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Learn About Clinical Trials

  • Updated: 11/02/2012

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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 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