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.
A1. Display professionalism in the workplace, in attire, attitude, work-ethic and quality products
A2. Identify the leadership structure of the organization
A3. Locate, comprehend, and adhere to the standard operating procedures in the research department
A4. Demonstrate initiative and team cooperation in performing research duties
Example: Arrives at work on time, articulates information in a succinct and appropriate manner both verbally and in writing, and seeks guidance or directions where he/she has questions.
B1. Assist others with various aspects of study management using effective communication methods and documentation
B2. Train and mentor Fundamental Level staff
B3. Demonstrate effective time management and organizational skill when managing multiple research related projects
Example: Plans and conducts a protocol implementation meeting.
C1. Serve in leadership roles in the research department
C2. Train and mentor new staff members and team members.
C3. Manage multiple complex study operations
C4. Set strategic planning goals and objectives for study performance
Example: Manages study teams and develops budgets and assists with contracts for clinical research projects.
Identify ethical and professional conflicts associated with the conduct of clinical studies and implement procedures for their prevention or management.
A1. Explain the nature and historical instances of ethical and professional conflicts which occur in the conduct of clinical research
A2. Describe the procedures which are implemented to prevent ethical conflicts and support risk management strategies
Example: Describes how the concepts within historical documents (e.g., of the Nuremburg Code, the Declaration of Helsinki, the Belmont Report and the CIOMS International Ethical Guidelines for Research Involving Human Subjects) concerning research ethics are integrated into a clinical research protocol.
B1. Recognize, implement, and manage the procedures in a clinical research study which minimize the risks of ethical and professional conflicts
B2. Implement risk management strategies within their role responsibilities
Example: Organizes and implements the procedures (such as participant recruitment strategies and informed consent) which are included in a clinical research protocol that mitigate ethical and professional risks to clinical trial integrity and contributes to risk management planning for a study team.
C1. Assess the risk of ethical and professional conflicts inherent in a clinical study
C2. Develop strategies and policies to implement and manage risk of ethical and professional conflicts across a project team as well as functional domains
Example: Appraises the potential risks (both ethical and professional) inherent in the conduct of a clinical research study and develops the framework for risk management for a department or project team.
A1. Recognize the key documents which make up the foundation of the regulations that ensure clinical studies are conducted ethically and in a professional manner
A2. Identify and understand the meaning of ethical and professional behaviors found in both federal regulations and international guidelines addressing ethical conduct in clinical studies.
Example: Identifies the key regulations and guidelines in FDA and ICH documents that ensure ethical conduct in clinical studies.
B1. Apply professional and ethical regulations and international guidelines in each facet of clinical research
B2. Demonstrate through actions and documentation of tasks during the conduct of clinical research an understanding of how appropriate procedures and processes assure professional and ethical conduct throughout clinical research
Example: In day-to-day activities and tasks, demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures, regulations, and guidelines.
C1. Evaluate, and modify when required, internal policies and procedures to ensure that the organization’s code of ethical conduct is in compliance with local law/regulations and/or international guidelines
C2. Mentor (educate) and provide guidance to all study team and staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted within the bounds of ethical conduct.
Example: Ensures all local and global regulations and guidelines are reflected in standard operating procedures and processes by adapting any established procedures, processes, or workflows to reflect any new or updated regulations and/or guidelines (e.g. training documentation)
Identify and apply the professional guidelines and codes of ethics that apply to the conduct of clinical research.
A1. Describe why it is important to incorporate strategies that account for regional and cultural diversity in the conduct of clinical research
A2. Classify examples of potential impact that are related to diversity or cultural competency
Example: Suggests strategies to address diversity and cultural competence for a diverse set of potential participants in a clinical study, including age, ethnicity, race, and gender and religion
B1. Apply regional/country and cultural considerations during study design and conduct
B2. Incorporate the appropriate regulatory requirements during the implementation of multi-country trials
Example: Recognizes cultural and diversity issues when developing a research idea into a global clinical study.
C1. Develop specific strategies or methods for considering culture and region/country when designing and conducting studies in multiple regions/countries
C2. Validate that regulatory requirements are incorporated into the study design for multi-country trials
Example: Proposes specific strategies that can be employed in each region/country to ensure cultural and regional appropriateness when initiating a new clinical study.