Designing and running a clinical trial requires the skills of many experts. Each team may be set up differently at different sites. Typical team members and their duties 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 (IRB) 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 health care 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
