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| A constant in a model, or a constant that wholly or partially characterizes a function of probability distribution. |
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| person under a physician's care for a particular disease or condition |
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| contains demographic, medical and treatment information about a patient or subject. It may be paper based or a mixture of computer and paper records |
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| a deisgnated period during the course of a clinical trial in which subjects are observed and no treatment is administered. |
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| The branch of pharmacology that studies reactions between drugs and living structures including the processes of bodily responses to pharmacolgical, biological, physiological and therapeutic efforts |
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| Branch of economics that applies cost-benefit, cost-utility, cost minimization and cost-effectiveness analyses to compare the economics of different pharmaceutical products or to compare drug therapy to other treatments. Sometimes referred to as outcomes research. |
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| The study of the way drugs interact with genetic makeup or the genetic response to a drug |
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| The study of the porcesses of bodily absorption, distribution, metabolism and excretion of compounds and medicines |
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| The science that deals with the characteristics, effects and uses of drugs and their interactions with living organisms. |
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| Term used for adverse event monitoring and reporting in some countries |
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| Facility designed specifically for conducting studies involving normal healthy volunteers. It may be operated by a sponsor company, a CRO or a special unit of a hospital |
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| A pharmaceutical preparation that contains no active agent. In blinded studies it is generally made to look just like the active product |
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| postmarketing surveillance |
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| Ongoing safety monitoring of marketed drugs |
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| A clinical study desigend to examine the benefits of a product under real-world conditions |
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| invesitgation in whic a group of subjects is recruited and monitored in accordance with criteria described in the protocol |
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| A document that describes the design, methodology, statistical considerations and organization of a trial |
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| A written description of a change to or formal clarification of a protocol |
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| one that cannot be measured numerically (ie. race, sex) |
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| All those planned and sytematic actions that are established to ensure that the trial is performed and the data are generated, documented and reported in accordance with GCPs and applicable regulatory requirements |
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| The operational activities and techniques undertaken within the quality assurance system to verify that the requirements for quality of trial-related activities are fulfilled |
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| one that can be measured numerically |
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| one that can be measured numerically |
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| assignment of subjects to treatment or control groups in an unpredictable way. Assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience |
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| Table of numbers with no apparent pattern used in the selection of random samples for clinical trials |
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| Memebers of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection |
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| The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias |
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| Records of original observations, measurements, and acitivities without conclusions or interpretations |
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| process used by sponsors to select investigators and subjects for a clinical study |
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| Time period during which investigators must complete enrollment of their quota of subjects for a trial |
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| The number of subjects that must be enrolled in a study to meet the requirements of the study protocol |
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| Bodies having the power to regulate - sometime referred to as Competent Authorities |
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| the conclusion a study sets out to support or disprove |
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| the probability of harm or discomfort for subjects |
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| relative freedom from harm - lack of harmful side effects |
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| a program or series of instructions that are carried out by another program |
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| Any untoward medical occurence that results in: death, is life threatening, requires inpatient hospitalization, or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
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| serious adverse experience |
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Definition
| Any experience that suggests a significant hazard, contraindication, side effect or precaution. (Nordic GCTP) |
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| All information in original records and certified copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial |
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| Original documents, data, and records |
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| an individual, company, institution, or organization whic takes responsibility for the initiation, management, and/or financing of a clinical trial |
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| An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the invesitgational product is administered to, dispensed to, or used by a subject |
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| indicator of the relative variability of a variable around its mean |
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| standard operating procedure |
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Definition
| Detailed, written instructions to achieve uniformity of the performance of a specific function |
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| State that applies when a hypothesis is rejected. Whether or not a given result is significant depends on the significance level adopted |
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| involving a random variable, chance or probability |
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| same as clinical research coordinator |
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| Any individual member of the clinical trial team designated and supervised by the investigator at the trial site to perform critical trial-related procedures or to make important trial related decisions. |
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