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
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