Glossary of Clinical Research - C

C

• Case report

A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin). (NCI)

• Case report form

A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. (ICH E6)

• Case series

A group or series of case reports involving patients who were given similar treatment. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (for example, age, gender, ethnic origin) and information on diagnosis, treatment, response to treatment, and follow-up after treatment. (NCI)

• Case-control study

A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that the other was not. Also called a retrospective study. (NCI)

• Clinical

Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. (NLM)

• Clinical investigation

Any experiment that involves a test article and one or more human subjects (21CFR50.3)

• Clinical investigator

A medical researcher in charge of carrying out a clinical trial's protocol. (NLM)

• Clinical practice guidelines

Guidelines developed to help health care professionals and patients make decisions about screening, prevention, or treatment of a specific health condition. (NCI)

• Clinical researcher

A health professional who works directly with patients, or uses data from patients, to do research on health and disease and to develop new treatments. Clinical researchers may also do research on how health care practices affect health and disease. (NCI)

• Clinical series

A case series in which the patients receive treatment in a clinic or other medical facility. (NCI)

• Clinical study or Clinical trial

• A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical trial. (NCI)
• A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NLM)
• Any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. (ICH E6)

• Clinical Trial/Study Report

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. (ICH E6)

• Clinician

A health professional who takes care of patients. (NCI)

• Cohort (statistics)

• A group of individuals who share a common trait, such as birth year. In medicine, a cohort is a group that is part of a clinical trial or study and is observed over a period of time. (NCI)
• In epidemiology, a group of individuals with some characteristics in common. (NLM)

• Cohort study

A research study that compares a particular outcome in groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke compared with those who do not smoke). (NCI)

• Community-based clinical trial (CBCT)

A clinical trial conducted primarily through primary-care physicians rather than academic research facilities. (NLM)

• Comparator

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. (ICH E6)

• Compassionate use

A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy. (NLM)

• Compassionate use trial

A way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial. (NCI)

• Complementary and alternative therapy

Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc. Internet Address: http://www.nccam.nih.gov. (NLM)

• Compliance

Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH E6)

• Confidentiality regarding trial participants

• Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained. (NLM)
• Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH E6)

• Consecutive case series

A clinical study that includes all eligible patients identified by the researchers during the study registration period. The patients are treated in the order in which they are identified. This type of study usually does not have a control group. (NCI)

• Content validity

The extent to which a variable (e.g. a rating scale) measures what it is supposed to measure. (ICH E9)

• Contract

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. (ICH E6)

• Contract Research Organization

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. (ICH E6)

• Contraindication

A specific circumstance when the use of certain treatments could be harmful. (NLM)

• Control

A control is the nature of the intervention control. (NLM)

• Control animal

An animal in a study that does not receive the treatment being tested. Comparing the health of control animals with the health of treated animals allows researchers to evaluate the effects of a treatment more accurately. (NCI)

• Control group

• In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works. (NCI)
• The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo (NLM)

• Controlled clinical trial

• A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. (NCI)
• An experiment or clinical trial that includes a comparison (control) group. (NCI)

• Controlled trials

Control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo. (NLM)

• Coordinating Committee

A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. (ICH E6)

• Coordinating Investigator

An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial. (ICH E6)