Table 1

Areas of expertise required for the clinical investigator.

Ability to formulate clinical research topics that focus on important, testable questions
Ability to review and synthesize the literature
Ability to design feasible research studies to address the questions
Ability to implement research protocols
Ability to recognize and avoid sources of error
Ability to manage large volumes of clinical data
• acquisition
• storage
• quality control
Ability to appropriately analyze, interpret, and report research results
Knowledge about ethical and regulatory issues, including but not limited to
• informed consent
• protection of vulnerable research populations
• adverse event monitoring and reporting
• compliance with research billing
• conflicts of interest
• standards of authorship