Page 10 - Terminology-Clinical-Research

status of a patient or subject. including their toxicology, safety, pharmacodynamics,
and pharmacokinetics (ADME- absorption, distribution,
Clinical development plan: A document that describes metabolism, and excretion).
the collection of clinical studies that are to be performed in
sequence, or in parallel, with a particular active substance, Clinical protocol: See Protocol.
device, procedure, or treatment strategy, typically with
the intention of submitting them as part of an application Clinical Research Associate (CRA): Person employed
for a marketing authorization. Note: The plan should have by the study sponsor or clinical research coordinator to
appropriate decision points and allow modification as monitor a clinical trial at one or more participating sites.
knowledge accumulates. The CRA is responsible for ensuring all clinical studies are
conducted according to study protocol, within regulations
Clinical document architecture: Specification for the and ICH guidelines.
structure and semantics of “clinical documents” for the
purpose of exchange. Clinical research and development: The testing of a drug
compound in humans primarily done to determine its safety
Clinical document: A documentation of clinical and pharmacological effectiveness. Clinical development is
observations and services. Note: An electronic document done in phases, which progress from very tightly controlled
should incorporate the following characteristics: dosing of a small number of subjects to less tightly
persistence, stewardship, potential for authentication, controlled studies involving large numbers of patients.
wholeness, and human readability.
Clinical Research Associate (CRA): Person employed
Clinical efficacy: Power or capacity to produce a desired by a sponsor or by a contract research organization acting
effect (i.e., appropriate pharmacological activity in a on a sponsor’s behalf, who monitors the progress of
specified indication) in humans. investigator sites participating in a clinical study. At some
sites (primarily in academic settings), clinical research
Clinical encounter: Contact between subject/patient coordinators are called CRAs.
and healthcare practitioner/researcher, during which an
assessment or activity is performed. Contact may be Clinical Research Coordinator (CRC): Person who
physical or virtual. handles most of the administrative responsibilities of a
clinical trial on behalf of a site investigator, acts as liaison
Clinical genomics - clinical trials impact: Clinical between investigative site and sponsor, and reviews all
genomics is the application of large-scale, high throughput data and records before a monitor’s visit. Synonyms:
genomics technologies in clinical settings, such as clinical trial coordinator, study coordinator, research coordinator,
trials or primary care of patients. Clinical genomics clinical coordinator, research nurse, protocol nurse.
promises to allow a molecular understanding of disease
and drug response, with benefits in all areas of medicine. Clinical Research Organization (CRO): An organization
Note: Contributing to the growth of genomics, in 2005 that conducts all or some of the clinical research involved
the FDA issued guidelines for applications of genomics in in the drug or product development process on behalf of
drug development, with the stated hope that genomics will pharmaceutical research companies.
improve the safety and effectiveness of medicines. Given
this mandate, clinical genomics applications appear to have Clinical significance: Change in a subject’s clinical
crossed a threshold with the recent approval of several condition regarded as important whether or not due to
clinical genomics products. the test intervention. Note: Some statistically significant
changes (in blood tests, for example) have no clinical
Clinical investigation: See Clinical trial, Clinical study. significance. The criterion or criteria for clinical
Note: Increased usage of investigation or study in the US significance should be stated in the protocol. The term
rather than “trial,” may reflect the appearance of the term in “clinical significance” is not advisable unless operationally
FDA regulations concerning clinical research activities. defined.

Clinical Investigator: A medical researcher in charge of Clinical study (trial) report: A written description of a
carrying out a clinical trial’s protocol. study of any therapeutic, prophylactic, or diagnostic agent
conducted in human subjects, in which the clinical and
Clinical pharmacology: Science that deals with the statistical description, presentations, and analysis are fully
characteristics, effects, properties, reactions, and uses integrated into a single report.
of drugs, particularly their therapeutic value in humans,

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