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DOMAIN 7: Leadership and Professionalism

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


7.1

Describe and apply the principles and practices of leadership, management and mentorship in clinical research.

Fundamental Level:

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.

Skilled Level:

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.

Advanced Level:

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.


7.2

Identify ethical and professional conflicts associated with the conduct of clinical studies and implement procedures for their prevention or management.

Fundamental Level:

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Example: Describes how the concepts within historical documents (e.g., of the Nuremburg Code, the Declaration of Helsinki, the Belmont Report and the CIOMS International Ethical Guidelines for Research Involving Human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.

Skilled Level:

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.

Advanced Level:

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.


Fundamental Level:

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.

Skilled Level:

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.

Advanced Level:

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)

7.3

Identify and apply the professional guidelines and codes of ethics that apply to the conduct of clinical research.


Fundamental Level:

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

Skilled Level:

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.

Advanced Level:

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.

7.4

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