Designing and running a clinical trial requires the skills of many different types of experts. Each team may be set up differently at different sites. Typical team members and their responsibilities include:

Principal investigator. Supervises all aspects of a clinical trial. This person:

  • develops the concept for the trial
  • writes the protocol
  • submits the protocol for the Institutional Review Board approval
  • directs the recruitment of patients
  • manages the informed consent process
  • supervises data collection, analysis, interpretation, and presentation

Research nurse. Manages the collection of data throughout the course of a clinical trial. This person:

  • educates staff, patients, and referring healthcare providers about the trial
  • communicates regularly with the principal investigator
  • assists the principal investigator with the informed consent process, study monitoring, quality assurance, audits, and data management and analysis

Data manager. Manages the collection of data throughout the course of a clinical trial. This person:

  • enters the data
  • works with the principal investigator and research nurse to identify what data will be tracked
  • provides data to monitoring agencies
  • prepares summaries for interim and final data analysis

Staff physician or nurse. Helps take care of the patients during a clinical trial. This person:

  • treats patients according to the clinical trial protocol
  • assesses and records how each patient responds to the treatment and the side effects they may have
  • works with the principal investigator and research nurse to report trends of how patients are doing on the treatment
  • manages each patient’s care

Reproduced with permission from NIH’s National Cancer Institute. NIH does not endorse or recommend any products, services, or information described or offered here by Healthline. Page last reviewed June 22, 2016.