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臨床試験情報開示に関する自己評価：Citeline成熟度モデルへようこそ

このインタラクティブツールでは、貴社の情報開示の取り組みを包括的に評価できます。強みを把握し、改善すべき領域を特定し、透明性とコンプライアンスの向上に向けた明確な道筋を描くことができます。

評価を進める中で、各領域における最も効果的な改善ポイントを提示し、優先順位の設定、プロセスの最適化、リスクの軽減、ステークホルダーとの信頼構築を支援します。

評価を始めるには、領域を選択してください：

Disclosure Process Management

Why this domain matters: The disclosure process management domain is the operational core of clinical trial transparency efforts. It shapes how organizations execute their disclosure activities, from initial planning to final publication.

Process Standardization & Harmonization

How would you characterize your organization's approach to standardizing and harmonizing disclosure processes?

Disclosure processes are managed ad hoc, with minimal reliance on formalized standard operating procedures (SOPs), and we don’t have disclosure-specific SOPs. Some disclosure SOPs exist but do not consistently reflect current practices and may be insufficiently detailed. We have comprehensive SOPs that cover most disclosure activities for the US and the EU but not for all global registries or all trial types, including observational studies or expanded access programs. We have comprehensive and up-to-date SOPs governing all disclosure activities. Processes are harmonized across trials and registries, ensuring consistent and reliable disclosure practices.

Workflow Management & Tracking

How does your organization manage and track disclosure workflows?

Disclosure workflows are manual, with minimal oversight and no tracking. Basic tracking mechanisms exist, but processes are not fully optimized or automated, and tracking may be inconsistent. We have implemented workflow management systems for most disclosure activities, but some manual processes remain. We have fully automated workflow management systems, ensuring efficient task assignment, progress tracking, and timely completion of all disclosure activities.

Disclosure Planning

How does your organization approach disclosure planning?

Our disclosure activities are reactive and unplanned, leading to missed deadlines. Basic planning occurs for some disclosure activities, but various aspects remain reactive, and timelines are inconsistently met. We have formal project management processes for most disclosure activities, but these may not cover all aspects of the disclosure process. We use formal project management methodologies to create and manage detailed disclosure plans that consider all aspects of the disclosure process.

Process Change Management

How does your organization handle changes to disclosure processes?

We have no formal process for managing changes to our disclosure procedures. We have basic change management procedures, but they may not be consistently followed or documented. We have established change management processes for most disclosure procedures, including impact assessments. We have comprehensive change management protocols that handle all process modifications, assess impacts, and ensure smooth transitions during implementation.

Issue Escalation and Resolution

How does your organization manage issues that arise in the disclosure process?

There is no formal process for identifying or resolving disclosure-related issues. Some issue-reporting processes exist, but resolution approaches are inconsistent and informal. We have established issue-reporting and resolution procedures, but they may not always be followed consistently across teams. Comprehensive protocols ensure efficient identification, reporting, and resolution of all disclosure-related issues.

Process Improvement Cycle

How does your organization approach continuous improvement of disclosure processes?

There is no formalized process for continuously improving disclosure procedures. We occasionally improve our disclosure processes, but not as part of a systematic approach. We periodically review and refine disclosure processes, but improvements are not consistently implemented across all areas. Continuous analysis and refinement of all disclosure processes are driven by feedback and performance metrics, enhancing operational efficiency.

Process Monitoring

How does your organization monitor disclosure processes for potential risks?

There are no formal monitoring processes for our disclosure activities. Basic monitoring of a few key processes is in place but does not cover all activities and may not be reviewed regularly. We monitor most disclosure processes, but some areas may not be covered comprehensively or reviewed consistently. We systematically identify potential risks, evaluate their impact, and implement controls to minimize adverse effects across all disclosure processes.

Process Performance Metrics

How does your organization use metrics to evaluate and improve disclosure processes?

No formal metrics are used to evaluate the performance of disclosure processes. We track basic performance metrics, but they are not consistently analyzed or used for improvement. Metrics are tracked for most disclosure processes, though they may not always be used effectively for process improvement. Comprehensive key performance indicators (KPIs) are applied across all disclosure processes, continuously analyzed to evaluate efficiency and drive ongoing improvements.

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Quality and Compliance

Quality Management System (QMS)

How would you characterize your organization's quality management system (QMS) for clinical trial disclosure?

We do not have a formal QMS. Quality-related documents are either absent, outdated or do not address disclosure-related processes. We have basic quality documents related to disclosure, but our QMS is not fully aligned with current practices, and quality principles are recognized but not fully integrated into daily operations. Our QMS includes quality objectives and guidelines covering most aspects of clinical trial disclosure, but it may not be fully comprehensive or updated regularly. We have a comprehensive, integrated QMS that includes a clear transparency policy, well-defined quality objectives, and mechanisms for continuous improvement. The system is regularly reviewed and updated.

Compliance Monitoring/Auditing and Quality Control

How does your organization approach compliance monitoring, auditing, and quality control for clinical trial disclosure?

We do not have a formal compliance-monitoring system. Quality checks are inconsistent and typically only performed in response to identified issues. Basic monitoring and auditing processes are in place, but they may not cover all critical aspects of disclosure. We have established compliance-monitoring and auditing processes, with quality control measures covering the most critical aspects of disclosure. We have a proactive, risk-based compliance-monitoring system with regular audits and comprehensive quality control integrated throughout the disclosure process.

Regulatory Intelligence

How does your organization manage regulatory intelligence for clinical trial disclosure?

We do not have a systematic process for monitoring regulatory changes or assessing their impact on quality and compliance. Basic processes exist to discover and track significant regulatory changes in key markets such as the US, EU, and Japan. However, these do not cover all countries where we conduct trials. We monitor regulatory changes in most key markets and integrate these changes with our quality management system. We have robust systems that proactively monitor global regulatory landscapes, and we seamlessly integrate new requirements into our quality management and compliance processes.

CAPA Management

How does your organization handle corrective and preventive actions (CAPA) for clinical trial disclosure?

We do not have a formal CAPA process for clinical trial disclosure issues. We have a basic CAPA process, but it may not be fully documented or consistently applied across all disclosure-related issues. We have a structured CAPA process that covers most disclosure-related issues, with root cause analysis and preventive measures in place. We implement a systematic CAPA process, identifying root causes, correcting issues, and preventing recurrence through full documentation and follow-up.

Incident Management

How does your organization manage incidents and deviations in the clinical trial disclosure process?

We do not have formal procedures for reporting or managing disclosure-related incidents. We have basic incident-reporting procedures, but investigation and resolution processes may not be consistently applied. We have established procedures for reporting and investigating most disclosure-related incidents, with some resolution tracking. We have comprehensive procedures for reporting, investigating, and resolving all deviations and incidents in the disclosure process, with clear accountability and follow-up.

Risk Management

How does your organization approach risk management in clinical trial disclosure?

We do not have a formal risk-management process for disclosure activities. We conduct basic risk assessments for some disclosure activities, but they may not be comprehensive or regularly updated. We have a structured risk-management process covering most disclosure activities, with some mitigation strategies in place. We proactively identify, assess, and mitigate potential disclosure quality and compliance risks through comprehensive strategies that are regularly reviewed and updated.

Audit Readiness

How prepared is your organization for regulatory inspections and audits related to clinical trial disclosure?

We do not have specific preparations for disclosure-related audits or inspections. We have basic audit preparation processes, but they may not cover all aspects of disclosure or be regularly updated. We have established and tested audit readiness procedures covering most aspects of disclosure. We have comprehensive audit readiness procedures that ensure continuous preparedness for regulatory inspections and audits related to clinical trial disclosure.

Quality Metrics

How does your organization use metrics to evaluate and improve quality and compliance in clinical trial disclosure?

We do not use formal metrics to evaluate our disclosure quality and compliance. We track basic metrics for some disclosure activities but results may not be consistently analyzed or used for improvement. We track and analyze metrics for most aspects of disclosure, using them to drive some process improvements. We have comprehensive quality metrics in place, which are continuously analyzed and used to drive improvements across all aspects of disclosure.

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Technology and Systems

Dedicated Clinical Trial Disclosure Systems

How would you characterize your organization's clinical trial disclosure system?

We have no dedicated disclosure system. We rely on manual processes and general-purpose tools like spreadsheets. We have a basic disclosure management system, but it is not fully utilized across the organization or lacks key features. We use a disclosure system for most activities, but some processes remain manual, and full integration is lacking. We use a comprehensive, fully integrated disclosure management system with advanced features such as automation, compliance tracking, and real-time reporting.

System Integration

How well are your disclosure systems integrated with other clinical trial management tools?

Our systems are not integrated, and manual data transfer (copy/paste) is required among platforms. Some integration among systems exists but is limited and requires frequent manual intervention. We have significant integration among most of our systems, with some automated data transfer. All relevant systems are seamlessly integrated, with real-time data synchronization, reducing manual effort and enhancing accuracy.

Workflow & Task Management Tools

How does your organization manage workflows and tasks for clinical trial disclosure?

We do not have formal workflow tools, and tasks are managed manually through basic tools like email, spreadsheets, and calendars. We have basic workflow management in place, but it may lack advanced features or full adoption. We use workflow tools that automate most task assignments and track progress, but not all tasks are fully optimized or automated. Sophisticated workflow tools are used across all disclosure processes, automating task assignments, progress tracking, and ensuring timely completion.

Security Controls

How robust are your security measures for clinical trial disclosure systems?

We have minimal or no security controls specifically related to clinical trial disclosure systems. Basic security controls are in place but may not cover all systems or be regularly updated. Security controls are established and cover most aspects of our disclosure systems, but some gaps may remain in access management or monitoring. Comprehensive security controls are in place, protecting sensitive information, managing access permissions, and monitoring system activity with detailed audit trails.

User Support

How does your organization provide support for users of clinical trial disclosure systems?

We have no formal user-support process for our disclosure systems. We offer basic user support, but it may not be comprehensive or consistently available. We have established user-support processes covering most aspects of our disclosure systems. We have comprehensive processes for keeping users proficient, addressing issues, maintaining system health, and implementing improvements.

Disaster Recovery

How prepared is your organization for potential disruptions to clinical trial disclosure systems?

We have no formal disaster recovery plan for our disclosure systems. A basic disaster recovery plan is in place, but it may not cover all critical systems or be tested regularly. A structured disaster recovery plan covers most systems, with periodic testing to ensure preparedness. A comprehensive disaster recovery plan covers all critical systems, with regular testing and continuous updates to address emerging risks.

AI/ML Capabilities

To what extent does your organization utilize AI/ML in clinical trial disclosure processes?

We have not explored the use of AI/ML capabilities for clinical trial disclosure. We are exploring the potential for AI/ML in our disclosure processes but have not yet implemented any solutions. AI/ML technologies are applied to automate select disclosure tasks, but their usage is not fully integrated into all processes. Advanced AI/ML capabilities are used to automate complex disclosure tasks, predict outcomes, and improve decision-making across all processes.

Innovation Planning

How does your organization approach innovation planning for clinical trial disclosure technologies?

We do not have a formal process for planning future technological needs in disclosure. We occasionally discuss future technology needs, but without a structured approach. We have a process for regularly reviewing and planning for future technological needs in disclosure. We plan strategically for future technological needs and actively pursue adopting emerging technologies to improve disclosure processes.

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Operating Model & Governance

Policies/SOPs/Disclosure Strategy

Which of the following best characterizes your organization's approach to policies, SOPs, and disclosure strategy for clinical trial transparency?

Our policies, strategies, and SOPs are not disclosure-specific or are out of date. Our transparency policy and disclosure SOPs only cover the US and EU requirements. We don't have a defined disclosure strategy. Our transparency policy and disclosure SOPs only cover the US and EU requirements. We have a defined disclosure strategy. Our transparency policy and disclosure SOPs address global trial disclosure and data sharing. We have a defined disclosure strategy, and a summary of our transparency policy is publicly available.

Organizational Alignment

How would you describe your company's organizational alignment for clinical trial disclosure?

Disclosure responsibilities are assigned to individuals with limited expertise, often struggling to gain support from clinical teams and executive management. A designated individual or small team oversees disclosure activities but may lack comprehensive organizational support or sufficient resources. We have a dedicated disclosure team or clearly defined disclosure roles, with growing cross-functional collaboration and support. We have a clear governance structure with well-defined oversight roles and decision-making processes for disclosure activities across the organization, including effective coordination with affiliates, CROs, and specialized disclosure service providers.

Regulatory Monitoring

How does your organization approach regulatory monitoring for clinical trial disclosure?

We have no formal process for monitoring regulatory changes. Awareness of new requirements is often reactive or delayed. We track significant regulatory changes in key markets but may not always interpret or implement them promptly. We track regulatory changes across most jurisdictions and integrate these changes into our governance processes, though not always proactively. We have robust systems that proactively monitor global regulatory landscapes and rapidly integrate changes into organizational processes.

Governance Structure

Which statement best describes your organization's governance structure for clinical trial disclosure?

We have no formal governance structure for disclosure. Responsibilities are unclear or fragmented. A governance structure is in place but lacks full transparency in decision-making, and buy-in from all departments is inconsistent. We have an established governance structure with defined roles, but some decision-making processes remain unclear or inconsistently followed. A comprehensive governance structure with clearly defined roles, responsibilities, and decision-making processes is regularly optimized to ensure efficiency.

Leadership Engagement

How would you characterize leadership involvement in clinical trial disclosure and transparency in your organization?

Leadership is primarily focused on strategic operational and commercial priorities. Clinical trial disclosure is managed at the departmental level. Leadership acknowledges the importance of clinical trial disclosure and transparency, with some involvement in key decisions and processes. Leadership is committed to clinical trial disclosure, regularly engaging in discussions and supporting significant initiatives. Leadership champions clinical trial disclosure, actively promoting a culture of openness and transparency.

Strategic Improvement Initiatives

How does your organization approach strategic improvement initiatives for clinical trial disclosure?

We do not have formal strategic improvement initiatives for clinical trial disclosure. We have identified some areas for improvement in our disclosure processes, but initiatives are ad hoc and not part of a broader strategy. We have implemented several strategic improvement initiatives for clinical trial disclosure aligned with short-term organizational goals. We have comprehensive, organization-wide programs to enhance the overall effectiveness and compliance of clinical trial disclosure, fully aligned with long-term strategic goals.

Resource Allocation & Budgeting

How would you describe your organization's approach to resource allocation and budgeting for clinical trial disclosure activities?

Resources for disclosure activities are allocated as needed but without dedicated budgeting. Resource allocation is reactive, and funding for disclosure activities is inconsistent across projects. Disclosure resources are allocated based on project needs, but long-term planning and prioritization are not fully integrated. Resource allocation is fully aligned with strategic priorities, with sufficient resources to meet all disclosure-related activities.

Vendor & Partner Management

How does your organization manage vendors and partners involved in clinical trial disclosure?

We have limited oversight of external parties involved in disclosure activities, with minimal formal management processes. We manage vendors for disclosure activities, but processes are inconsistent, and oversight is limited. Vendor and partner management is structured, but communication and coordination may present challenges across jurisdictions. We have a structured, proactive approach to managing vendors and partners, ensuring seamless coordination and clear oversight.

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Data Governance

Data Governance Framework

How would you characterize your organization's data governance framework for clinical trial disclosure?

No formal data governance framework exists. Data management practices are ad hoc and inconsistent across the organization. Basic data governance policies are in place, but implementation may be inconsistent, and some roles are not fully defined. We have an established data governance framework with defined roles and responsibilities, though some areas may not be consistently followed. A comprehensive, well-documented data governance framework is consistently applied across all disclosure activities. Regular reviews and updates ensure the framework remains effective and aligned with best practices.

Data Validation

How does your organization approach data validation for clinical trial disclosure?

Data validation is minimal or ad hoc, relying primarily on manual checks. There are no standardized validation processes across different datasets or disclosure activities. Basic automated validation checks are in place for key data elements, though processes may not cover all datasets. Automated validation processes cover most key datasets, complemented by occasional manual checks for specific critical data points. Data validation rules are updated periodically. Robust, automated data validation processes are implemented across all disclosure activities, supported by regular manual reviews and continuous improvement.

Data Ownership

How are data ownership and stewardship managed in your organization's clinical trial disclosure processes?

Data ownership is unclear or undefined. There is little accountability for data quality or management across the disclosure process. Basic data ownership roles are defined, but processes for correcting source-data issues are inconsistent. We have structured data ownership roles across most disclosure areas, with defined processes for issue resolution, though there may still be gaps. Clear data ownership and stewardship roles are established across the organization, ensuring accountability, issue resolution, and ongoing improvements.

Data Organization

How does your organization structure data for clinical trial disclosure?

Our datasets are not consistently organized. Different departments may use varying structures or formats. We have basic data organization principles, but they may not be applied consistently across all systems or departments. We have a structured approach to data organization for most of our clinical trial disclosure data, but some inconsistencies may exist. Our data are consistently structured for optimal use and integration across all systems involved in clinical trial disclosure.

Data Harmonization

To what extent is data harmonized across different sources and registries in your clinical trial disclosure processes?

We have no formal data-harmonization processes. Data definitions and formats may vary significantly across sources. We have basic data-harmonization efforts, but inconsistencies exist across many data sources and registries. We have harmonized data definitions and formats for most key data elements, but some inconsistencies remain. We ensure complete consistency in data definitions and formats across all sources and registries involved in clinical trial disclosure.

Data Security

How does your organization approach data security for clinical trial disclosure information?

We have minimal security measures for our clinical trial disclosure data. Basic security measures exist, but coverage may not extend to all disclosure systems or datasets. We have implemented security controls covering most disclosure datasets and processes, though some elements may require manual oversight. We have robust measures to protect all clinical trial disclosure data from unauthorized access, breaches, and loss, with regular security audits and updates.

Access Management

How does your organization manage access to clinical trial disclosure data?

We have no formal access-management process. Data access is not consistently controlled or monitored. We have basic access controls, but they may not be comprehensive or regularly updated. We have defined access controls based on roles and responsibilities for most of our disclosure data, with some monitoring in place. We have comprehensive controls and data access monitoring based on clearly defined roles and responsibilities, with regular audits and updates.

Records Management

How does your organization manage records related to clinical trial disclosure?

We have no formal records-management process for clinical trial disclosure. We have basic records-management practices, but they may not be comprehensive or consistently applied. We have established records-management processes for most aspects of clinical trial disclosure, but some gaps may exist. We have comprehensive processes for organizing and maintaining all clinical trial records throughout their lifecycle, with regular audits and improvements.

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Reporting & Metrics

Key Performance Indicators

How would you characterize your organization's use of KPIs for clinical trial disclosure?

Few or no KPIs are defined for disclosure activities, and performance measurement is ad hoc and inconsistent. Basic KPIs are established, primarily focusing on compliance rates and timeliness, but they may not cover all aspects of disclosure performance. KPIs cover most aspects of compliance and quality, with some additional focus on efficiency, though they may not always be regularly reviewed or fully optimized. Comprehensive KPIs cover compliance, quality, efficiency, and stakeholder satisfaction. KPIs are regularly reviewed, updated, and aligned with organizational goals and evolving regulatory requirements.

Metrics and Reports

How does your organization approach metrics and reporting for clinical trial disclosure?

There is minimal reporting, often limited to basic compliance statistics. Reports are generated manually and infrequently. We produce regular reports covering key compliance metrics, but these reports may lack depth or context and are only partially automated. Reports are generated regularly, with some automation covering the most critical metrics. However, the analysis may not always be comprehensive or predictive. A fully automated reporting system generates real-time dashboards and in-depth analytical reports tailored to stakeholder needs. Predictive analytics are used to anticipate future challenges and trends.

Data Sources

How does your organization manage data sources for clinical trial disclosure reporting?

Data are collected from disparate sources with little validation. Data integrity issues are common and often undetected. Primary data sources for reporting are identified, with basic validation processes in place, but data discrepancies may still occur. Most key data sources are integrated and validated, though a unified data management approach is not fully established. A comprehensive data-governance framework ensures data integrity, with automated systems integrating multiple data sources and robust validation and reconciliation processes in place.

Trend Analysis & Root Cause Analysis

How does your organization approach trend analysis and root cause analysis (RCA) for clinical trial disclosure performance?

We do not conduct regular trend or root cause analyses for disclosure performance. We occasionally examine trends in disclosure performance, but RCA is infrequent or inconsistent. We regularly analyze trends in disclosure performance and conduct RCA for major issues, but the process may not be systematic for all deviations. We systematically examine disclosure performance trends and investigate underlying causes for all significant deviations or issues, using the insights to drive continuous improvement.

Disclosure Performance Scorecard

Does your organization use a disclosure performance scorecard?

We do not have a disclosure performance scorecard. We have a basic scorecard that includes some key metrics, but it may not be comprehensive or regularly updated. We have a comprehensive scorecard, updated periodically, covering most aspects of disclosure performance. We maintain a consolidated, dynamic scorecard that provides an at-a-glance assessment of overall disclosure performance, regularly updated and aligned with organizational goals.

Reporting Automation and Integration

To what extent are your reporting processes automated and integrated with other clinical systems?

Our reporting processes are largely manual, with little or no automation or integration. We have some basic automation in our reporting processes, but integration with other systems is limited. We have significant automation in our reporting processes and some integration with other clinical systems. We use advanced technology to fully automate data collection, analysis, and report generation, seamlessly integrating with other clinical systems.

Benchmarking

How does your organization use benchmarking in clinical trial disclosure reporting?

We do not conduct benchmarking for our disclosure performance. We occasionally compare our performance to industry standards, but this is not a regular or systematic process. We regularly benchmark our disclosure performance against industry standards but may not compare against peer organizations. We systematically compare our disclosure performance against industry standards and peer organizations, using the insights to identify and implement improvements.

Stakeholder Feedback & Satisfaction

How does your organization collect and use stakeholder feedback on clinical trial disclosure processes and outputs?

We do not systematically collect or analyze stakeholder feedback on our disclosure processes or outputs. We occasionally collect feedback from internal stakeholders, but this is not a regular process and may not include external stakeholders. We regularly collect feedback from internal stakeholders and sometimes from external stakeholders, using some of this input to improve our processes. We systematically collect and analyze feedback from both internal and external stakeholders on our disclosure processes and outputs, using this information to drive continuous improvement.

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Training & Awareness

Training Programs

How would you characterize your organization's training programs for clinical trial disclosure?

Training is sporadic and limited in scope, often reactive to compliance issues. No structured program exists. A core training program covering the main regulatory requirements is in place, but updates may be infrequent. Some role-specific training may be available. We have a comprehensive training program covering most aspects of disclosure, though it may not be regularly updated or include practical exercises/examples. A comprehensive, role-specific training program is maintained and regularly updated. It includes practical exercises, assessments, and continuous improvement based on feedback and evolving need.

Competency Assessment

How does your organization assess competency in clinical trial disclosure activities?

No formal competency assessment exists for disclosure activities. Skills gaps are identified reactively when issues arise. Infrequent assessments are conducted, focusing primarily on regulatory knowledge. The results may be used to improve training and manage access to clinical trial disclosure systems. Regular competency assessments cover most disclosure activities, but they may not be fully integrated into our learning management system. Competency assessments are incorporated into the learning management system. Disclosure software users must show competency before being authorized to work in the system, and assessment results are used to tailor training programs.

Awareness Campaigns

How does your organization promote awareness about clinical trial disclosure across the organization?

Little to no effort exists to raise awareness about disclosure importance beyond the immediate disclosure team. Occasional awareness initiatives, such as emails or presentations, exist but are not part of a standard process. Regular awareness initiatives are conducted but may not be tailored to different stakeholder groups or use multiple communication channels. Ongoing multichannel awareness campaigns are tailored to different stakeholder groups. Proactive engagement with corporate communications, investor relations teams, and publications helps coordinate disclosure activities.

Compliance Education

How does your organization approach compliance education for clinical trial disclosure?

Compliance education is minimal or non-existent. Staff learn about requirements on an ad-hoc basis. Basic compliance training is provided, focusing on key regulatory requirements, but it may not cover all aspects or consequences of noncompliance. Comprehensive compliance education is provided, covering most regulatory requirements and consequences of noncompliance, but it may not be regularly updated. Focused, regularly updated training on all relevant regulatory requirements and the consequences of noncompliance, with practical examples and case studies, is provided.

Technology Adoption Training

How does your organization provide training on disclosure-related systems and tools?

Little to no specific training is provided for disclosure-related systems and tools. Users learn through trial and error. Basic training on core disclosure systems is provided, but it may not cover all tools or advanced features. Comprehensive training on most disclosure-related systems and tools is provided, but it may not be regularly updated or include hands-on practice. Specialized, regularly updated training is provided on all disclosure-related systems and tools, including hands-on practice sessions and advanced feature training to maximize their effective use.

Stakeholder Communication

How does your organization communicate with stakeholders about clinical trial disclosure processes and requirements?

There is minimal stakeholder communication about clinical trial disclosure processes and requirements. Basic information about disclosure requirements is shared with key stakeholders, but communication is infrequent or not comprehensive. Most stakeholders receive regular communication about disclosure processes and requirements, but this may not adequately address the importance of transparency or ensure ongoing support. Comprehensive initiatives inform all stakeholders about clinical trial disclosure processes, requirements, and the importance of transparency, ensuring ongoing support and participation in disclosure initiatives.

Knowledge Management

How does your organization manage and share knowledge related to clinical trial disclosure?

There are no formal systems or processes for capturing or sharing disclosure-related knowledge within the organization. Basic documentation of disclosure processes exists, but there's no systematic approach to knowledge sharing or maintenance. We have systems for capturing and sharing most disclosure-related knowledge, but they may not be consistently used or regularly updated. Comprehensive systems and processes are in place for capturing, sharing, and maintaining all disclosure-related knowledge within the organization, with regular updates and easy access for all relevant staff.

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Organization

Roles and Responsibilities

How well-defined are your organization's clinical trial disclosure roles and responsibilities?

Disclosure responsibilities are poorly defined, with significant overlap or gaps. Staff often struggle to understand their roles in the disclosure process. Basic role definitions exist, but areas of ambiguity remain. Some staff members clearly understand their responsibilities, while others are less certain. Most roles and responsibilities for disclosure activities are well-defined, though there may still be some gaps in cross-functional roles. Comprehensive, well-documented operational roles are defined for all disclosure tasks, including cross-functional collaboration and backup personnel. Regular reviews ensure alignment with organizational needs and regulatory requirements.

Organizational Structure

How would you characterize your company's organizational structure for clinical trial disclosure?

Disclosure responsibilities are scattered across the organization without a coherent structure. There is no clear leadership or strategic direction for disclosure activities. A basic disclosure function is in place, but it may lack sufficient resources or organizational support to fully meet the company's needs. The disclosure function is well-established and supported by key departments, though further integration with broader company strategy is needed. A well-resourced, strategically positioned disclosure function operates with clear reporting lines and strong executive support. The structure adapts readily to changing regulatory landscapes and organizational needs.

Cross-Functional Collaboration

How effective is cross-functional collaboration for clinical trial disclosure in your organization?

Departments operate in silos, with minimal communication on disclosure matters. Collaboration, when it occurs, is typically reactive and inefficient. Some departments have informal collaboration channels. Cooperation is improving but remains inconsistent across the organization. Cross-functional collaboration is established for most disclosure activities, but coordination across all departments is not fully optimized. A culture of proactive collaboration permeates all relevant departments. Well-established processes facilitate information sharing and joint decision-making, resulting in efficient and effective disclosure practices.

Internal-External Integration

How well does your organization coordinate clinical trial disclosure activities between internal teams and external partners?

There is minimal coordination between internal teams and external partners for disclosure activities. Practices are inconsistent and often lead to compliance issues. Basic coordination exists, but processes are not well-defined, leading to occasional inconsistencies or compliance risks. We have established processes for coordinating most disclosure activities with external partners, but inconsistencies may still occur. There is seamless coordination between internal teams and external partners (e.g., CROs, service providers, collaborators) to ensure consistent and compliant disclosure practices across all activities.

Global Coordination

How does your organization manage clinical trial disclosure activities across geographical regions and regulatory jurisdictions?

Disclosure activities are managed independently in regions with little or no coordination. There is some attempt to coordinate disclosure activities globally, but practices remain largely inconsistent across regions. We have established processes for coordinating disclosure activities across most regions, but inconsistencies or inefficiencies may still exist. Disclosure activities are fully harmonized across all geographical regions and regulatory jurisdictions, maintaining consistency and efficiency while adapting to local requirements.

Resource Allocation

How does your organization allocate resources for clinical trial disclosure activities?

Resource allocation for disclosure activities is ad hoc and often inadequate. Resources for disclosure activities are allocated reactively and may have inconsistent funding and staffing. Resources are allocated based on project needs, but the distribution may not be fully optimized for performance and regulatory compliance. Resource allocation is fully aligned with strategic priorities, with sufficient personnel and budget dedicated to meet all disclosure-related activities, supported by long-term planning.

Performance Management

How does your organization manage and improve performance in clinical trial disclosure roles?

There is no formal performance-management process for disclosure-related roles. Basic performance evaluations are conducted, but they may not focus specifically on disclosure activities or drive improvement. We have a performance-management process for most disclosure roles, but it may not be comprehensive or consistently applied. Individual and team performance in all disclosure-related roles is evaluated and improved on an ongoing basis, enhancing overall organizational effectiveness.

Organizational Change Management

How does your organization manage changes in clinical trial disclosure processes, regulations, or technologies?

Changes are implemented with little to no structured approach, often leading to disruption and resistance. There is a basic approach to managing changes, but it may not be comprehensive or consistently applied. We have a structured approach to managing most changes in disclosure processes, but it may not fully address all aspects of organizational adaptation. A comprehensive, structured approach is used to transition individuals, teams, and the organization to adapt to all changes in disclosure processes, regulations, or technologies.

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