Glossary of Terms
Families often have a lot of questions when considering whether or not to enroll themselves or their child in a clinical study. Below are some common terms about clinical studies and research at Children's Medical Center. We hope the definitions help as you gather information.
Coordinator or Study Coordinator - An individual who assists the investigators by carrying out some of the study operations. The Study Coordinator's duties may include obtaining informed consent, scheduling visits, communicating with the IRB, maintaining the study records, and performing some of the study procedures. The Principal Investigator is responsible for supervising all of the activities performed by the Study Coordinator.
Clinical Research - A study that involves a human subject. Clinical Research differs from regular medical care. In medical care, a patient's doctor can choose the timing and selection of diagnostic tests, procedures, and treatments. In clinical research, the Investigator and Subject don't choose; the care is dictated by the research Protocol.
Intervention - The drug, diet, vaccine, psychological care, or device that is the subject of the research. Participants can be assigned to treatment groups or everyone might get the same treatment depending on the study design.
Investigator or Researcher - An individual conducting a research study. The Principal Investigator (PI) is the person responsible for the overall conduct of the study. The PI may be assisted by one or more co-investigators and Study Coordinators.
IRB or Institutional Review Board - The IRB is the hospital's research ethics committee. The members of the IRB have expertise in scientific areas, the conduct of research, research ethics, federal and state laws that govern research and at Children’s, the issues of importance to understanding children and their development. The IRB is made up of individuals who are independent of the research study. The job of the IRB is to protect the rights and welfare of study participants.
Observation - Measurements made to follow research participants; the measurements couldinclude things like blood tests, x-Rays, physical exams, and questionnaires. Some studies don't involve any interventions; instead of assigning people to treatment groups, the researchers just see how people with different health conditions do over time.
Protocol - The detailed description of the research study. This includes the following information:
- background explaining why the study should be conducted;
- discussion of the design of the study
- description of who is allow to take part;
- information about study drugs or treatments
- detailed list of all of the study visits and the procedures associated with each visit; and
- plan for data management, analysis and sample size justification;
- safety management plan - adverse events and study monitoring;
- discussion of pertinent ethical issues;
- key references.
Research - An Experiment or Study.
Subject or Participant - A person who is taking part in a clinical research study. Participants can be healthy individuals or patients who have with a disease or condition. A patient gets to make their own care choices with the advice and prescription of their doctor; subjects follow the care prescribed in the research protocol.