About-cancer/treatment/clinical-trials/what-are-trials/team

Research Team Members

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 (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