This site uses cookies. Some of these cookies are essential to the operation of the site, while others help to improve your experience by providing insights into how the site is being used. For more information, please see the ProZ.com privacy policy.
Cookie settings

Translation glossary: Clinical Trials glossary

Creator:
LingoConsult
LingoConsult
Filter
Reset
Showing entries 1-50 of 82
Next »
 
ADVERSE REACTION(Adverse Event.) An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time (See Side Effects). 
Englisch
ADVOCACY AND SUPPORT GROUPSOrganizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools 
Englisch
APPROVED DRUGSIn the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves sever 
Englisch
ARMAny of the treatment groups in a randomized trial. Most randomized trials have two \"arms,\" but some have three \"arms,\" or even more (See Randomiz 
Englisch
BASELINE1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an 
Englisch
BIASWhen a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by 
Englisch
BLINDA randomized trial is \"Blind\" if the participant is not told which arm of the trial he is on. A clinical trial is \"Blind\" if participants are una 
Englisch
CLINICALPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. 
Englisch
CLINICAL ENDPOINTSee Endpoint. 
Englisch
CLINICAL INVESTIGATORA medical researcher in charge of carrying out a clinical trial\'s protocol. 
Englisch
CLINICAL TRIALA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical tri 
Englisch
COHORTIn epidemiology, a group of individuals with some characteristics in common. 
Englisch
COMMUNITY-BASED CLINICAL TRIAL (CBCT)A clinical trial conducted primarily through primary-care physicians rather than academic research facilities. 
Englisch
COMPASSIONATE USEA method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who 
Englisch
COMPLEMENTARY AND ALTERNATIVE THERAPYBroad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or tr 
Englisch
CONFIDENTIALITY REGARDING TRIAL PARTICIPANTSRefers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial par 
Englisch
CONTRAINDICATIONA specific circumstance when the use of certain treatments could be harmful. 
Englisch
CONTROLA control is the nature of the intervention control. 
Englisch
CONTROL GROUPThe standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or t 
Englisch
CONTROLLED TRIALSControl is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimenta 
Englisch
DATA SAFETY AND MONITORING BOARD (DSMB)An independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progres 
Englisch
DIAGNOSTIC TRIALSRefers to trials that are are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usuall 
Englisch
DOSE-RANGING STUDYA clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is leas 
Englisch
DOUBLE-BLIND STUDYA clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental dr 
Englisch
DOUBLE-MASKED STUDYSee Double-Blind Study. 
Englisch
DRUG-DRUG INTERACTIONA modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either subst 
Englisch
DSMBSee Data Safety and Monitoring Board. 
Englisch
EFFICACY(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is 
Englisch
ELIGIBILITY CRITERIASummary criteria for participant selection; includes Inclusion and Exclusion criteria. (See Inclusion/Exclusion Criteria) 
Englisch
EMPIRICALBased on experimental data, not on a theory. 
Englisch
ENDPOINTOverall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. 
Englisch
EPIDEMIOLOGYThe branch of medical science that deals with the study of incidence and distribution and control of a disease in a population. 
Englisch
EXCLUSION/INCLUSION CRITERIASee Inclusion/Exclusion Criteria. 
Englisch
EXPANDED ACCESSRefers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants 
Englisch
EXPERIMENTAL DRUGA drug that is not FDA licensed for use in humans, or as a treatment for a particular condition (See Off-Label Use). 
Englisch
FDASee Food and Drug Administration. 
Englisch
FOOD AND DRUG ADMINISTRATION (FDA)The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and 
Englisch
HYPOTHESISA supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation. 
Englisch
INCLUSION/EXCLUSION CRITERIAThe medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such fa 
Englisch
INDSee Investigational New Drug. 
Englisch
INFORMED CONSENTThe process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughou 
Englisch
INFORMED CONSENT DOCUMENTA document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedu 
Englisch
INSTITUTIONAL REVIEW BOARD (IRB)1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the 
Englisch
INTENT TO TREATAnalysis of clinical trial results that includes all data from participants in the groups to which they were randomized ( See Randomization) even if 
Englisch
INTERVENTION NAMEThe generic name of the precise intervention being studied. 
Englisch
INTERVENTIONSPrimary interventions being studied 
Englisch
INVESTIGATIONAL NEW DRUGA new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for dia 
Englisch
IRBSee Institutional Review Board. 
Englisch
MASKEDThe knowledge of intervention assignment. See Blind 
Englisch
NATURAL HISTORY STUDYStudy of the natural development of something (such as an organism or a disease) over a period of time. 
Englisch
Next »

Public glossaries

My glossaries

Close search
All of ProZ.com
  • All of ProZ.com
  • Begriffsuche
  • Jobs
  • Foren
  • Multiple search