Harmonized Core Competency Framework


The Harmonized Core Competency Framework identifies the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research. Learn more about the competency domains and statements below: 

 
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Domain 1: Scientific Concepts and research desigN

Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials

 
• Apply principles of biomedical science to investigational product discovery and development and health-related behavioral interventions
• Identify scientific questions that are potentially testable clinical research hypotheses, through review of the professional literature
• Identify the elements and explain the principles and processes of designing a clinical study
• Critically analyze clinical study results

 
 
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Domain 2: Ethical and participant safety considerations

Encompasses care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial

 
• Differentiate between standard of care and clinical study activities
• Define the concepts of “clinical equipoise” and “therapeutic misconception” as they relate to the conduct of a clinical study
• Apply relevant national and international principles of human subject protections and privacy throughout all stages of a clinical study
• Explain the evolution of the requirement for informed consent from research participants and the principles and content of the key documents that ensure the protection of human participants in clinical research
• Describe the ethical issues involved when dealing with vulnerable populations and what additional safeguards should be in place for those populations
• Evaluate and apply an understanding of the relevant ethical issues and cultural variation as it applies to the commercial aspects of the clinical research and investigational product development process
• Explain why inclusion, exclusion, and other criteria are included in a clinical protocol to assure human subject protection
• Summarize the principles and methods of distributing and balancing risk and benefit; through selection and management of clinical study subjects

 
 
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Domain 3: Investigational Products Development and regulation

Encompasses knowledge of how drugs are developed and regulated

 
• Discuss the historical events that precipitated the development of governmental regulatory processes for investigational products
• Explain the investigational products development process and the activities which integrate commercial realities into the life cycle management of medical products
• Explain the medicines development process and the activities which integrate commercial realities into the life cycle management of medical products
• Summarize the legislative and regulatory framework that supports the development and registration of investigational products and ensures their safety, efficacy and quality
• Describe the specific processes and phases that must be followed for the regulatory authority to approve the marketing authorization for a medical product
• Describe the pre- and post- approval safety reporting requirements of regulatory agencies
• Appraise the issues generated and the effects of global expansion on the approval and regulation of medical products


 
 
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Domain 4: Clinical study Operations (GCPs)

Encompasses study management and GCP compliance; safety management (adverse event identification and reporting, post-market surveillance, and pharmacovigilance), and handling of investigational product

 
• Explain how the design, purpose, and conduct of individual clinical studies fit into the goal of developing a new intervention
• Describe the roles and responsibilities of the clinical investigation team as defined by Good Clinical Practice Guidelines
• Evaluate the design conduct and documentation of clinical studies as required for compliance with Good Clinical Practice Guidelines
• Compare and contrast the regulations and guidelines of global regulatory bodies relating to the conduct of clinical studies
• Describe appropriate control, storage and dispensing of investigational product
• Differentiate the types of adverse events (AEs) that may occur during clinical studies and explain the identification process and reporting requirement to IRBs/IECs, sponsors and regulatory authorities
• Describe how global regulations and guidelines assure human subject protection and privacy during the conduct of clinical studies
• Describe the reporting requirements of global regulatory bodies relating to clinical study conduct
• Describe the role and process of monitoring a clinical study
• Describe the role and purpose of clinical study audits
• Describe the various methods by which safety issues are identified and managed in clinical studies


 
 
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Domain 5: Study and site management

Encompasses content required at the site level to run a study (financial and personnel aspects). Includes site and study operations (not encompassing regulatory/GCPs)

 
• Describe the methods used to determine whether to sponsor, supervise or participate in a clinical study
• Develop and manage the financial, timeline, and personnel resources necessary to conduct a clinical study
• Describe the management and training approaches to mitigate risk to improve clinical study conduct
• Develop strategies to manage participant recruitment, retention, compliance and track study activities.
• Identify the legal responsibilities, liabilities and accountabilities that are involved in the conduct of clinical studies
• Identify and explain the specific procedural, documentation and oversight requirements of principal investigators, sponsors, CROs and regulatory authorities that relate to the conduct of a clinical study

 
 
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Domain 6: Data Management and Informatics

Encompasses how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database

 
• Describe the role and importance of statistics and informatics in clinical studies
• Describe the origin, flow, and management of data through a clinical study
• Describe best practices and resources required for standardizing data collection, capture, management, analysis, and reporting
• Describe, develop, and implement processes for data quality assurance


 
 
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Domain 7: Leadership and Professionalism

Encompasses the principles and practice of leadership and professionalism in clinical research

 
• Describe and apply the principles and practices of leadership, management and mentorship in clinical research
• Identify ethical and professional conflicts associated with the conduct of clinical studies and implement procedures for their prevention or management.
• Identify and apply the professional guidelines and codes of ethics that apply to the conduct of clinical research
• Describe the impact of regional diversity and demonstrate cultural competency in clinical study design and conduct

 
 
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Domain 8: Communication and teamwork

Encompasses all elements of communication within the site and between the site and sponsor, CRO, and regulators. Understanding of teamwork skills necessary for conducting a clinical trial

 
• Discuss the relationship and appropriate communication between Sponsor, CRO and clinical research site
• Describe the components of a traditional scientific publication.
• Effectively communicate the content and relevance of clinical research findings to colleagues, advocacy groups and the non-scientist community
• Describe the importance of team science and methods necessary to work effectively with multidisciplinary and inter-professional research teams.