The CLR Program supports the advancement of integrated and interdisciplinary education, training, and career development in Clinical and Translational Science. The National Centers for Translational Science (NCATS), in collaboration with the CTSA Education and Career Development Key Function Committee, formed the Education Core Competency Work Group to define the training standards for core competencies in clinical and translational research. The work group’s final recommendations for core competencies include fourteen thematic areas that should shape the training experiences of junior investigators by defining the skills, attributes, and knowledge that can be shared across multidisciplinary teams of clinician-scientists. The Clinical Research Education Program has recently adopted these program competencies for all students.
The CLR Program uses these thematic competencies to guide overall program learning objectives, overall curriculum development, and course-specific learning objectives. Students will be expected to achieve proficiency in these thematic areas in the course of class work, seminars, journal club, independent study and through the Master’s Thesis and/or PhD dissertation. Attainment of these respective competencies will be assessed through the satisfactory completion of course work.
Core competencies in clinical, translational and patient-oriented research core thematic areas are outlined as follows:
Identify basic and preclinical studies that are potential testable clinical research hypotheses
Identify research observations that could be the basis of large clinical trials
Define the data that formulate research hypotheses
Derive translational questions from clinical research data
Prepare the background and significance sections of a research proposal
Critique clinical and translational research questions using date-based literature searches
Extract information from the scientific literature that yields scientific insight for research innovation
Conduct a comprehensive and systematic search of the literature using informatics techniques
Summarize evidence from the literature on a clinical problem
Describe the mechanism of a clinical problem reviewed in a manuscript
Use evidence as the basis of the critique and interpretation of results of published studies
Identify potential sources of bias and variations in published studies
Interpret published literature in a causal framework
Identify gaps in knowledge within a research problem
Formulate a well-defined clinical or translational research question to be studied in human or animal models
Propose study designs for addressing a clinical or translational research question
Assess the strengths and weaknesses of possible study designs for a given clinical or translational research question
Design a research study protocol
Identify a target population for a clinical or translational research project
Identify measures to be applied to a clinical or translational research project
Design a research data analysis plan
Determine resources needed to implement a clinical or translational research plan
Prepare and application to the IRB
Compare the feasibility, efficiency, and ability to derive unbiased inferences from different clinical and translational research study designs
Assess threats to internal validity in any planned or completed clinical or translational study, including selection bias, misclassification, and confounding
Incorporate regulatory precepts into the design of any clinical or translational study
Integrate elements of translational research into given study designs that could provide the basis for future research, such as the collection of biomedical specimens, nested studies, and the development of community-based interventions
Describe the concepts and implications of reliability and validity of study measurements
Evaluate the reliability and validity of measures
Assess threats to study validity (bias) including problems with sampling, recruitment, randomization, and comparability of study groups
Differentiate between the analytic problems that can be addressed with standard methods and those requiring input from biostatisticians and other scientific experts
Implement quality assurance systems with control procedures for data intake, management, and monitoring for different study designs
Assess data sources and data quality to answer specific clinical or translational research questions
Implement quality assurance and control procedures for different study designs and analysis
Describe the role that biostatistics serves in biomedical and public health research
Describe the basic principles and practical importance of random variation, systematic error, sampling error, measurement error, hypothesis testing, type I and type II errors, and confidence limits
Scrutinize the assumptions behind different statistical methods and their corresponding limitations
Generate simple descriptive and inferential statistics that fit the study design chosen and answer research question
Compute sample size, power, and precision for comparisons of two independent samples with respect to continuous and binary outcomes
Describe the uses of meta-analytic methods
Defend the significance of data and safety monitoring plans
Collaborate with biostatisticians in the design, conduct, and analyses of clinical and translational research
Evaluate computer output containing the results of statistical procedures and graphics
Explain the uses, importance, and limitations of early stopping rules in clinical trials
Describe and make use of best practices for developing research instruments and protocols and for communicating results of research that are appropriate to specific audiences and special populations, addressing literacy and numeracy, cultural attitudes, and special terminologies
Identify how structure and organization of information in a domain can impact researchers’ translational research foci through fundamental data categories and elements, terminologies and taxonomies, and ontologies
Discuss the fundamental principles and practices that address the ethical, legal, social, privacy, and security implications of biomedical and health informatics
Illustrate the nature of the contributions in consulting and/or collaborating with biomedical and health informaticians throughout the life cycle of individual clinical and translational research projects: use the terminology and principles of biomedical informatics to interact effectively with informaticians; discriminate among the different subdomains of biomedical informatics in order to identify the appropriate informatics consultant or collaborator; and enumerate the roles of biomedical informatics specialists in the design, development, and implementation of translational research projects
Describe the essential information generation, management, analysis, transformation, summarization, and visualization methods that apply to CTS data, such as: genomic, proteomic and other “-omics” data; clinical data; imaging data; consumer and patient-reported data; and population-level and environmental exposure data
Identify, retrieve, and manage biomedical and health science knowledge through literature searches using advanced search techniques (MeSH, PubMed, Google Scholar, etc.)
Explain the role of health information technology standards in the interoperability of research, clinical, and administrative information systems and on secondary use of data for clinical and translational science
Compare and contrast the organizational roles and principal responsibilities essential for access management, and governance of data related to clinical and translational science
Describe the essential functions of major research computer systems (e.g., clinical trials management systems, biospecimen management systems, research grant and finance management systems, and research services tracking systems) that are relevant to clinical and translational scientists
Describe the essential functions of the major clinical systems (e.g., EHR and its feeder systems, such as radiology and lab) that are relevant to clinical and translational scientists and the challenges to using these data for research
Utilize informatics-based tools in translational research including: locate relevant informatics tools; select appropriate informatics tools; and use those tools in research for managing and analyzing biomedical and health information
Clinical Research Ethics Competencies
Summarize the history of research abuses and the rational for creating codes, regulations, and systems for protecting participants in clinical research that requires community input
Critique a clinical or translational research proposal for risks to human subjects
Explain the special issues that arise in research with vulnerable participants and the need for additional safeguards
Determine the need for a risk-benefit ration that is in balance with the outcomes in clinical and translational research
Describe the elements of voluntary informed consent, including increasing knowledge about research, avoiding undue influence or coercion, and assuring the decision-making capacity of participants
Assure the need for privacy protection throughout all phases of a study
Assure the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research
Adhere to IRB application procedures
Explain how the structural arrangement of science and the research industry may influence the behavior of scientists and the production of scientific knowledge
Responsible Conduct of Research Competencies
Apply the main rules, guidelines, codes, and professional standards for the conduct of clinical and translational research
Adhere to the procedures to report unprofessional behavior by colleagues who engage in misconduct in research
Implement procedures for the identification, prevention, and management of financial, intellectual, and employment conflicts of interest
Apply the rules and professional standards that govern the data collection, sharing, and protection throughout all phases of clinical and translational research
Apply elements of voluntary informed consent, of fostering understanding of information about clinical research, and for avoiding undue influence or coercion, and taking into consideration the decision-making capacity of participants
Explain the need for privacy protection and best practices for protecting privacy throughout all phases of a study
Explain the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research
Explain the function of the IRB
Communicate clinical and translational research findings to different groups of individuals, including colleagues, students, the lay public and the media
Translate the implications of clinical and translational research findings for clinical practice, advocacy, and governmental groups
Write summaries of scientific information for use in the development of clinical health care policy
Translate clinical and translational research findings into national health strategies or guidelines for use by the general public
Explain the utility and mechanism of commercialization for clinical and translational research findings, the patent process, and technology transfer
Differentiate between cultural competency and cultural sensitivity principles
Recognize the demographic, geographic, and ethnographic features within communities and populations when designing a clinical study
Describe the relevance of cultural and population diversity in clinical research design
Describe cultural and social variation in standards of research integrity
Critique studies for evidence of health disparities, such as disproportional health effects on select populations (e.g. gender, age, ethnicity, race)
Build an interdisciplinary/intradisciplinary/multidisciplinary team that matches the objectives of the research problem
Manage an interdisciplinary team of scientists
Advocate for multiple points of view
Clarify language differences across disciplines
Demonstrate group decision-making techniques; manage conflict
Manage a clinical and/or translational research study
Work as a leader of a multidisciplinary research team
Manage a multidisciplinary team across its fiscal, personnel, regulatory compliance and problem-solving requirements
Maintain skills as mentor and mentee
Validate others as a mentor
Foster innovation and creativity
Apply principles of adult learning and competency-based instruction to educational activities
Provide clinical and translational science instruction to beginning scientists
Incorporate adult learning principles and mentoring strategies into interactions with beginning scientists and scholars in order to engage them in clinical and translational research
Develop strategies for overcoming the unique curricular challenges associated with merging scholars from diverse backgrounds
Examine the characteristics that bind people together as a community, including social ties, common perspectives or interests, and geography
Appraise the role of community engagement as a strategy for identifying community health issues, translating health research to communities and reducing health disparities
Summarize the principles and practices of the spectrum of community-engaged research
Analyze the ethical complexities of conducting community-engaged research
Specify how cultural and linguistic competence and health literacy have an impact on the conduct of community-engaged research