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CLNR 515 Terms - Week 1
CLNR 515 Terms - Week 1
73
Science
Graduate
08/25/2008

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Term
absorption
Definition
The process by which medications reach the blood stream when administered other than intravenously, for example, through nasal membranes.
Term
action letter
Definition
An official communication from the FDA to an NDA sponsor announcing an agency decision.
Term
admission criteria
Definition
Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of inclusion criteria and that none of their none of their characteristics match any one of the exclusion criteria.
Term
adverse drug reaction (ADR)
Definition
In the pre-apporval clinical experieince with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended "responses to a medicinal product" means that a causal relationship betwen a medicinal product and an adverse event is at least a reasonable possiblity.
Term
Adverse Event (AE)
Definition
Any outward medical occurence in a patient or clincial investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Term
algorithm
Definition
Step-by-step procedure for solving a mathematical problem; also used to describe step-by-step procedures for making a series of choices among alternative decisions to reach an outcome.
Term
aliquot
Definition
A part that is a definite fraction of a whole.
Term
alpha error
Definition
False positive; syn. Type I error
Term
analyte
Definition
A substance being analyzed; in chromatography, a single component of a mixture.
Term
applet
Definition
A small application, typically downloaded from a server
Term
approvable letter
Definition
An official communication from the FDA to an NDA sponsor that lists minor issues to be resolved before an approval can be issued
Term
approval (in relation to institutional review boards)
Definition
The affirmation decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice, and the applicable regulatory requirements.
Term
approval letter
Definition
An official communication from the FDA to inform an NDA sponsor of an agency decision that allows commercial marketing of the product
Term
audit
Definition
A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures, good clincial practices, and the applicable regulatory requirements.
Term
audit certificate
Definition
Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a phamraceutical company.
Term
audit report
Definition
A written evaluation by the sponsor's auditor of the results of the audit
Term
audit trail
Definition
Documentation that allows reconstruction of the course of events.
Term
balanced study
Definition
Trial in which a particular type of subject is equally represented in each study group.
Term
bandwidth
Definition
An indicator of the throughput(speed) of data flow on a transmission path; the width of the range of frequencies on which transmission medium carries electronic signals. All digital and analog signals have a bandwidth.
Term
baseline assessment
Definition
Assessment of subjects as they enter a trial and before they receive any treatment.
Term
Bayesian Statistics
Definition
Statisitcal approach named for Thomas Bayes (1701-1761) that has among its features, giving a subjective interpretation to probability, accepting the idea that that it is possible to talk about the probability of a hypotheses being true and of parameters having particular values
Term
beta error
Definition
False negative; Type II error
Term
between-subject variation
Definition
in a parallel trial design, differences between subjects are used to assess treatment differences
Term
bioanalytical assays
Definition
Methods for quantitative measurement of a drug, drug metabolites or chemicals in biological fluids.
Term
bioavailability
Definition
Rate and extent to which a drug is either absorbed or is otherwise available to the treatment site in the body.
Term
bioequivalence
Definition
Scientific basis on which generic and brand-name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given at the same dosage under similar conditions.
Term
biostatistics
Definition
Branch of statistics applied to the analysis of biological phenomenea.
Term
blind study
Definition
One in which the subject or the investigator (or both) are unaware of what trial product a subject is taking.
Term
blinded medications
Definition
Products that appear idential in size, shape, color, flavor, and other attributes to make it very difficult for subjects and investigators to determine which medication is being administered.
Term
blinding/masking
Definition
A procedure in which one or more parties to the trial are kept unaware of the treatment assignments.
Term
browser
Definition
Computer program that runs on the user's desktop and is used to navigate the world wide web.
Term
cache
Definition
Storage area on the computer's hard drive where the browser stores (for a limited time) web pages and/or graphic elements
Term
carry-over effect
Definition
Effects of treatment that persist after treatment has stopped, sometime beyond the time of a medication's known biological activity.
Term
Case Report Form (CRF)
Definition
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.
Term
categorical data
Definition
Data evaluated by sorting into various categories(for example severe, moderate, and mild categories)
Term
causality assessment
Definition
Determining whether there is a reasonable possiblity that the drug caused or contributed to an adverse event. It includes assessing temporal relationships, dechallenge/rechallenge information, association with underlying disease, and the presence (or absence) of a more likely cause.
Term
circadian rhythm
Definition
Biological timing and rhythmicity that, in human beings, is characterized by cycles of approximately 24 hours
Term
clean database
Definition
One from which errors have been eliminated and in which measurements and other values are provided in the same units
Term
client
Definition
A program that makes a service request of another (the server) that fulfills the request.
Term
clinical research associate
Definition
Person employed by a sponsor, or by a contract research organization acting on a sponsor's behalf who monitors the progress of investigator sites participating in a clinical study.
Term
clinical significance
Definition
Change in a subject's clinical condition regarded as important whether or not due to the test article. Should be stated in the protocol.
Term
clinical trial
Definition
Systematic study of a test article in one or more human subjects intended to discover or verify clinical, pharmacological and/or pharmacodynamic effects of an investigational product, and/or to study absorption, distribution, metabolism, excretion, of an investigational product, with the object of ascertaining its safety and/or efficacy.
Term
clinical trial report
Definition
A written description of a trial of any therapeutic, prophylactic, or diagnostic conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.
Term
Clinical trial exemption
Definition
A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application. Approval means that the company is exempt from the requirement to hold a clinical trial certificate.
Term
Clinical trial materials
Definition
Complete set of supplies provided to an investigator by the trial sponsor.
Term
coding
Definition
In clinical trials, the process of assigning data to categories for analysis.
Term
cohort
Definition
Group of subjects in a clinical trial followed up at regular predetermined intervals.
Term
comparative study
Definition
One in which an investigative drug is compared against another product, either active drug or placebo.
Term
comparator
Definition
An investigational or marketed product, or placebo used as reference in a clinical trial.
Term
Competent Authority (CA)
Definition
The regulatory body charged with monitoring compliance with the national statutes and regulation of European Member States.
Term
compliance
Definition
Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.
Term
confidentiality
Definition
Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.
Term
Conformity Assessment
Definition
The process by which compliance with the Essential Requirements (ER) is assessed.
Term
Consent Form (CF)
Definition
Document used during the consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved.
Term
Consumer Safety Officer
Definition
FDA official who coordinates the review process of various applications.
Term
Contract
Definition
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.
Term
1571
Definition
Form for IND application
Term
30-day hold
Definition
Time period between filing a protocol under an IND application and FDA's okay to proceed with enrollment.
Term
3500
Definition
Voluntary form used by health professionals, consumers and patients to submit reports regarding adverse events and product problems with FDA regulated products.
Term
3500A
Definition
Mandatory form used by user facilities, importers and manufacturers of FDA-regulated products to submit reports of adverse events and product problems with FDA-regulated products.
Term
356H
Definition
Form to market a new drug, biologic or antibiotic drug for human use.
Term
482
Definition
Form for notice of inspection.
Term
483
Definition
Form on Inspection Report for Inspectional Observations
Term
505(b)(2)
Definition
An NDA containing one or more investigations necessary for approval that were not conducted by applicant and for which applicant has no right or reference (previously known as a "paper" NDA).
Term
510(k)
Definition
A premarket notification submitted to FDA to demonstrate that the medical device to be marketed is as safe and effective or is substantially equivalent to a legally marketed device.
Term
Amendment
Definition
Additions or changes to an NDA, PMA, or PMA Supplement still under review. Includes Safety Updates
Term
Approved
Definition
FDA designation given to drugs, biologics and medical devices that have approved marketing applications (NDA, BLA, or PMA).
Term
Biologic
Definition
Any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of disease or injuries in man.
Term
Blue Book
Definition
Requirements of laws and regulations enforced by the FDA.
Term
Class I Device
Definition
Low-risk device requiring general controls to assure safety and effectiveness.
Term
Class II Device
Definition
Requires general and special controls to ensure safety and efficacy. Special controls may include mandatory performance standards, patient registries for implantable devices, and postmarket surveillance. Requires 501(k) unless exempted. May require clinical trials.
Term
Class III Device
Definition
Requires general controls, special controls and PMA; includes devices that are life-sustaining, life supporting or pose potential risk to patients. PMA may require clinical trials.
Term
Clearance
Definition
Devices that receive permission to market, not approval. Designation based on demonstrating substantial equivalence to a preamendment device or another device reviewed inder section 501(k) of the FD&C Act.
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