Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical...

Area of Science:

• Global Health Research
• Clinical Research Management
• Professional Development

Background:

• Capacity development in clinical research is hindered by unrecognized staff skills.
• Existing competency frameworks are often role- or setting-specific.
• An integrated approach is needed for diverse global health research roles.

Purpose of the Study:

• To propose a single, flexible competency framework for the entire global health research team.
• To recognize staff skills and facilitate role progression.
• To identify capacity strengthening needs and enhance research engagement.

Main Methods:

• Systematic analysis of existing competency frameworks and job descriptions.
• Involved 11 distinct, broad clinical research roles.
• Identified 50 key competencies across the study life cycle.

Main Results:

• Defined 50 key competencies applicable across various study designs, locations, and diseases.
• Competencies categorized into five main areas: Ethics, Quality and Risk Management; Study and Site Management; Research Operations; Scientific Thinking; and Professional Skills.
• A pilot framework and implementation tools are available.

Conclusions:

• The proposed framework offers a new mechanism for research skills development and career progression.
• It is adaptable to diverse clinical research settings globally.
• The framework has the potential to significantly impact staff engagement and capacity building in clinical research.