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A 510(k) device refers to a device classified under Section 510(k) of the United States Food, Drug, and Cosmetic Act (a.k.a. Premarket Notification). A device that reaches market via a 510(k) notification must be "substantially equivalent" to a predicate device on the market. A device that reaches market via the 510(k) process is not considered to be "approved" by the FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to as "cleared" or "510(k) cleared" devices.
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3.6/5
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1
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149
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An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. (Source: Drugs@FDA Glossary of Terms)
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3.6/5
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1
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152
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Association of Clinical Research Professionals (ACRP) is an organization whose purpose is to provide global leadership to promote integrity and excellence for the clinical research profession.
A
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4.6/5
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2
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146
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5
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Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (Source: FDA Regulation 21CFR210.3(7))
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2.7/5
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1
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144
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In the pre-approval clinical experience 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 related to any dose should be considered adverse drug reactions (ADR).
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2.7/5
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1
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149
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4
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An adverse event is any unfavourable and unintended sign, symptom, syndrome, or illness that appears or worsens during the period of observation in the clinical trial.
Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings are considered to be adverse events.
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0/5
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132
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See Adverse Event (AE)
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0/5
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0
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116
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See Abbreviated New Drug Application (ANDA)
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0/5
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0
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97
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In 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 several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application. (Source:
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0/5
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0
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101
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An Archive is a closed room or a separate and closed area in a room (e.g. a cabinet) in which documents, which have to be archived or materials are safely stored in an ordered fashion.
An Archive
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0/5
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110
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Person who is operationally responsible for the management of an archive and for the proper care of the material in an archive.
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0/5
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111
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Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more. (Source: www.Clinicaltrials.gov
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0/5
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98
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0/5
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114
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Status:
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A child’s affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent.
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0/5
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0
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101
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A systematic examination of trial related activities and documentation to ascertain the appropriateness of trial conduct and the validity and reliability of trial data. This examination is governed according to the trial protocol, Standard Operating Procedures (SOPs) of all parties involved, Good Clinical Practice (GCP), and all applicable regulatory and legal requirement(s).
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2.3/5
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2
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109
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0
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5
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1. 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 unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values. (Source: www.clinicaltrials.gov)
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0/5
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0
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106
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Status:
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0/5
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0
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121
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Status:
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The report created by United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979) resulting from the National Research Act (Pub. L. 93-348) sgned into U.S. law on July 12, 1974. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. The outline of the report is as follows:
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0/5
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0
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107
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One of the three ethical principles described in The Belmont Report, beneficience in the clinical research enterprise encompasses (1) do not harm and (2) maximize
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3.6/5
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1
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132
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When 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 blinding and randomization. (Source: www.clinicaltrials.gov).
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0/5
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0
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114
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Status:
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