementation of historic data in seven specific use cases. Historical Trial Data Sharing
DIA 2020: If You Build it, Will They Come? What’s Really Needed to Transform Information Flow in Clinical Development? Powerpoint slides presented at annual DIA meeting in June 2020. Example of "current communication" content we will include annually with the release. Clinical Content & Reuse
Diabetes Therapeutic Area library for Diabetes trials. Clinical Content & Reuse
Diabetic Kidney Disease Therapeutic Area library for Diabetic Kidney Disease trials. Clinical Content & Reuse
Digital Data Flow Benefits Video A video describing the benefits of the Digital Data Flow Initiative. Digital Data Flow
Digital Data Flow Common Protocol Template Command Line Interface Proof-of-Concept Utility Tool The DDF Initiative has developed, in collaboration with Arborsys, a proof-of-concept utility tool to show how USDM can be mapped to the TransCelerate CC&R Common Protocol Template format, and to additionally demonstrate the automated population of an eCPT Word document by loading a USDM file directly from the SDR. Digital Data Flow
Digital Data Flow Common Protocol Template-Common Line Interface Tool A proof-of-concept utility tool to show how CDISC's Unified Study Definitions Model (USDM) can be mapped to the TransCelerate CPT format, and additionally demonstrate the automated population of an eCPT Word document by loading a USDM file directly from the SDR.     Digital Data Flow
Digital Data Flow Communications Materials Materials (DDF Overview, FAQs, CDISC Unified Study Definitions Model, GitHub page, and “What is Digital Data Flow?” video) to provide relevant stakeholders with a clear understanding of DDF's value proposition. Digital Data Flow
Digital Data Flow Sponsor Company Transformation Tools Set of communications materials, change management journey, organizational assessment, and key personas that can help enable digital data flow within sponsor organizations. Digital Data Flow
Digital Data Flow Study Definitions Repository Reference Implementation Overview Video A video describing the Study Definitions Repository Reference Implementation MVP. Digital Data Flow
Digital Data Flow Technology Architecture Scenarios Tool A set of possible scenarios for the technical implementation of the Unified Study Definitions Model, provided to help companies think about how they might use the USDM and DDF concepts to better enable end-to-end data flow.  Digital Data Flow
Digital Data Flow Unified Study Definitions Model Video A video describing an overview of CDISC's Unified Study Definitions Model for digital data flow. Digital Data Flow
Digital Health Glossary A compilation of definitions provided by regulators, industry consortia, and other stakeholders for common vocabulary and synonyms, which will aid in understanding terms directly related to digital health to increase clarity, communication, and better decision-making. Interpretation of Pharmacovigilance Guidances & Regulations
Digital Health Reference Resource Library A catalog of identified regulations and guidelines to aid in understanding what is driving digital health in selected countries. Interpretation of Pharmacovigilance Guidances & Regulations
Diversification Practices Guidance for sponsors and clinical trial sites regarding better practices and processes for minority recruitment. Diversity of Participants in Clinical Trials
Diversity by Design: Proactive Approaches to Facilitate Industry-Wide Diversification of Clinical Trial Participants Webinar Presentation slides can be viewed here. The webinar focuses on: An overview of the importance of improving the representation of diverse patient populations in clinical trials Key considerations to accelerate industry-wide diversification of clinical trial participants Available tools to action the key considerations to prospectively evolve trial design, enrollment, and participation strategy How to navigate the newly redesigned Diversity of Participants in Clinical Trials initiative website Diversity of Participants in Clinical Trials
Diversity Community-Based Site
Engagement and Capacity Building
Provides an aggregated collection of insights and perspectives from the attending organizations of a June 9 Roundtable Event, regarding considerations that sponsors, sites, and others have taken to enhance engagement and capacity building for community-based sites.​ Diversity of Participants in Clinical Trials
Diversity for Awareness for Sites & Sponsors Webinar & Read Alongs Provides sponsor companies with information and tools to help raise awareness of the need to achieve clinical trial populations which are representative of the target indication. Materials also provide tools and guidance which may be used by sites to increase clinical trial participation of minority patients. Diversity of Participants in Clinical Trials
Diversity of Participants in Clinical Trials Reference Table & Landscape of Available Solutions Descriptions and links to publicly available resources for Patients, Sponsors, and Sites/HCPs. Also, includes a visual landscape of the resources described and linked in the reference tables. The landscape also indicates resources that serve overlapping stakeholder communities. Diversity of Participants in Clinical Trials

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Initiative Solution Description Initiative
eConsent Business Case A customizable PowerPoint template available for Member Companies to support the creation of a business case for the implementation/adoption of eConsent. eConsent
eConsent Implementation Guidance Document outlining comprehensive, practical eConsent implementation approaches and considerations for sponsors and other interested parties. Developed through a collaboration with patients and sites, health authorities (HAs) and institutional review boards (IRBs)/independent ethics committees (IECs), and clinical research organizations (CROs). eConsent
eConsent Patient Advisory Summary Report Summary report describing the perspectives of an eConsent patient advisory board (PAB) commissioned through the Center for Information and Study on Clinical Research Participation (CISCRP). eConsent
eConsent Site Facing Tools Tools designed to be used by sites/sponsors when implementing eConsent, developed through a collaboration with an eConsent site advocacy group (SAG) commissioned through the Society for Clinical Research Sites (SCRS). eConsent
eConsent: Considerations for Health Literacy Document provides guidance and considerations to improve the comprehension and readability of eConsent material. eConsent
eConsent: Considerations for Vulnerable Populations Document provides guidance and considerations for the use of eConsent with vulnerable populations. eConsent
eConsent: Emerging Trends and Future Considerations Document provides perspectives on the potential future utility of eConsent and its potential integration with other eClinical technologies/platforms. eConsent
eLabels Business Case Template A template which can be used in support of developing an eLabels business case within an organization. eLabels
eLabels Concept Materials Guidance on what factors to consider when designing a universal eLabel. eLabels
eLabels Design and Delivery Toolkit Implementation toolkit available on the TransCelerate external website providing guidance on voluntary implementation and to assist in Healthcare Authority engagements. Includes design, regulatory, technical and stakeholder considerations. eLabels
eLabels Frequently Asked Questions A document answering common questions around eLabels. eLabels
eLabels Glossary of Terms An index defining the key terms used within the eLabels toolkit and related resources. eLabels
eLabels Implementation Planning Tools A series of guidance documents and planning tools to help support voluntary implementation planning for eLabels solutions. eLabels
eLabels Pain Points vs. Benefits A handout detailing stakeholders’ issues with the current labeling process and how adopting eLabels will allow you to address each problem. eLabels
eLabels Roles & Resources Template A template that can be used to develop necessary roles and resources needed for eLabels implementation and support. eLabels
eLabels Systems Inventory Template A template that can be used to assess all systems that may be impacted by an eLabels implementation. eLabels
eLabels Technology Approach Guidance on what factors to consider before implementing eLabels technology. eLabels
Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline DIA TIRS publication which describes the vision and outline for a Clinical QMS conceptual framework. Provides an initial outline of a conceptual framework for a Clinical QMS, and how it can help organizations achieve clinical quality goals linked to their broader strategic goals. Explains how a Clinical QMS alleviates issues related to trial inefficiencies. Quality Management System
eSource Informatics Continuum The objective of the eSource Informatics Continuum is to help study sites determine their readiness for eSource implementation, by identifying their location on the continuum and pathway to increase interoperability. The continuum includes a diagram that shows different varying degrees of interoperability based on clinical informatics, starting with ‘traditional’ data collection, i.e., using paper medical records and paper case report forms (CRFs), and ending with ‘innovative’ data collection, which includes full interoperability and integration between clinical care and clinical research. eSource
eSource Site Capability Questionnaire Used by sponsors to help capture the site’s use of technology during the site qualification process. Intent is to facilitate the reduction of any administrative burden on sites by collecting information in a consistent manner. eSource
eTemplates (eCPT, eCSR, eSAP) The eTemplates are Word templates with technical functions to enable automation and clinical content re-use to downstream documents, processes, and registries. Clinical Content & Reuse
eTemplates (zip file) Zip file containing CTS Add-ins, eCPT, eSAP, eCSR Core templates, eTemplates installation instructions, & CTS Prerequisite Analyzer application. Clinical Content & Reuse
eTemplates Guidance for Use Support document for end users that outlines all functionality related to the eTemplates and Add-ins. Clinical Content & Reuse
eTemplates Variable ReUse Map Spreadsheet listing of the structured content variables established and where they are used across the eTemplates(eCPT, eCSR, eSAP). Clinical Content & Reuse
Evaluating a Clinical Trial Video Narrated video highlights information and features proposed in the Clinical Trial Registry of the Future concept aimed at providing patients a more robust experience when evaluating or considering a clinical trial. Clinical Research Access & Information Exchange
Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials (Paper) Assesses the value of SDV in clinical trial monitoring via a literature review, a retrospective analysis of data from clinical trials, and an assessment of major and critical findings from TransCelerate member company internal audits. Risk Based Monitoring
Examining Possibilities for a Consistent Procedures Library to Modernize Clinical Trials: A TransCelerate Point of View 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 toward a digitized protocol have been summarized in a whitepaper. Clinical Content & Reuse
Exploring the Impact of Shared Decision Making in Clinical Trial Consideration Paper This paper explores shared decision-making in patient-provider conversations with the aim to enable patients to better understand clinical trials as a care option. Clinical Research Awareness
Exploring the Value in Implementing a Clinical Quality Management System (cQMS) Framework An infographic that details success stories around five elements of thecQMS framework that TransCelerate's Member Companies have implemented, including process management, risk management, partnering, issue management, and management review. Quality Management System

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Initiative Solution Description Initiative
FAQs Excel spreadsheet with list of frequently asked questions and answers that are classified by template type (CPT, CSR, SAP) and topic. Clinical Content & Reuse
FDA Diversity Plan Early Insights & Considerations Provides an aggregated collection of insights and considerations gathered from Member Company interviews that help to inform operational strategies and identify how practical implementation of U.S. Food and Drug Administration (FDA) Diversity Plans may progress as industry thinking matures in this area.  Diversity of Participants in Clinical Trials
FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide & Webinar An Implementation Guide to aide pharmaceutical manufacturers‘ understanding of ambiguous areas of the PMSR for Combination Products Draft Guidance for Industry and FDA Staff. In addition, a webinar presentation is included where TransCelerate team members provide an overview of the FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide. Interpretation of Pharmacovigilance Guidances & Regulations
Forms for Investigator Sites A series of harmonized forms and templates leveraged across sponsors and used by investigator sites for critical clinical trial activities. Site Qualification and Training
Four Reasons Why a Clinical QMS Is Tailor-Made for Clinical Development Infographic Provides background on QMS in the context of fit for product manufacturing; conveys why a manufacturing (GMP) and a Clinical QMS must differ. Quality Management System
Fundamentals of a cQMS Guides users in understanding the value proposition and potential applications of the QMS conceptual framework elements. Quality Management System

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Initiative Solution Description Initiative
GDPR Data Reuse Glossary A glossary which provides definitions relevant to key terms within the framework. Interpretation of Clinical Guidances & Regulations
GDPR Data Reuse Step-by-Step Best Practice Process A quick overview of a process, which companies can use when considering a data reuse project, containing a table aligning the stages and steps with the principles outlined in the framework. Interpretation of Clinical Guidances & Regulations
Global Pharmacovigilance Regulations: Call for Re-Harmonization Letter to the Editor of Journal of Clinical Trials (Paper) A letter to the editor of Clinical Trials, noting a trend towards divergence of pharmacovigilance regulations. This letter is a call for re-harmonization to raise awareness of the issue and call for all stakeholders, in particular Health Authorities, to take efforts to re-harmonize. Interpretation of Pharmacovigilance Guidances & Regulations
Good Clinical Practice Training Mutual Recognition Program GCP Training Providers can self-attest to meeting minimum criteria based on ICH GCP guidelines which facilitates reduction in duplicative training for Investigator Sites by allowing potential mutual recognition across sponsor companies. Site Qualification and Training
Gratitude Toolkit Implementation Insights User Guide  A set of deliverables that sponsors, with their site partners, can leverage to acknowledge and show appreciation to clinical trial participants. The GRAT streamlines options and tactics, providing a compilation of deliverables for study teams in healthcare for ease of implementation, with reduced friction and time. Patient Experience

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Initiative Solution Description Initiative
Healthy Volunteer Participant Type library for Healthy Volunteer trials. Clinical Content & Reuse
Historical Trial Data Sharing (Controls) DataCelerate® Placebo/Standard of Care's new data home that will enable better searching and visualization of data shared among participating Member Companies. Historical Trial Data Sharing
HL7 FHIR® Implementation Guide The Mapping and Standards team partnered with HL7’s Biomedical Research and Regulation (BR&R) Working Group to deliver an FHIR Implementation Guide that contains the mapping process deliverables and provides requirements to Sites who seek to share data via FHIR. The deliverables have been published on the HL7 web site: http://hl7.org/fhir/uv/cdisc-lab/2019Sep/. eSource

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Initiative Solution Description Initiative
ICH E8 Case Studies A collection of three sponsor company case studies to demonstrate ICH E8 (R1) concepts in action. Interpretation of Clinical Guidances & Regulations
ICH E8 Culture & Engagement Resource Pack A compilation of links to resources intended to provide informational and educational materials for the clinical development ecosystem to support the understanding, implementation, and operationalization of these newly introduced concepts in ICH E8 (R1).​ Interpretation of Clinical Guidances & Regulations
ICH E8 Landscape Assessment The Landscape Assessment benchmarks information gathered from a survey of sponsor companies to help understand the progress and challenges of ICH E8 (R1) implementation. Interpretation of Clinical Guidances & Regulations
ICH E8: Resources for the Application of Critical to Quality Factors Considerations and information to help with the interpretation and application of Critical to Quality Factors throughout clinical studies. ​ Interpretation of Clinical Guidances & Regulations
ICH E8: Stakeholder Engagement for Clinical Development A tool to help study sponsors manage quality by facilitating the implementation of ICH E8’s principles regarding stakeholder engagement throughout the clinical development lifecycle. Interpretation of Clinical Guidances & Regulations
Identifying the Value of Information Data Sources to Improve Patient Safety Infographic This infographic overviews the main study findings and data from two papers published by TransCelerate’s VSIDS’s team. Value of Safety Information Data Sources
Illustrative Cycle Time Improvement: Conventional Model vs. eLabels Model A handout illustrating the cycle time improvement of the eLabels model vs. the conventional model. eLabels
Improving Information Exchange with Clinical Trial Participants: A Proposal for Industry This paper reviews data collected by TransCelerate around information exchange in clinical trials, including insights from patients, sponsors, sites and healthcare professionals, and provides potential opportunities to improve participants’ experience with clinical trials through greater transparency. Clinical Research Access & Information Exchange
Improving Investigative Site Contact Options on Clinical Trial Registries: Making It Easier for Patients to Find Clinical Trials (Paper) Paper offers guidance on a practical first step toward closing the gap between individuals willing to participate in clinical trials and the enrolling investigative sites for those trials, by making it easier to contact site locations through clinical trial registry listings. Clinical Research Access & Information Exchange
Improving Investigator Site Contacts Provides guidance on steps towards closing the gap between individuals willing to participate in clinical trials and the enrolling investigative sites for those trials, by making it easier to contact site locations through clinical trial registry listings. Clinical Research Access & Information Exchange
Improving Safety & Efficacy of Medicines for Pregnant & Breastfeeding People Infographic An infographic introducing why medication use in pregnant people is so important; the right of pregnant people and their partners to have access to medicines with evidence-based information on the safety and efficacy of their use during pregnancy & breastfeeding; and how TransCelerate is focusing on raising awareness of current regulatory requirements, the industry perspective on challenges, and considerations when developing medicinal products to be used for maternal health.  Interpretation of Pharmacovigilance Guidances & Regulations
Improving the Value of Public Clinical Trial Registries to Patients: A Perspective and Call to Action Proposal illustrates the challenges patients, their family members and healthcare professionals face when interacting and understanding the vast clinical research information available through government-sponsored registries, and provides a perspective, illustrative proof of concept, and call to action to advance multi-stakeholder collaboration on potential improvements to clinical trial registries. Clinical Research Access & Information Exchange
Individual Case Safety Report Replication: An Analysis of Case Reporting Transmission Networks This Drug Safety article reports on an analysis that quantifies the amount of Individual Case Safety Report (ICSR) replication within the pharmacovigilance ecosystem. It is the first quantification of the phenomenon of ICSR replication across Health Authority and marketing authorization holder safety databases. Intelligent Automation Opportunities in Pharmacovigilance
Individual Participant Data Return (iPDR) Package Provides general considerations to enable data return to clinical study participants and includes three components – a Socialization Presentation, Considerations Guide, and Template.  Participant Data Return
Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient Safety (Paper) Provides perspectives regarding hierarchy of value for collecting, processing, analyzing and reporting of adverse event information. Value of Safety Information Data Sources
Industry Experience and Perspective on Clinical Trial Safety Reporting to the FDA (Paper) In this publication, TransCelerate member companies summarize their experience in operationalizing FDA’s clinical trial monitoring and reporting requirements with a key focus on FDA’s 2015 Safety Assessment Guidance (draft). Interpretation of Pharmacovigilance Guidances & Regulations
Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance This published paper is a follow-up to a previous Individual Case Study Report paper which combines data from 2019-2021​. The paper describes major trends​, interprets and suggests why these trends exist​, includes an updated ICSR Heat Map​, and includes an update for case studies from the Foundation Paper Table 2. Here is a video discussing the paper in detail. Intelligent Automation Opportunities in Pharmacovigilance
Industry Perspective on the CTFG Q&A document – Reference Safety Information (Nov 2017) (Paper) Publication which summarizes team’s interpretation of ambiguous portions of Q&A and shares survey findings on implementation challenges and approaches. Interpretation of Pharmacovigilance Guidances & Regulations
Informational Programs for Investigator Sites A series of videos that describe the basic components of clinical research in accordance with the ICH Good Clinical Practice. Now owned by SCRS. Site Qualification and Training
Informed Consent Short Form Webinar, Read Along & Template Provides sponsor companies with tools to increase clinical trial participation for patients with limited English proficiency and low health literacy/numeracy. Diversity of Participants in Clinical Trials
Installation Instructions Instructions for installing the Clinical Template Suite add-ins and eTemplates as well as how to use the Prerequisite Analyzer to evaluate system requirements. Clinical Content & Reuse
Integrated Quality and Risk Management Plan Framework The IQRMP provides a tailored and integrated plan for a clinical trial that will include the clinical and medical risks identified at the program leveland assists in shared responsibility across all functions involved in collecting, analyzing and reporting clinical trial data. Risk Based Monitoring
Interactive ICSR & Automation Technologies Tool (IATT) An interactive tool that highlights opportunities and benefits for automation in the ICSR process and provides a visual representation of those opportunities. Intelligent Automation Opportunities in Pharmacovigilance
Interactive ICSR & Automation Technologies Tool Demo Video A video describing how the Interactive ICSR and Automation Technologies Tool (IATT) was developed and a demonstration of how it can be used. Intelligent Automation Opportunities in Pharmacovigilance
Introduction to TransCelerate BioPharma Inc. Powerpoint slides describing Transcelerate as a non-profit organization, the Member Companies involved, the collaborative reach and mission, and an overview of the Clinical Content & Reuse Initiative. Clinical Content & Reuse
Introduction to TransCelerate eTemplates Overview narrated video for the CTS eTemplates that is the first video in the TransCelerate eTemplates YouTube playlist. Clinical Content & Reuse
Introductory Letter to Investigative Sites Provides a sample letter which may be used to communicate with investigators and site personnel about the plans of providing layperson summaries. Clinical Research Access & Information Exchange
Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase® FDA Adverse Event Reporting System (FAERS) and VigiBase® are two established databases for safety monitoring of medicinal products, recently complemented with the EudraVigilance Data Analysis System (EVDAS). Signals of disproportionate reporting (SDRs) can characterize the reporting profile of a drug, accounting for the distribution of all drugs and all events in the database. This study aims to quantify the redundancy among the three databases when characterized by two disproportionality-based analyses (DPA). Advancing Safety Analytics
Investigator Education Material for Layperson Summary Provides guidance to consider when developing an educational slide set on the overview of layperson summaries, potential content for the layperson summary, and investigator involvement. Clinical Research Access & Information Exchange
Investigator Registry Alongside the Shared Investigator Platform, a combined solution providing accelerated identification of qualified investigators, facilitates site/sponsor interactions, and reduces administrative burden of clinical trial operations. Investigator Registry
Issues Related to Non-CRF Data Practices (Paper) Practices and procedures for the collection and retention of non-CRF data are crucial to maintaining data accuracy and integrity. To guide the development of such practices and procedures, this paper outlines certain high-level best practices related to handling and managing non-CRF data.​ eSource

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Initiative Solution Description Initiative
Key Risk Management Changes in Good Clinical Practice [ICH E6(R3)] Infographic An infographic that highlights key changes to the risk management elements within Good Clinical Practice Version 2 and 3. Co-developed with ACRO, this infographic aims to allow industry to easily identify the impact to their process and how to react for efficient ICH E6 (R3) implementation. Interpretation of Clinical Guidances & Regulations

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Initiative Solution Description Initiative
Layperson Summaries Provides general priniciples helping sponsors prepare and distribute layperson summaries to the general public and study participants to implement the obligations of the European Union Clinical Trial Regulation No. 536/2014. Clinical Research Access & Information Exchange
Layperson Summaries Roadshow Slide Set Provides a sample communication deck which describes the vision and overview of the layperson summary program. Clinical Research Access & Information Exchange
Leveraging the Value of CDISC SEND Datasets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals (Paper) A peer-reviewed paper which highlights the potential of SEND datasets for cross-study analysis and proposes solutions to address the challenges of doing so currently. SEND Implementation for Cross-Study Analysis

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Initiative Solution Description Initiative
Marketing Partner Audit Conduct Offers options and considerations on different audit approaches which can help generate efficiency in the marketing partner audit program.    Pharmacovigilance Agreements Optimization
Marketing Partner Audit Responses & Follow-Up Provides some points to consider before starting audit response development. The tools deal with the end of the audit lifecycle, specifically the audit response process and CAPA follow up.  Pharmacovigilance Agreements Optimization
Marketing Partner Audit Risk Prioritization This document outlines considerations for a risk-based approach to prioritizing and scheduling Marketing Partner audits.  Pharmacovigilance Agreements Optimization
Marketing Partner Audit Risk Prioritization Scorecard An example scorecard to help companies develop a risk-based score derived from company-selected and analyzed criteria.  Pharmacovigilance Agreements Optimization
Marketing Partner Audit Scheduling & Scoping Provides some points to consider when scheduling and scoping business partner audits. Note that this solution deals with the preparation phase of the audit lifecycle and helps design the appropriate scope for pharmacovigilance audits.  Pharmacovigilance Agreements Optimization
Measuring the Impact of Risk Based Monitoring (Paper) Provides an overview of the TransCelerate RBM initiative’s original vision for specific metrics with the potential to effectively measure the value and impact of RBM from multiple perspectives and an analysis of how those original, suggested metrics have been put into realworld practice. Risk Based Monitoring
Member Company eConsent Asset Value and Impact Case Study Case study with empirical data to illustrate value and impact of eConsent assets for Member Companies, informed by aggregated Member company survey data regarding the usage and value of eConsent assets. eConsent
Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and Opportunities (Paper) As part of the continuing dialogue with Regulators, this paper aims to address the data selection methodology challenges, particularly when Placebo/Standard of Care is used to augment or substitute clinical control arms. Historical Trial Data Sharing
Modern Solution Adoption Maturity Survey Results Aggregated survey findings from TransCelerate's 20 Member Companies to better understand the collective experience of deploying modern solutions. Modernizing Clinical Trial Conduct
Modernization of Statistical Analytics (MSA) Framework This Framework is based upon a methodology that establishes the principles of accuracy, reproducibility, and traceability for a modern analytical software environment to demonstrate that the results it generates is reliable. A set of best practices and guiding principles is also provided to support the Framework’s implementation across industry sponsors and other stakeholders. Additional resources include an infographic and a case for adoption. Modernization of Statistical Analytics
Modernization of Statistical Analytics Case for Adoption A presentation to support the socialization and usage of the framework concepts. This deck aims to help organizations better understand and utilize the MSA Framework as they explore the use of nontraditional analytical software in clinical research. Modernization of Statistical Analytics
Modernization of Statistical Analytics Case Study: Environment for Regulatory Submission A video and presentation that encompasses a multi-server computational environment that contains two different types of open-source installations – usual installations for exploratory and general work and frozen installations for submission-related work. Modernization of Statistical Analytics
Modernization of Statistical Analytics Case Study: Group Sequential Design A video and presentation encompassing a study design for group sequential studies to expand and enable the universe of "increasingly compliant" tools with increasing capabilities. Modernization of Statistical Analytics
Modernization of Statistical Analytics Case Study: Implementation & Validation Concept A video and presentation explaining digital transformation requirements for integrating reports into a standard reporting system to create transparency. Modernization of Statistical Analytics
Modernization of Statistical Analytics Case Study: Testing/Verification A video and presentation offering guidance on providing a secure and reliable environment for both exploratory and submission-related analyses using open-source products. Modernization of Statistical Analytics
Modernization of Statistical Analytics Infographic Provides a visual overview of the MSA Framework including key methodologies, concepts, and impact areas for a broader understanding of the Framework paper. Modernization of Statistical Analytics
Modernize Clinical Trials by Enabling a Digital Workflow Webinar This March 2022 webinar shows the progress of the DDF Initiative and features a panel discussion on digital data flow from industry peers. Digital Data Flow
Modernizing Clinical Trial Conduct Process Frameworks Outlines various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected modern solutions. Modernizing Clinical Trial Conduct
Modernizing Clinical Trial Conduct Workshop Findings TransCelerate and the Association for Clinical Research Organizations’ (ACRO) CRO Forum conducted a collaborative workshop to explore root cause challenges and enablers of success for the use of modern methodologies in clinical research; topics include telemedicine, direct to patient shipping, home health visits, and local lab usage. Modernizing Clinical Trial Conduct

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Initiative Solution Description Initiative
Negotiating Your Way through the Vigilance Agreement Maze-Is There a Better Way? Paper A peer-reviewed paper published in Therapeutic Innovation & Regulatory Science (TIRS). The article can be leveraged to find simplification and efficiencies to optimize the process of developing contractual agreements for pharmacovigilance. Pharmacovigilance Agreements Optimization
Nonclinical Common Report Template A nonclinical report template as a companion to the currently available V1.0 Nonclinical Common Protocol Template for the purpose of supporting consistency and efficiencies in the report generation process and reduce the burden on sites, CROs, and sponsors. Common Templates for Nonclinical Studies
Nonclinical Protocol Template Mapping Tool & Instructions An optional resource to assist an organization in assessing impact and facilitating adoption of the nonclinical protocol template. Common Templates for Nonclinical Studies

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Initiative Solution Description Initiative
Offering Choice to Patients: An Overview of the Personalized Clinical Trials Framework Webinar Feedback from clinical trial participants indicates they want options for their clinical trial experience. TransCelerate BioPharma's Personalized Clinical Trials Framework is a set of practical considerations to support the R&D ecosystem (i.e., sponsors, sites, third parties, and other clinical trial stakeholders) to offer options that enable a personalized experience for clinical trial participants across diverse populations. Slides for this webinar can be found here. The webinar focuses on: An overview of the Personalized Clinical Trials Framework, which was developed in partnership with patients, sites, and clinical research organizations Insights into how to incorporate the Personalized Clinical Trials Framework as an integral part of clinical trials within your organization Patient Experience
One Person Closer Campaign The photojournalist campaign aims to show doctors, nurses and other HCPs that they can help facilitate research that advances science and that may benefit their patients.  Clinical Research Awareness
Operational Complexity Assessment Tool An interactive tool that assesses the complexity or lack of complexity of implementing selected modern solutions in a clinical trial, based on several trial aspects that could potentially impact the circumstances of implementation. Modernizing Clinical Trial Conduct
Optimizing the Use of Electronic Data Sources in Clinical Trials, The Landscape, Parts 1 & 2 (Papers) These landscape assessments provide insight into sponsor company eSource activities and the environment affecting eSource adoption based on input from TransCelerate Member Companies, standards organizations, and regulatory authorities. eSource

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Initiative Solution Description Initiative
P-PET Resource Guide The Resource Guide contains a list of sample questions and visual aids. The sample questions in the question bank can be used during development of your patient engagement activity. The questions can be customized to fit your specific engagement activity. Patient Experience
P-PET User Guide A how-to guide for the P-PET. Patient Experience
Participant Data Return Resource Pack A document that provides access to a consolidated set of resources from within the clinical research ecosystem that can assist with returning individual data globally. Participant Data Return
Patient Participant Type library for Patient trials. Clinical Content & Reuse
Patient Advisory Board Patient Advisor Report Template A template to help support engagement discussions with patients and provide feedback to both the study teams and patients. Patient Experience
Patient Advisory Board Pre-Read Sample Template A template to help support engagement discussions with patients and provide feedback to both the study teams and patients. Patient Experience
Patient Advisory Board Sample Template A template to help support engagement discussions with patients and provide feedback to both the study teams and patients. Patient Experience
Patient Advisory Board Satisfaction Survey: Patient Advisor Template A template to help support engagement discussions with patients and provide feedback to both the study teams and patients. Patient Experience
Patient Advisory Board Satisfaction Survey: Study Team Template A template to help support engagement discussions with patients and provide feedback to both the study teams and patients. Patient Experience
Patient Advisory Board Study Team Report Template A template to help support engagement discussions with patients and provide feedback to both the study teams and patients. Patient Experience
Patient Advisory Board Thank You Note: Sample Template A template to help support engagement discussions with patients and provide feedback to both the study teams and patients. Patient Experience
Patient Communication Templates Communication templates that sponsors may use, at their discretion, in order to facilitate exchanging information with clinical trial participants at the outset of clinical trial participation, during the trial and afterwards. Clinical Research Access & Information Exchange
Patient Considerations Toolkit A set of considerations developed with input from patient discussions that when addressed (by sponsors) can result in improved patient experience using patient technology in clinical trials.  Patient Technology
Patient Engagement & Clinical Trial Diversification Webinar & Read Along Provides sponsor companies with guidance on approaches for patient engagement and how they can successfully be used to enable recruitment and retention of minorities within clinical trials. Diversity of Participants in Clinical Trials
Patient Preferences When Searching for Clinical Trials and Adherence of Study Records to ClinicalTrials.gov Guidance in Key Registry Data Fields (Paper) This paper reveals the results of Patient Advisory Board (PAB) Meetings and a global online survey to obtain insight into the information preferences of people using a clinical trial registry in search for a clinical trial. Based on this data, the paper overviews a representative sample of current ClinicalTrial.gov entries and analyzed the extent to which they meet information preferences of people searching for a clinical trial for participation. In addition, we investigated the adherence of current records for brief titles and brief summaries to the guidance provided by ClinicalTrials.gov. Clinical Research Access & Information Exchange
Patient Protocol Engagement Toolkit (P-PET) The Patient Protocol Engagement Toolkit (P-PET) is a comprehensive set of materials that sponsors and other stakeholders can use to engage patients during protocol development. The goal of this engagement is to improve patient experience and reduce patient burden as a study participant. Patient Experience
Patient Protocol Engagement Toolkit Quick Start Video Guides users through key considerations for utilizing the P-PET throughout the patient engagement journey. Includes Japanese subtitles. Patient Experience
Patient Technology Discussion Guide For clinical study teams to consider when planning to implement patient technology. Helps organizations realize the full potential value of their implementation of patient technology by guiding them through the various stakeholder discussions and activities. Patient Technology
Patient Technology Implementation Framework Outlines a possible approach to patient technology implementation to help sponsors develop a holistic approach with patient technology within their own organizations. Shows how companies can use patient technology programs to build towards a unique vision using goals, metrics and important considerations. Patient Technology
Patient Technology Patient Considerations Toolkit Patient Considerations are a list of core questions and considerations to think about during the implementation of PT in clinical trials. It was developed by asking a diverse set of patients what they want sponsors to think about when deciding to implement patient-facing digital technology. Patient Considerations enables study teams to think critically about how their decisions will impact patients. The document covers considerations related to the topics of: Patient BenefitsPatient BurdenPatient CompliancePatient Consent and ComprehensionPatient ExperiencePatient SafetyPatient Willingness to ParticipatePrivacyTechnology MaintenanceTechnology SupportUser Experience Design Patient Technology
Patient Technology Regulatory Landscape Tool (U.S., EU, UK) Collates U.S., UK, and European regulations and guidances related to digital health technologies and their use in clinical trials through December 2022. Helps organizations by providing critical information for use during regulatory strategy planning and Health Authority interaction planning. Patient Technology
Patient Technology Shared Insights Knowledgebase (Paper) A summary of key insights and findings from our collection of 81 cases of patient technology use in clinical trials. Intended to drive people to use the Shared Insights Knowledgebase, as well as highlight best practices and common barriers. Patient Technology
Patient Technology Site Feedback Questionnaire Developed to capture feedback from sites on their experience on using patient technology in clinical trials. Will help to improve dialogue between sites and sponsors and help improve future study design resulting from direct feedback on what works well. Patient Technology
Pediatric Participant Type library for pediatric trials. Clinical Content & Reuse
Persona Toolkit for Clinical Data Managers A set of multiple change resources to help clinical data managers understand and better prepare for how to adapt their roles and responsibilities to new ways of working within an automated and digitalized study lifecycle.  Digital Data Flow
Persona Toolkit for Information Technology Leadership & Technical Expert Roles A set of multiple change resources to help these roles understand the anticipated benefits of the DDF initiative and better prepare for how their role and responsibilities may need to adapt to new ways of working. Digital Data Flow
Persona Toolkit for Protocol Medical Writers A set of multiple change resources to help protocol medical writers understand and better prepare for how to adapt their roles and responsibilities to new ways of working within an automated and digitalized study lifecycle.  Digital Data Flow
Personalized Clinical Trials Framework The interactive Personalized Clinical Trials Framework is a set of practical considerations to support the R&D ecosystem (i.e., sponsors, sites, third parties, and other clinical trial stakeholders) with understanding and evaluating options that enable a more personalized experience for clinical trial participants across diverse populations. The framework provides fourteen potential opportunities to enable personal choice into a clinical trial, and includes considerations to help action the opportunity, potential value and benefits, as well as tools and resources to support implementation. Patient Experience
Perspectives on a cQMS Video Video describing a proposed Clinical QMS framework. Quality Management System
Pharmacovigilance Agreements Glossary A listing of key definitions and synonyms often incorporated into Pharmacovigilance Agreements. Pharmacovigilance Agreements Optimization
Pharmacovigilance Agreements Optimization Glossary Demo Video A video explaining how the Pharmacovigilance Agreements Optimization Glossary can be used and providing background on how the tool was created. Pharmacovigilance Agreements Optimization
Pharmacovigilance Agreements Optimization Interactive Process Map The Process Map solution illustrates the end-to-end PVA lifecycle and offers key considerations throughout the development and maintenance of PVAs. In addition, there are several sets of tools available to address key bottleneck areas within the lifecycle, e.g., negotiation. Pharmacovigilance Agreements Optimization
Pharmacovigilance Agreements Optimization Table of Contents A framework of modules, headings, points to consider, and regulatory references in relation to pharmacovigilance exchange of information and obligations between parties. This TOC was developed in the context of sponsor to sponsor, marketing authorization holder (MAH) to MAH, or sponsor to MAH and vice versa negotiations.  Supplemental Materials were published in July 2023. Pharmacovigilance Agreements Optimization
Pharmacovigilance Agreements-Negotiating Safety Data Exchange Timelines: To Agree or Disagree? That Is the Question This peer-reviewed article is potentially the first benchmarking survey of contracts covering safety data exchange conducted within the pharmaceutical industry (the survey was issued to TransCelerate Member Companies). Data were analyzed to determine the most common types of safety data exchanged, and the associated data exchange timelines, providing information from 378 individual contracts which included data from clinical trials and from post marketing sources. Pharmacovigilance Agreements Optimization
Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That Is The Question Paper A peer-reviewed paper published in Therapeutic Innovation & Regulatory Science. This paper is potentially the first benchmarking survey of contracts covering safety data exchange conducted within the pharmaceutical industry (the survey was issued to TransCelerate Member Companies). Data were analyzed to determine the most common types of safety data exchanged, and the associated data exchange timelines. These data may provide an opportunity for companies to assess how their own timelines compare with others, and to consider whether there are actions they may take that could potentially improve negotiation and procedural efficiency. Pharmacovigilance Agreements Optimization
Placebo/Standard of Care Adoption & Implementation Toolkit A toolkit that describes lessons learned and best practices that can be adopted by participating Member Companies. Historical Trial Data Sharing
Placebo/Standard of Care Data Sharing Initiative Video Discover how TransCelerate's Historical Trial Data Sharing (Controls) Solution is working to improve clinical trial design, better manage study participants, and enhance innovative drug development. Please note, this initiative was formerly known as Placebo and Standard of Care (PSoC). You may see references to PSoC in this video and throughout our website as we continue to update our content. Historical Trial Data Sharing
Placebo/Standard of Care Data Sharing Use Case Studies Presents examples of seven specific use cases for Historical Trial Data Sharing. Historical Trial Data Sharing
Points to Consider Concerning the Use of Medicines in Pregnancy throughout the Product Lifecycle Provides considerations, based on global regulatory requirements, when includingpregnant women in clinical trials through post-marketing studies and is aimed atraising awareness of current regulatory requirements, industry perspective onchallenges, and considerations when developing medicinal products to be used formaternal health. Interpretation of Pharmacovigilance Guidances & Regulations
Points to Consider when Developing a Clinical Study Report (CSR) for a Clinical Trial that Has Been Disrupted Due to Unforeseen Circumstances Issued jointly by TransCelerate and the Association of Clinical Research Organizations, a proposal including learnings from unprecedented interruptions to clinical trials caused by an increasingly diverse set of circumstances and how to address them. Clinical Content & Reuse
Pooling Different Safety Data Sources: Impact of Combining Solicited and Spontaneous Reports on Signal Detection in Pharmacovigilance The volume of adverse events (AEs) collected, analyzed, and reported has been increasing at a rapid rate for over the past 10 years, largely due to the growth of solicited programs. The proportion of various forms of solicited case data has evolved over time, with the main relative volume increase coming from Patient Support Programs. In this study, we sought to examine the impact of the pooling of AE report data from solicited sources with data from spontaneous sources to safety signal detection using disproportionality analysis methods. Value of Safety Information Data Sources
Pre-COVID-19 RBM SDV/SDR Pandemic Practices A report that organizations can use to help benchmark their Risk Based Monitoring activities pre-COVID-19. Modernizing Clinical Trial Conduct
Pregnancy & Breastfeeding Initiatives & Regulatory Landscape Assessment This Landscape Assessment summarizes the current regulatory ecosystem (and relevant initiatives) in selected territories, covering drug safety regulations and guidances addressing pregnancy and breastfeeding from early clinical development to post-marketing settings.  Interpretation of Pharmacovigilance Guidances & Regulations
Pregnancy & Breastfeeding Regulatory Landscape Comparison by Regulation Topic Comparison of in-scope guidances and regulations in the selected territories, against ICH and CIOMS pregnancy and breastfeeding provisions. Interpretation of Pharmacovigilance Guidances & Regulations
Preparing to Engage with Health Authorities on Real World Evidence for Medicines Infographic Provides a visual overview of the Health Authority Engagement Considerations including key methodologies, Health Authority interactions, and illustrative Case Studies for a broader understanding of the Preparing to Engage with Health Authorities on Real World Evidence for Medicine paper. Real World Data
Preparing to Engage with Health Authorities on Real World Evidence for Medicines: A TransCelerate Perspective Provides various options for Sponsors to consider on when to engage with Health Authorities, the type of input, and decisions needed to come to a mutually transparent path forward to include RWE in regulatory decision-making for defined use cases. Real World Data
Prerequisite Analyzer Application deployed with the CTS eTemplates that allows end users to verify if their computer systems meet minimum requirements to install the eTemplates Add-ins. Clinical Content & Reuse
Presentation of Safety Risks Overview Video An introduction and high level overview of what can be found in “A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle”. Interpretation of Pharmacovigilance Guidances & Regulations
Privacy Methodology for Data Sharing Educational Poster (PDF & PowerPoint) The editable educational tool will provide a visual, consistent, succinct, easy-to-understand breakdown for the clinical trial participant outlining how patient privacy is protected by study sponsors. The tool can be edited by a sponsor as necessary to reflect the process it uses. Privacy Methodology for Data Sharing
Privacy Methodology Informational Resource & Video A high-level slide presentation and video providing an overview of the Privacy Methodology Framework and provides information on how and why the privacy methodology was developed and potential uses. Privacy Methodology for Data Sharing
Process Management Framework: Best Practices for Implementation of Processes in Clinical Development Webinar This webinar topic is one of two that will educate and inform interested audience members about the TransCelerate Clinical Quality Management System (CQMS) conceptual framework, as well as the Risk Management and the Processes Frameworks published by TransCelerate.  Quality Management System
Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development (Paper) Describes a framework for effective processes management within clinical development. Assists organizations in understanding the benefits and basic components of process management for clinical development. Includes a suite of change management tools. Quality Management System
Prostate Cancer Participant Type library for pediatric trials. Clinical Content & Reuse
Protocol Deviations Assessment Plan A template to assist in the identification and documentation of protocol-specific "important" deviations. Protocol Deviations
Protocol Deviations Decision Tree This Decision Tree can guide in the identification and classification of important and non-important protocol deviations. Protocol Deviations
Protocol Deviations Map A map of the protocol deviation management process containing processes for both important and non-important deviations. Protocol Deviations
Protocol Deviations Overview Video A video that explains TransCelerate's Protocol Deviations Toolkit and explains potential use scenarios and other examples where the tools can be applied. Protocol Deviations
Protocol Deviations Process Guide A proposed framework describing flexible protocol deviations management approaches, elements for consideration based upon proposed interpretation of the ICH E3 definition for important protocol deviations and other associated PD Guidance with links to the PD Process Map. Protocol Deviations
Protocol Deviations: A Holistic Approach from Defining to Reporting (Paper) This manuscript, published in a peer-reviewed journal, highlights the contents​ of the Protocol Deviation toolkit.  Protocol Deviations
Protocol Template for Repeat-Dose Toxicology Studies With input from key stakeholders, BioCelerate developed a toxicology study protocol template meant for first-in-human enabling, 28-day repeat dose studies. The purpose of a common template is to facilitate efficiencies for CROs, sponsors and others involved in toxicology study execution or review. Includes a suite of tools to aid in adoption. BioCelerate

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Initiative Solution Description Initiative
QMS Issues Management Analysis and Visualization of Trending and Analytics Data Video This tool includes slides with a narrative voiceover provided by an expert from the QMS Initiative. This module explores activities focused on utilizing data (Issues that Matter and Issues from Thresholds) to aid in identifying trends. Categorization into “buckets” to assess tracking and trending of issues differentiated by thresholds. Trending and Analytics tools will include characteristics of tools, visualizations of possible metrics that can be produced, scenarios to show the benefits of what a visualization of tools can provide in terms of insights, and predictions and actionable recommendations. Quality Management System
QMS Issues Management Root Cause Investigation/CAPA Plan This set of tools includes slides with a narrative voiceover provided by an expert from the QMS Initiative. This module outlines methodologies and points to consider in determining when to use Fishbone, Gilbert Tools, Structured Brainstorming Tools, or Process Mapping. Includes tools on investigations as well as investigative questions. This series of slides with narrative voiceovers includes the following separate modules: CAPA Plan Development ToolsEffectiveness ChecksCase StudiesRoot Cause Investigation Tools5 WhysStructured BrainstormingFishbone ToolFishbone with Gilbert Behavior Engineering Model (BEM)BEM Interview Guide ExampleSMARTS Guiding PrinciplesEffectiveness Check ToolsProvides detail and points to consider for a sponsor when determining an approach for corrective and preventive checks. Includes scenarios that illustrate actions that could be taken to contain or stop the effect of an Issue that Matters, as well as scenarios of both corrective and preventative effectiveness checks. Quality Management System
QMS Issues that Matter 
Notification and
 Escalation Strategy This tool includes slides with a narrative voiceover provided by an expert from the QMS Initiative.This module covers points to consider, along with scenarios, to assist sponsors in establishing an issue triage mechanism that assesses the impact of an issue.Enables users to differentiate between Issues That Matter, which are managed through a robust CAPA process, and issues that will be managed according to an organization’s tolerance to risk (thresholds); provides guidance on determining triage thresholds. Quality Management System
Quality Risk Management Framework: Best Practices for Implementation of Risk Management in Clinical Development Webinar This webinar topic is one of two that will educate and inform interested audience members about the TransCelerate Clinical Quality Management System (CQMS) conceptual framework, as well as the Risk Management and the Processes Frameworks published by TransCelerate.  Quality Management System
Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development (Paper) Describes a framework for effective risk management within clinical development. Assists organizations in understanding the benefits and basic components of risk management in clinical development. Includes a suite of change management tools. Quality Management System
Quality Tolerance Limits FAQs A compilation of FAQs and responses. Interpretation of Clinical Guidances & Regulations
Quality Tolerance Limits Framework A framework including a proposed definition of the term ‘QTL’ , process maps/steps and examples of QTL parameters. Interpretation of Clinical Guidances & Regulations
Quality Tolerance Limits Framework & Webinar A framework including a proposed definition of the term ‘QTL’ , process maps/steps and examples of QTL parameters. The "Demystifiing Quality Tolerance Limits" webinar reviews guidance and considerations for QTL implementation in clinical development. Interpretation of Clinical Guidances & Regulations
Quality Tolerance Limits Plan Template A template intended to aide sponsors in developing their own QTL monitoring plan. Interpretation of Clinical Guidances & Regulations
Quality Tolerance Limits Text for the Common Protocol Template (CPT) and Clinical Study Report (CSR) We think since this is based in CC&R it probably should be listed under that in the Matrix and Alphabetical list Interpretation of Clinical Guidances & Regulations
Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development A peer-reviewed publication sharing the work done on the definition of the term ‘QTL’ and parameter guides. Interpretation of Clinical Guidances & Regulations
Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development A peer-reviewed publication sharing the work done on the definition of the term ‘QTL’ and parameter guides. Interpretation of Clinical Guidances & Regulations

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Initiative Solution Description Initiative
Rapid Real-World Data Analysis Plan for Signal Assessment Template The Alternative to a Full Protocol offers a potential alternative to a full study protocol for use in the RSA process, which is described in the RSA RWD Framework. It is a generic template for rapid non- or less-complex RWD analysis types, which typically would not require a full study and protocol, along with guidance for its usage.  Rapid Signal Assessment Using Real World Data
RBM Interactive Guide A multi-chapter, interactive guide to all risk-based monitoring components. Risk Based Monitoring
Recommendations for Drafting Non-Promotional Lay Summaries of Clinical Trial Results, as referenced in the Layperson Summaries in Clinical Trials: An Implementation Guide Intended to provide general principles to help sponsors prepare lay summaries in a manner that reduces the risk that the summaries could be perceived as promotional, which would raise regulatory concerns. Clinical Research Access & Information Exchange
Registry of the Future Wireframe A proposal and wireframe mock-up, designed in conjunction with patients, illustrating patient-focused improvements for adoption to be incorporated into clinical trial registries to improve utility and access to clinical trial information. Clinical Research Access & Information Exchange
Reimbursement IRB Insights Webinar & Read Along The objective of this content is to reduce time and effort of sponsor study teams when making decisions on what and how much can be reimbursed by: providing insights on what IRBs consider to be appropriate and allowable reimbursement practices for clinical trial patients; and providing guidance on how to reimburse while reducing the risk of coercing patients to participate in clinical trials. Diversity of Participants in Clinical Trials
Resources for Authors Word document with bulleted listing of resources (hyperlinked) for use in developing a protocol or designing or implementing a trial. Clinical Content & Reuse
Reuse Assessment Form A template for assessing the reuse of data for a possible research activity. Interpretation of Clinical Guidances & Regulations
Rheumatoid Arthritis Therapeutic Area library for Rheumatoid Arthritis trials. Clinical Content & Reuse
Risk Indicator Allows clinical organizations to better understand how to embed this element of RBM into their business. Risk Based Monitoring
Risk-Based Monitoring Data Quality Management "Implementation considerations for establishing quality tolerance limits (QTLs) and risk reporting in the clinical study report (CSR) are examined and described. This framework aims to be consistent with ICH E6 (R2) and TransCelerate papers on Risk Based Monitoring (RBM) and Quality Management System (QMS)." Risk Based Monitoring
Risk-Based Monitoring Metrics Solutions/Change Tools These tools delve deeper into the metrics for measuring RBM impact. Risk Based Monitoring
Risk-Based Monitoring Risk Assessment and Categorization Tool (RACT) & Tools A model approach to apply Risk-Based Monitoring, to direct monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality. Supported by a suite of tools to facilitate implementation, including a library of >100 risk indicators which sponsors may choose to apply in their clinical trials. Risk Based Monitoring
Risk-Based Monitoring Technology Considerations (Papers) Two papers hat delve deeper into the technology considerations of RBM. Risk Based Monitoring
Risk-Based Monitoring Updates RBM methodology and revisions based on lessons learned from application of the tools. Risk Based Monitoring
Risk-Based Quality Management: Quality Tolerance Limits and Risk Reporting In this paper, implementation considerations for establishing quality tolerance limits (QTLs) and risk reporting in the clinical study report (CSR) are examined and described. This framework aims to be consistent with ICH E6 (R2) and TransCelerate papers on Risk Based Monitoring (RBM) and Quality Management System (QMS). Risk Based Monitoring

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Initiative Solution Description Initiative
Safety Issue Notification Guidances & Regulations: Safety Issue Notification Webinar A webinar presentation where TransCelerate team members provide an overview of the Safety Issue Notification Guide. Interpretation of Pharmacovigilance Guidances & Regulations
Safety Issue Notification Guidances & Regulations: Safety Issue Notification Guide A guide to aide understanding of safety issue notification guidances for in-scope countries. Interpretation of Pharmacovigilance Guidances & Regulations
Sample Thank You Letter Provides a sample Thank You Letter to thank participants for taking part in the study and provides information on how, when, and where the results and/or layperson summaries will be made available to participants. Clinical Research Access & Information Exchange
SAP Estimands Example Document Word document with proposed guidance and examples that can be used across the CPT and SAP documents when completing information around Objectives, Endpoints, and Estimands. Clinical Content & Reuse
Searching for Clinical Trials Video Narrated video highlights new ways patients might search for and narrow down clinical trial options, as demonstrated in the Clinical Trial Registry of the Future concept. Clinical Research Access & Information Exchange
SEND Harmonization & Cross-Study Analysis: A Proposal to Better Harvest the Value from SEND Data (Paper) Identifies common variability in certain SEND domains and to describe how variability can be managed to enable valuable cross-study analysis use cases. Also includes a webinar and overview on the implementation and use of CDISC SEND data packages with the aim of facilitating study analysis. BioCelerate
Shared Investigator Platform Alongside the Investigator Registry, a combined solution providing accelerated identification of qualified investigators, facilitates site/sponsor interactions, and reduces administrative burden of clinical trial operations. Now owned and maintained by Cognizant. Shared Investigator Platform
Sharing Historical Trial Data to Accelerate Clinical Development (Paper) A paper on sharing historical trial data to accelerate clinical development which highlights TransCelerate's Placebo/Standard of Care data sharing and DataCelerate. Historical Trial Data Sharing
Showing Gratitude to our Clinical Trial Participants throughout the Clinical Trial Journey Infographic Highlights how the Patient Experience Gratitude Toolkit can be used to show appreciation to patients and caregivers throughout their clinical trial journey and the potential benefits it may have to both patients and sponsors. Patient Experience
Signal Management-Intelligent Automation Opportunities for Signal Detection Identifies how a representative sampling of major pharmaceutical companies are currently using intelligent automation for various PV process steps within a generic signal management framework and thereby raises awareness as to the potential opportunities for the broader industry in this area.  Intelligent Automation Opportunities in Pharmacovigilance
Site Level Risk Assessment Considerations Provides examples to help demonstrate possible alternatives for quantifying initial and ongoing site level risk. Risk Based Monitoring
SPFQ Implementation User Guide The SPFQ Implementation User Guide is intended to support each sponsor company’s customization and implementation of the SPFQ. Patient Experience
SPFQ Socialization Presentation The socialization deck offers customizable materials providing an introduction to the SPFQ and how it may improve patient centricity in your studies. Patient Experience
Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity, and Inclusion of Participants in Clinical Trials (DEICT) This toolkit is comprised of a set of mitigation considerations designed to support efforts to sustainably partner with sites to enable the enrollment and retention of underrepresented patient populations in clinical trials. These mitigation considerations consist of perspectives from a series of stakeholder discussions and a Diversity Roundtable event and suggest considerations across different maturity levels. Diversity of Participants in Clinical Trials
Statistical Analysis Plan Implementation Tools A set of tools to enable assessment and adoption of the CC&R SAP Suite. Clinical Content & Reuse
Statistical Analysis Plan Word Version Document template with common structure and proposed model content, aligned with ICH E9. Integrates with CPT and CSR templates. Clinical Content & Reuse
Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct (Paper) Explores a a cross-functional, collaborative approach to statistical monitoring that can adapt to study design and data source and use a combination of statistical screening techniques and confirmatory graphics. Risk Based Monitoring
Study Definitions Repository Reference Implementation & Associated Source Code A functioning, example approach showing how the Unified Study Definitions Model can be represented as a novel central component to connect systems that produce protocol information with those that consume it to drive study operations.   Digital Data Flow
Study Definitions Repository Reference Implementation Minimal Viable Product The SDR Reference Implementation enables the format of information from a digitized protocol and other sources to be standardized and stored centrally. This allows information to be passed to systems through application programming interfaces (APIs) used for study execution and data collection and reused throughout the clinical development lifecycle. Study Definitions Repository Reference Implementation Minimal Viable Product
Study Participant – Frequently Asked Questions Provides guidance when discussing the results of the study with the participants and answering study participants’ questions in a non-promotional manner. Clinical Research Access & Information Exchange
Study Participant Feedback Questionnaire (SPFQ) The Study Participant Feedback Questionnaire (SPFQ) is a survey provided to study participants at the beginning, middle and end of a clinical study. Use of the SPFQ is intended to improve patient centricity in clinical studies. Patient Experience
Study Participant Feedback Questionnaire FAQ Offers a collated list of questions and answers structured and categorized across key content topics as defined in the SPFQ Implementation User Guide.     Patient Experience
Study Participant Feedback Questionnaire Toolkit Implementation User Guide Intended to support each sponsor company's customization and implementation of the SPFQ. Patient Experience
Study Participant Feedback Questionnaire Toolkit Question Bank Addendum Provides new and replacement questions for SPFQ Version 1.0, addressing motivation to participate, gratitude, and decentralized clinical trial activities. Patient Experience
Study Participant Feedback Questionnaire Toolkit Socialization Presentation The socialization deck offers customizable materials providing an introduction to the SPFQ and how it may improve patient centricity in your studies. Topics covered include an introduction to TransCelerate, value proposition, toolkit overview, and how to build an SPFQ network. Patient Experience
Summary of Changes in 2021 Release Powerpoint slides describing the content and technology revisions and enhancements to the TrasCelerate Clinical Template Suite and eTemplates. Clinical Content & Reuse
Summary of Cumulative Content Changes (CPT, SAP, CSR) Excel spreadsheet listing detailed content updates by document and section across all the releases with rationale. Clinical Content & Reuse
Supporting Automation of Case Report Forms Using Biomedical Concepts A short video introducing biomedical concepts and the benefits of this data model concept in the study lifecycle.    Digital Data Flow
Supporting Materials for Consent Specific to Clinical Data Reuse This educational toolkit can be used by study sponsors to help clinical trial participants better understand the data protection measures that will be applied to their personal data. To increase user-friendliness, technical terminology, such as ‘anonymization’ or ‘pseudonymization’, and how this relates to the protection of personal data, is avoided. The supporting document provides important context about the educational tool and can aid study sponsors in answering common questions asked by IRBs and Ethics Committees. Privacy Methodology for Data Sharing
Systematic Approach to Pharmacovigilance Negotiations Gantt Chart Provides a project plan template to help manage PVA negotiation timelines between the PVA partners.  Pharmacovigilance Agreements Optimization
Systemic Approach to Pharmacovigilance Agreements Negotiations A presentation slide deck that can be used to plan and facilitate a kick-off meeting with negotiation stakeholders before drafting a PVA. Pharmacovigilance Agreements Optimization

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Initiative Solution Description Initiative
Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective (Paper) Provides insights into the technological complexities, operational scope, and the actions required from pharmaceutical industry stakeholders to adopt the eSource framework for clinical research at scale. eSource
Technology Considerations to Enable the Risk-Based Monitoring Methodology (Paper) Lays out the high-level considerations when designing and building an integrated technology solution that will aid in scaling the methodology across an organization’s portfolio. Risk Based Monitoring
Thank You Templates Template of an example letter created to identify the key pieces of information that could be included in a communication to a clinical study participant after he/she has enrolled in a clinical study. Clinical Research Access & Information Exchange
The Art of the Possible Video Video describing what factors to consider when designing a universal eLabel. eLabels
The Evolving Remit of the Reference Safety Information: Observations on Implementation of the 2017 Clinical Trials Facilitation Group (CTFG) Question & Answer Document This manuscript highlights industry challenges in operationalizing the requirements of the 2017 Clinical Trial Facilitation Group (CTFG) Question & Answer document. Surveys reveal actions taken in the creation, submission and implementation of the Reference Safety Information (RSI) to meet the requirements of the CTFG and EU national competent authorities whilst staying compliant with global regulatory requirements. Interpretation of Pharmacovigilance Guidances & Regulations
The Interactive ICSR & Automation Technologies Tool (IATT) Video A video explaining the background and rationale for the Interactive ICSR and Automation Technologies Tool (IATT). The demo shows an interactive process flow depicting each process step within the individual case safety report (ICSR) process. Intelligent Automation Opportunities in Pharmacovigilance
The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites and Sponsors Paper The publication provides an overview of concepts, defines terminology and offers a discussion about the misconceptions related to the use of both eLabels and universal labels. eLabels
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8 The aim of this paper is to enhance the understanding of specific topics detailed in ICH E8 including QbD, CtQ, Fit for Purpose, and Stakeholder Engagement.   Interpretation of Clinical Guidances & Regulations
Thinking Outside The Box: Placebo Standard of Care Data Solution Video Discover how TransCelerate's Historical Trial Data Sharing (Controls) Solution is working to improve clinical trial design, better manage study participants, and enhance innovative drug development. Please note, this initiative was formerly known as Placebo and Standard of Care (PSoC). You may see references to PSoC in this video and throughout our website as we continue to update our content. Historical Trial Data Sharing
Time Points: Supporting Protocol Digitization with Complex Timing Components A short video introducing time points and how it can be used to support complex study designs.  Digital Data Flow
Toolkits to Help Amplify the Patient Voice in Clinical Research Infographic An infographic that shows why and how the Patient Protocol Engagement Toolkit (P-PET) and Study Participant Feedback Questionnaire (SPFQ) Toolkit were created with patient advisors and R&D experts. Patient Experience
Toxicology Data Sharing: Leveraging Data Sharing to Enable Better Decision Making in Research and Development (Paper) Facilitates understanding of Toxicology Data Sharing and the development process. BioCelerate
Toxicology Data Sharing/DataCelerate Use Cases Examples of utilizing the DataCelerate platform to enable sharing, searching, viewing and downloading nonclinical toxicology and background control data across BioCelerate Member Companies. BioCelerate
TQT Therapeutic Area library for TQT trials. Clinical Content & Reuse
TransCelerate eTemplates YouTube Playlist Narrated videos demonstrating the functionality of the TransCelerate eTemplates. Clinical Content & Reuse
TransCelerate Moves Clinical QMS from Vision to Conceptual Framework Podcast Pre-competitive collaboration among pharmaceutical companies is leading to advances in critical aspects of drug development. This podcast delivers expert discussion of TransCelerate's Clinical Quality Management Systems, based on their article TransCelerate's Clinical Quality Management System: From a Vision to a Conceptual Framework in the July 2016 issue of Therapeutic Innovation & Regulatory Science (TIRS). Quality Management System
TransCelerate Risk-Based Monitoring Technology Considerations Part 2 This white paper presents functionality details for an integrated Risk-Based Monitoring technology solution. Risk Based Monitoring
TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework (Paper) Identifies methods for operationalizing in integrated QMS through which sponsors can systematically plan, control quality, monitor and improve performance in complex clinical research environments. Includes a suite of change management tools. Quality Management System
TransCelerate’s Clinical Quality Management System: Issue Management (Paper) Describes a framework for effective issue management within clinical development. Includes a suite of change management tools. Quality Management System
TransCelerate’s Patient Experience Initiative: An Introduction Video A video that explains how TransCelerate-developed tools can help provide more effective ways to engage with patients in the design and execution of clinical studies. Patient Experience
TransCelerate’s Clinical Quality Management System – An Overview and Tools for Industry Use Webinar Video provides an overview of the TransCelerate clinical QMS developed as a customizable approach for companies to use. Quality Management System
Translated CPT Resources Common Protocol Templates translated into Japanese. Clinical Content & Reuse
Translated TransCelerate Solutions TransCelerate Member Companies have translated select solutions for potential use with the broader global community. Current translations include solutions within Clinical Content & Reuse, Site Qualification & Training, Quality Management Systems, and Patient Experience.

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Initiative Solution Description Initiative
U.S. Regulatory Landscape: Diversity in Clinical Trials This regulatory landscape resource is designed to help identify key U.S. legislation and U.S. FDA policy, regulation, and guidance as well as regulatory precedent to consider when working to understand and improve diversity & inclusion (D&I) of adult patients in clinical trials, focusing on the inclusion of racial and ethnic minorities. Diversity of Participants in Clinical Trials
Understanding Case Reporting Transmission Networks in Drug Safety: The Impact of Replication Webinar This webinar recording is a presentation and panel discussion on TransCelerate's Individual Case Study Report Replication paper, the first quantification of the phenomenon of ICSR replication across Health Authority and marketing authorization holder safety databases. The panel discusses the value of reducing the duplicative, replicated ICSR-related activities and the impact of that reduction on patient safety and prompting discussions about mitigating regulatory and technical approaches. The webinar can be watched at Understanding Case Reporting Transmission Networks in Drug Safety: The Impact of Replication - YouTube. Presentation slides can be accessed here.
Unified Study Definitions Model Developed with CDISC, USDM provides the standard data model, controlled terminology and APIs needed to specify and share a protocol design in a digital format. USDM v2.0 includes the addition of biomedical concepts and complex time points into the model.  Digital Data Flow
Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities (Paper) Facilitates understanding of intelligent automation technology-related terms in the PV context. Also, it includes a summary of current use cases. Intelligent Automation Opportunities in Pharmacovigilance

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Initiative Solution Description Initiative
Vaccines Therapeutic Area library for Vaccine trials. Clinical Content & Reuse
Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices (Paper) This position paper provides considerations to the industry on validation strategies that can be utilized for emerging AI-based automation technologies. It is intended to facilitate dialogue and collaboration with Health Authorities and industry on this topic. Intelligent Automation Opportunities in Pharmacovigilance
Vendor and Sponsor Engagement Considerations Toolkit A set of considerations developed with vendor insights to assist the facilitation of more routine two-way feedback discussions on the deployment of patient technology. The document is designed to help enable open discussion environments between parties where learnings can be shared, documented and leveraged for future studies. Patient Technology
Vendor Gifographic An engaging and insightful graphic describing key findings from surveys and interviews of patient technology vendors. Includes identification of industry challenges and ways to improve vendor and sponsor working relationships. Patient Technology

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Initiative Solution Description Initiative
What is a Clinical Quality Management System? Video This video highlights TransCelerate's CQMS conceptual framework, which will provide a holistic clinical quality management system, in turn saving time, increasing efficiencies, and ultimately providing a safer experience for patients. Quality Management System
What is an eLabel? Video Video describing the eLabel concept. eLabels
What is Digital Data Flow? Video Video describing the Digital Data Flow concept. Digital Data Flow
What is eConsent? Video Video describing the eConsent concept. eConsent
What is the Clinical Trial Registry of the Future? Video Narrated video describes the purpose of the Clinical Trial Registry of the Future concept and the principles of its design. Clinical Research Access & Information Exchange
What Patients Want to See in Clinical Trial Registries Infographic The infographic, based on a global patient survey with 1,070 responses, details what information is helpful when patients begin their search for clinical trials in a registry, and what information patients would like to see in the brief title and brief summary. Clinical Research Access & Information Exchange
What You Need to Know about ICH E8 Infographic An easily sharable and digestible document for introducing and interpreting key components of ICH E8 such as Critical to Quality Factors, Open Dialogue, Critical Thinking, and Fit for Purpose. ​ Interpretation of Clinical Guidances & Regulations
What You Need To Know About Quality Tolerance Limits Infographic An infographic introducing how a QTL is defined, how they fit into the broader context of a Quality Management System and when action may be taken because of a QTL. Interpretation of Clinical Guidances & Regulations
White Paper: Common Protocol Template and Disclosure to Clinical Trial Registries Word document (5 pages) describing the advantage of using CPT when completing processes associated with disclosure to Clinical Trial Registries. Clinical Content & Reuse
Why Common Templates? Initiative Overview Provides an overview and background of the nonclinical common protocol template project. Common Templates for Nonclinical Studies

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