The Association of Clinical Research Professionals

Competency Domains for Clinical Research Professionals

The Core Competency Framework for Clinical Research Professionals is designed to standardize competency expectations for the clinical research workforce by defining the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical trials.

Developed by the Joint Task Force for Clinical Trial Competency — an international team of investigators, educators, and other stakeholders, including ACRP — the framework focuses on eight core competency domains, including Scientific Concepts and Research Design, Ethical and Patient Safety Considerations, Investigational Products Development and Regulation, Clinical Study Operations (Good Clinical Practice), Study and Site Management, Data Management and Informatics, Leadership and Professionalism, and Communications and Teamwork.

Explore each domain below (click to expand images), along with several ACRP-developed resources to help guide workforce development.

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

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

Investigational Products 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

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

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

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

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 impact of regional diversity and demonstrate cultural competency in clinical study design and conduct

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

ACRP Core Competency Guidelines for Clinical Research Coordinators™

These guidelines are intended to provide CRCs with the support they need while improving operational quality and trial outcomes for all stakeholders in the clinical research enterprise.

Learn More >

ACRP Core Competency Framework for Clinical Trial Monitoring™

Prepare for the future of clinical trial monitoring by understanding the core competencies required of individuals involved in clinical study monitoring.

Learn More >

ACRP Functional Competency Guidelines for PIs and Sub Investigators™

These guidelines provide a comprehensive set of practical guidelines and actionable steps to help set and keep PIs and sub-investigators on a path to success in clinical trials.

Learn More >

ACRP Partners Advancing the Clinical Research Workforce™

ACRP’s Partners Advancing the Clinical Research Workforce™ is a multi-stakeholder collaborative of clinical research industry leaders who are committed to building a diverse, research-ready clinical research workforce.

ACRP Learning Update

Competency Domains for Clinical Research Professionals

The Core Competency Framework for Clinical Research Professionals is designed to standardize competency expectations for the clinical research workforce by defining the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical trials.

Explore each domain below (click to expand images), along with several ACRP-developed resources to help guide workforce development.

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

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

Investigational Products 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

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

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

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

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 impact of regional diversity and demonstrate cultural competency in clinical study design and conduct

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

ACRP Core Competency Guidelines for Clinical Research Coordinators™

These guidelines are intended to provide CRCs with the support they need while improving operational quality and trial outcomes for all stakeholders in the clinical research enterprise.

Learn More >

ACRP Core Competency Framework for Clinical Trial Monitoring™

Prepare for the future of clinical trial monitoring by understanding the core competencies required of individuals involved in clinical study monitoring.

Learn More >

ACRP Functional Competency Guidelines for PIs and Sub Investigators™

These guidelines provide a comprehensive set of practical guidelines and actionable steps to help set and keep PIs and sub-investigators on a path to success in clinical trials.

Learn More >