The Association of Clinical Research Professionals
Competency Domains for Clinical Research Professionals
We are working to standardize the competence required of clinical research professionals through the multi-stakeholder Joint Task Force for Clinical Trial Competency.
By establishing a broadly supported set of competencies in core domains, we aim to lead standardization in the clinical trial workforce and support its ongoing development through competence-based education and training.
Click the icons below to explore the Harmonized Core Competencies for Clinical Research Professionals developed by the Joint Task Force for Clinical Trial Competency
Clinical Trial Operations (GCPs)
Encompasses study management and GCP compliance; safety management (adverse event identification and reporting, postmarket surveillance, and pharmacovigilance), and handling of investigational product.
Evaluate the conduct and management of clinical trials within the context of a Clinical Development Plan
Describe the roles and responsibilities of the clinical investigation team as defined by GCP guidelines
Evaluate the design conduct and documentation of clinical trials as required for compliance with GCP guidelines
Compare and contrast the regulations and guidelines of global regulatory bodies relating to the conduct of clinical trials
Describe appropriate control, storage, and dispensing of investigational products
Differentiate the types of adverse events (AEs) that occur during clinical trials, understand the identification process for AEs, and describe the reporting requirements to institutional review boards/independent ethics committees (IRBs/IECs), sponsors, and regulatory authorities
Describe how global regulations and guidelines assure human subject protection and privacy during the conduct of clinical trials
Describe the reporting requirements of global regulatory bodies relating to clinical trial conduct
Describe the role and process for monitoring of the study
Describe the roles and purpose of clinical trial audits
Describe the safety reporting requirements of regulatory agencies both pre- and post-approval
Describe the various methods by which safety issues are identified and managed during the development and postmarketing phases of clinical research
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 component parts of a traditional scientific publication
Effectively communicate the content and relevance of clinical research findings to colleagues, advocacy groups, and the nonscientist community
Describe methods necessary to work effectively with multidisciplinary teams
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 that biostatistics and informatics serve in biomedical and public health research
Describe the typical flow of data throughout a clinical trial
Summarize the process of electronic data capture and the importance of information technology in data collection, capture, and management
Describe the ICH GCP requirements for data correction and queries
Describe the significance of data quality assurance systems and how standard operating procedures are used to guide these processes
Ethical and Participant Safety Considerations
Encompasses care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial.
Compare and contrast clinical care and clinical management of research participants
Define the concepts of “clinical equipoise” and “therapeutic misconception” as related to the conduct of a clinical trial
Compare the requirements for human subject protections and privacy under different national and international regulations and ensure their implementation throughout all phases 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 ensuring the protection of human participants in clinical research
Describe the ethical issues involved when dealing with vulnerable populations and the need for additional safeguards
Evaluate and apply an understanding of the past and current ethical issues, cultural variations, and commercial aspects to the medicines development process
Explain how inclusion and exclusion 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 trial subjects
Leadership and Professionalism
Encompasses the principles and practice of leadership and professionalism in clinical research
Describe the principles and practices of leadership, management, and mentorship, and apply them within the working environment
Identify and implement procedures for the prevention or management of the ethical and professional conflicts that are associated with the conduct of clinical research
Identify and apply the professional guidelines and codes of ethics that apply to the conduct of clinical research
Describe the effect of cultural diversity and the need for cultural comp
Medicines Development and Regulation
Encompasses knowledge of how drugs, devices, and biologicals are developed and regulated.
Discuss the historical events that precipitated the development of governmental regulatory processes for drugs, devices, and biologics
Describe the roles and responsibilities of the various institutions participating in the medicines development process
Explain the medicines development process and the activities that integrate commercial realities into the life cycle management of medical products
Summarize the legislative and regulatory framework that supports the development and registration of medicines, devices, and biologics and ensures their safety, efficacy, and quality
Describe the specific processes and phases that must be followed in order for the regulatory authority to approve the marketing authorization for a medical product
Describe the safety reporting requirements of regulatory agencies both pre- and post-approval
Appraise the issues generated and the effects of global expansion on the approval and regulation of medical products
Scientific Concepts and Research Design
Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials.
Demonstrate knowledge of pathophysiology, pharmacology, and toxicology as related to medicines discovery and development
Identify clinically important questions that are potentially testable clinical research hypotheses, through review of the professional literature
Explain the elements (statistical, epidemiological, and operational) of clinical and translational study design
Design a clinical trial
Critically analyze study results with an understanding of therapeutic and comparative effectiveness
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 utilized to determine whether or not to sponsor, supervise, or participate in a clinical trial
Develop and manage the financial, timeline, and cross-disciplinary personnel resources necessary to conduct a clinical or translational research study
Apply management concepts and effective training methods to manage risk and improve quality in the conduct of a clinical research study
Utilize elements of project management related to organization of the study site to manage patient recruitment, complete procedures, and track progress
Identify the legal responsibilities, issues, liabilities, and accountabilities that are involved in the conduct of a clinical trial
Identify and explain the specific procedural, documentation, and oversight requirements of PIs, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial
In an attempt to bring together disparate, but high-quality efforts focused on clinical trial competence, a meeting of representatives from pharmaceutical companies, contract research organizations, academic institutions, clinical research sites, and professional societies was hosted by the Multi-Regional Clinical Trial (MRCT) Center at Harvard University during spring 2013. A broad-based and widely representative group was formed and named the Joint Task Force (JTF) for Clinical Trial Competency.
The members of the JTF agreed to work toward aligning and harmonizing the many focused statements relating to core competency for clinical research professionals into a single, high-level set of standards, which could be adopted globally and serve as a framework for defining professional competency throughout the clinical research enterprise. The JTF had a second face-to-face meeting in June 2013, which included participants from an even broader representation of the clinical research community.
The JTF then worked through the summer of 2013 and presented its final report in October of that year.
The process used by the JTF was designed to acknowledge and incorporate the inputs from the many participating organizations. It required a review of the many different competency statements and identification of competency domains, or broad categories of the knowledge, skills, and attitudes necessary to function within the field of clinical research. It determined that all of the competency statements could be aligned within the eight competency domains.
Contributors and Collaborators
Association of Clinical Research Professionals
Academy of Physicians in Clinical Reserch
Alliance for Clinical Research Excellence and Safety
Clinical & Translational Science Awards
Collaborative Institutional Training Initiative
Consortium of Academic Programs in Clinical Research
Drug Information Association
Global Health Network
Inter-American Foundation for Clinical Research
International Federation of Associations of Pharmaceutical Physicians
The Core Competency Framework can be used in many ways toward improving the quality and safety of the clinical research enterprise, such as to define certification criteria used by personnel or site certifying agencies. The framework also could be used to formulate accreditation standards for academic programs, both to standardize curricula and to ensure that programs are sufficiently comprehensive.
Ultimately though, the most effective method to improve clinical trials would be to ensure that those responsible for the various aspects of the clinical trial bring the appropriate competence at the appropriate time. The greater challenge is implementation of this conceptual framework into an operational model, and a good place to start could be the clinical research design, whereby a look at competencies across two different types of studies can reveal variability in requirements.
For instance, comparing an investigatorinitiated, observational trial to an industry-sponsored, premarket interventional trial illustrates how this framework might be used to qualify a PI. As depicted right, the competencies for the Study and Site Management Domain are identical in the two different styles of trial, but not so for the Scientific and Research Design Domain. This does not imply that a less competent investigator can perform an observational study, but that a lower level of competency is required for that study method. Furthermore, the level of competency might be quite different for other clinical research team roles, such as CRC, CRA, data manager, or regulatory affairs coordinator.
Once the necessary competency is defined, the PI, study sponsor, and interested regulatory authority must ensure that the study team member possesses the necessary competencies to carry out the selected, protocol-defined tasks. If additional knowledge or skills are needed, this would be the proper place to integrate with training programs that have training materials and processes that are harmonized to the protocol-specific competency requirements.
The information presented here is from an article, “Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional,” published in the June 2014 issue of Clinical Researcher and authored by:
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