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a

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 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
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
Approaches to Implementing in Your Organization

Powerpoint slides describing options for company adoption of assets along with references to Mapping Table Exercises to assess impact of adoption of CPT, SAP, CSR templates.

Clinical Content & Reuse
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
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

b

Initiative Solution Description Initiative
Breast Cancer

Therapeutic Area library for Breast Cancer trials.

Clinical Content & Reuse

c

Initiative Solution Description Initiative
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 Content & Reuse Implementation Toolkit

A set of tools to enable assessment and adoption of the Clinical Content & Reuse Suite.

Clinical Content & Reuse
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 – Executive Summary for Sponsor Senior Leaders

Powerpoint slides summarizing 'why' we have a common protocol template (CPT), how CPT was developed, and the value proposition for common statistical analysis plan (SAP) and clinical study report (CSR) templates.

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 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
Collaboration with FDA and NIH

Powerpoint slides detailing the history of TransCelerate collaboration with NIH and FDA during the development of the CPT and NIH's eProtocol solution.

Clinical Content & Reuse
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 Clinical Study Report Word Version

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.

Clinical Trial Diversification
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 and Disclosure: Connecting Critical Processes

Powerpoint slides describing how the protocol "fits" in the clinical trial disclosure process and how elements of the TransCelerate CPT are enablers to process efficiency.

Clinical Content & Reuse
CPT Implementation Tools

A set of tools to enable assessment and adoption of the Common Protocol Template.

Clinical Content & Reuse
CPT Mapping Exercise

Zip file containing instructions and mapping spreadsheet for companies to compare their existing protocol templates to the CPT when considering adoption.

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
CTS Sponsor Implementation Experience Highlights & Tips

Powerpoint slides listing highlights and experiences from various stakeholders and perspectives.

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.

Clinical Trial Diversification
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
Data Monitoring Committee Apprentice Model Mentoring framework which defines a model for enabling seasoned DMC members to aid new DMC candidates in gaining relevant experience. Data Monitoring Committee
Data Monitoring Committee Registry Concept Video Visual representation of a publicly available and searchable DMC registry. Demonstrates how DMC organizers would connect with DMC candidates. Data Monitoring Committee
Data Monitoring Committee Registry Prototype eBook

Demonstrates the purpose and functionality of the proposed DMC Registry.

Data Monitoring Committee
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
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
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 Communications Materials Materials (DDF Executive Summary, DDF Problem Statement & Future State Narrative, 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 Solution Framework & Conceptual Design Describes a potential Solution Framework and Conceptual Design that will help technology providers create an innovative, central protocol platform that will be accessible, open, flexible and vendor-agnostic toward downstream clinical applications. Digital Data Flow
Diversification Practices Guidance for sponsors and clinical trial sites regarding better practices and processes for minority recruitment. Clinical Trial Diversification
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.

Clinical Trial Diversification

e

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 Global Landscape Assessment Global map and detailed reports based on blinded and aggregated data about industry experience providing information on trends in the global 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 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

A template that can be used to develop necessary roles and resources needed for eLabels implementation and support.

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 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
eSource Site Maturity Curve

The objective of the Site Maturity Curve is to help study sites determine their readiness for eSource implementation, by identifying their level and pathway to increase interoperability. Interoperability is key to the exchange of source data electronically for research. The maturity curve includes a diagram that shows different levels 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
eTemplate Implementation Considerations

Powerpoint slides summarizing member company interview feedback related to implementation of the CTS eTemplates.

Clinical Content & Reuse
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
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

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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 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

g

Initiative Solution Description Initiative
Getting Started with the Basic Word Editions (MS Word)

Powerpoint slides describing how to locate and download the CPT, CSR and SAP templates on the TransCelerate site.

Clinical Content & Reuse
Getting Started with the eTemplates

Powerpoint slides describing how to get started using eTemplates including a linked list of how-to videos for use of the eTemplates.

Clinical Content & Reuse
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

h

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
History and Evolution of Clinical Template Suite Releases

Powerpoint slides providing the history of CTS development and alignment with stakeholders; nomenclature and summary of releases (as of Q42020); and, comparison versions available for assets.

Clinical Content & Reuse
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
How was the CPT developed and what does it look like?

Powerpoint slides describing the methodology used to develop the CPT with a focus on structure and content; the role of external engagement and feedback; and what the CPT looks like.

Clinical Content & Reuse
How was the CSR developed and what does it look like?

Powerpoint slides describing how the common CSR was developed, look of template and eCSR utility.

Clinical Content & Reuse
How was the SAP developed and what does it look like?

Powerpoint slides describing the SAP, how the common SAP was developed, benefits of use, look of template and eSAP utility, and implementation.

Clinical Content & Reuse

i

Initiative Solution Description Initiative
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
Implementation Toolkit and Guidance for the Implementation Leader

Powerpoint slides explaining the utility of assets and role of member company (MC) in implementation.

Clinical Content & Reuse
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 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
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 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.

Clinical Trial Diversification
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
Introduction to TransCelerate BioPharma Inc.

Powerpoint slides describing Transcelerate as a non-profit organization, member companies involved, the collaborative reach and mission.

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
IT Considerations for Implementation

Brief powerpoint slideset of IT support considerations for companies implementing the CTS eTemplates.

Clinical Content & Reuse

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l

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

m

Initiative Solution Description Initiative
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

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o

Initiative Solution Description Initiative
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
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

p

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
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.

Clinical Trial Diversification
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 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 Benefits
Patient Burden
Patient Compliance
Patient Consent and Comprehension
Patient Experience
Patient Safety
Patient Willingness to Participate
Privacy
Technology Maintenance
Technology Support
User Experience Design

Patient Technology
Patient Technology Regulatory Landscape Tool Collates U.S. and European regulations and guidances related to digital technologies and their use in clinical trials. 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
Perspectives on a cQMS Video

Video describing a proposed Clinical QMS framework.

Quality Management System
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
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
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
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 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 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 Tools
Effectiveness Checks
Case Studies
Root Cause Investigation Tools
5 Whys
Structured Brainstorming
Fishbone Tool
Fishbone with Gilbert Behavior Engineering Model (BEM)
BEM Interview Guide Example
SMARTS Guiding Principles
Effectiveness Check Tools
Provides 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

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Initiative Solution Description Initiative
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.

Clinical Trial Diversification
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
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
SAP Mapping Exercise

Zip file containing instructions and mapping spreadsheet for companies to compare their existing statistical analysis plan templates to the SAP when considering adoption.

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
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
Stakeholder Assessment

Spreadsheet listing stakeholder groups versus corresponding impact of changes to the various templates.

Clinical Content & Reuse
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 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
Summary of Changes in 2020 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

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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 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
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
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

u

Initiative Solution Description Initiative
Update on Use and Maintenance/Governance

Powerpoint slides describing current download statistics, data from 2019 member company implementation survey, and highlights of the governance and maintenance cycle.

Clinical Content & Reuse
Using Clinical Template Suite Libraries

Powerpoint slides covering the use of libraries within the CTS (both the basic word and eTemplate versions); highlighting their value to content reuse, how the were developed, what libraries are available, and where to locate them.

Clinical Content & Reuse
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

v

Initiative Solution Description Initiative
Vaccines

Therapeutic Area library for Vaccine trials.

Clinical Content & Reuse
Variable Use Across eTemplates

Powerpoint slides discussing the current and potential content reuse opportunities related to the CTS and describe the use of the eTemplates Variable Reuse Map tool.

Clinical Content & Reuse
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
Voluntary Adoption Decision Tree

Process flow diagram describing how a company may adopt the CTS and then how to update based on a new version.

Clinical Content & Reuse

w

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
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 a Common Protocol Template? 

Powerpoint slides describing why the CPT was developed and why it is useful, approach for development and lastly, what the CPT is not.

Clinical Content & Reuse

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y

z

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