The Interpretation of Clinical Guidances & Regulations Initiative shares expertise to more efficiently and effectively meet the intent of ambiguous regulations/guidances and Health Authority operational expectations around the world. Secondarily, the initiative will take opportunities to raise Health Authority awareness of the real-life impact of ambiguous regulations/guidelines. While addressing these aims, the initiative will consider the highest priority to be continued enhancement of patient safety.
Current Topics:
Quality and Culture Solutions for Operationalizing ICH E6(R3)
ICH has finalized its renovation of the GCP Guidelines with ICH E6(R3). This updated guideline incorporates internationally accepted principles and practices in the design and conduct of studies, ensuring the protection of study participants and facilitating the acceptance of data and results by health authorities. As with any new or updated ICH or regulatory guidelines, stakeholders in the clinical trial ecosystem may have questions and face challenges in implementing and operationalizing the new requirements. These solutions are intended to aid in this process.
Guidance: ICH E6(R3) – Final version
Agency: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Effective Date: Adopted on 06 January 2025
Deliverables:
Refer to the ICH E6 Asset Library for tools.
Approach
TransCelerate Solution Development:
The TransCelerate team has been monitoring the progress of the ICH E6(R3) revision and has developed solutions and tools to support the implementation of changes. These solutions and tools are available in the ICH E6 Asset Library.
With the finalization of ICH E6(R3), the TransCelerate team is reviewing the revised guideline to determine if additional support is needed in any of the deliverables created to aid stakeholders in operationalizing ICH E6(R3).
Industry Collaboration Efforts: Following the release of the ICH E6(R3) draft dated 19 May 2023, the TransCelerate workstream identified six focus areas for solution development. Of these six areas, TransCelerate has partnered with the Association of Clinical Research Organizations (ACRO) to co-develop solutions within two focus areas: risk management and data governance. Deliverables co-developed with ACRO are highlighted in the ICH E6 Asset Library.
Value
Providing a framework for implementation will facilitate the industry’s efforts to efficiently operationalize the principles specified in the revised guidelines. TransCelerate’s ICH E6 project provides tools and solutions for clinical study stakeholders to foster collaboration, achieve greater efficiency and effectiveness in operationalizing the revised ICH guidelines, and better support regulatory compliance. The project will accelerate adoption across various stakeholder groups in the clinical research ecosystem.
Quality and Culture Solutions for Operationalizing ICH E8(R1)
ICH is in the process of renovating its GCP Guidelines, ICH E8(R1) has been revised. This ICH project has updated the internationally accepted principles and practices in the design and conduct of studies that will ensure the protection of study participants and facilitate the acceptance of data and results by health authorities. As is typical with new or updated ICH or regulatory guidelines, stakeholders in the clinical trial ecosystem likely will have questions and face challenges in implementing and operationalizing the new requirements. These solutions are intended to aid in this process.
Guidance: ICH E8(R1)
Agency: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Effective Date: ICH E8(R1) – October 2021
Approach
TransCelerate Solution Development:
- The TransCelerate team developed a framework comprising several components to provide greater clarity and context for ICH E8(R1), which are listed below.
Value
Providing a framework for implementation will facilitate industry’s efforts to operationalize efficiently the principles specified in the revised Guidelines. TransCelerate’s ICH E8 project provides tools and solutions for clinical study stakeholders to foster collaboration, achieve greater efficiencies and effectiveness in operationalizing the revised ICH Guidelines, and better support regulatory compliance. The project will accelerate adoption across various stakeholder groups in the clinical research ecosystem.
Deliverables
| Asset Type | Title | Description |
 | The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8 – Publication | The aim of this paper is to enhance the understanding of specific topics detailed in ICH E8 based on direct feedback from TransCelerate member companies who identified Quality by Design (QbD), Critical to Quality (CtQ), Fit for Purpose, and Stakeholder Engagement, as most changed and open to interpretation. |
 | What You Need to Know About ICH E8 (R1) Webinar | This webinar discusses TransCelerate’s tools and resources for ICH E8 (R1) and its implementation. These solutions target key new concepts in ICH E8, such as Critical to Quality Factors, Stakeholder Engagement, Critical Thinking, and Open Dialogue. The webinar focuses on what’s new in ICH E8 (R1), our work and how our focus topics were chosen, and an overview of the published tools. Link to the presentation content. |
| 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. |
| ICH E8 Case Studies | A collection of three sponsor company case studies to demonstrate ICH E8 (R1) concepts in action. These case studies aim to provide ideas and examples for practical implementation of ICH E8 (R1). |
| ICH E8 Landscape Assessment | Benchmarking information gathered from a survey of sponsor companies to help understand the progress and challenges of ICH E8 (R1) Implementation. |
| Stakeholder Engagement for Clinical Development | A tool to help study sponsors manage quality by facilitating implementation of ICH E8’s principles regarding stakeholder engagement throughout the lifecycle of clinical development. |
| 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). |
| 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. |
Completed Topics:
These topics are complete. No new solutions or updates are planned.
A Privacy Framework for Clinical Data Reuse: Secondary Data Use in the Pharmaceutical Industry
This framework has been developed to decrease the time companies spend addressing privacy questions related to research and increase the potential reuse of clinical data. An increase in this data reuse would ultimately reduce the burden on patients, with less data needing to be collected as the use of existing data was maximized.
With a focus on privacy the framework introduces six principles and a best practice process model for reuse of clinical data for research purposes. Furthermore, the framework provides examples of potential primary and secondary uses of research data in the pharmaceutical industry.
As the EU General Data Protection Regulation (GDPR) has become a global inspiration for data protection legislation it has been used as the basis for developing the framework. However, the framework can also be utilized with other privacy regulations and requirements.
Guidance: EU General Data Protection Regulation
Agency: European Commission
Effective Date: May 2018
Approach
- The team reviewed the 2018 regulation and relevant opinions and guidance in regards to data reuse.
- The team then developed a framework to provide greater clarity on proposed principles for management of data reuse.
Value
Data reuse has the potential to decrease the time companies spend addressing privacy questions related to research and increase the potential reuse of clinical data. An increase in this data reuse would ultimately reduce the burden on patients, with less data needing to be collected as the use of existing data was maximized.
This framework is meant for companies developing their internal data reuse processes in compliance with privacy regulations. However, it could also be relevant for cross company research collaboration and subsequent sharing of data.
Deliverables
| Asset Type | Title | Description |
| 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. |
| 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. |
Tools for Reuse of Clinical Data
| Asset Type | Title | Description |
| Glossary | A glossary, which provides definitions relevant to key terms within the framework. |
| Definition of Primary and Secondary Use of Clinical Data | Examples of potential primary and secondary uses of clinical data within the pharmaceutical industry. |
| 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. |
| Reuse Assessment Form | A template for assessing the reuse of data for a possible research activity. |
Quality Tolerance Limits: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical
Guidances: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
Agency: ICH
Guidance Date: November 2016
Approach
- The topic team reviewed the 2016 Guidance and identified areas that may need clarification.
- The topic team then provided greater clarity on how to interpret and operationalize QTLs as per ICH E6 R2 through deliverables (see below).
Value
This topic’s objective was to improve the systematic quality of Clinical Research by facilitating the implementation of Quality Tolerance Limits (QTLs) in ways that advance compliance and efficiency but minimize confusion and duplication of effort.
Deliverables
| Asset Type | Title | Description |
| Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials | A peer-reviewed publication showing that historical parameter values can provide helpful benchmark information for quality control activities in future trials. |
| Quality Tolerance Limits Framework | A framework including a proposed definition of the term ‘QTL’ , process maps/steps and examples of QTL parameters. |
| 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. |
| 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. |
| Quality Tolerance Limits Plan Template | A template intended to aide sponsors in developing their own QTL monitoring plan. |
| Quality Tolerance Limits FAQs | A compilation of FAQs and responses. |
| Quality Tolerance Limits Text for the Common Protocol Template (CPT) and Clinical Study Report (CSR) | Model instructional text for inclusion in the TransCelerate Clinical Content & Reuse Initiative CPT and CSR Templates. |
| 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. |