NOTE: Assessments are usually measured at a certain time, and usually are not compounded significantly by combining several simultaneous measurements to form a derived assessment (e.g., BMI) or a result of statistical analysis. A quality by which records and data can be traced back to the subject to whom they pertain, as well as to those persons who have acted on the records. In data modeling, refers to specific items of data that can be collected for a class. 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 (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a pharmaceutical company). A written evaluation by the auditor of the results of the audit. A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record.
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NOTE: There are a number of potential analysis sets, including, for example, the set based upon the intent-to-treat principle. Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. Designation for a planned activity, often marking the transition between epochs or elements of a clinical study plan (e.g., "FPFV—first patient first visit"). Personal data which have been processed to make it impossible to know the person with whom the data are associated.
Applicable particularly for secondary use of health data. Computer application: software designed to fill specific needs of a user; for example, software for navigation, project management, or process control. Regulatory application: application made to a health authority to investigate, market, or license a new product or indication. An official communication from FDA to an NDA/BLA sponsor that lists issues to be resolved before an approval can be issued.
NOTE: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality.
[WHO Technical Report 498(1972); ICH E2A] adverse event (AE).
In multi-user computer systems, a system administrator defines for the system which users are allowed access to the system and what privileges of use are permitted. Used to ensure that consent forms, surveys, and other clinical trial documents will be clear and accurate in the translated form. Information pertinent to the understanding of a protocol.
NOTE: Examples include investigator brochure, literature review, history, rationale, or other documentation that places a study in context or presents critical features. Trial in which a particular type of subject is equally represented in each study group. An indicator of the throughput (speed) of data flow on a transmission path; the width of the range of frequencies on which a transmission medium carries electronic signals.[Modified from 21 CFR 314.3; Guidance to Industry and FDA Staff (10/08/2003)] arm.A planned sequence of elements, typically equivalent to a treatment group. A measurement, evaluation, or judgment for a study variable pertaining to the status of a subject.Another example is that the pharmacy system may transmit an alert to the prescribing physician that a potentially dangerous drug-drug interaction may occur based on the current list of medications. A written description of a change(s) to, or formal clarification of, a protocol. Founded in 1918, ANSI itself does not develop standards.Another example is that the system may notify a patient's physician that laboratory results (that are not within normal limits) are available. 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 a calculated result or decision. The likelihood that a relationship observed between two variables is due to chance. ANSI's roles include serving as the coordinator for US voluntary standards efforts, acting as the approval body to recognize documents developed by other national organizations as American National Standards, acting as the US representative in international and regional standards efforts, and serving as a clearinghouse for national and international standards development information. An organized collection of data or information with a common theme arranged in rows and columns and represented as a single file; comparable to a database table.[Modified from 21 CFR 314.3; Guidance to Industry and FDA Staff (10/08/2003)] approval (in relation to institutional review boards).