SOCRA Certification Exam 2022/2023 with Complete Solution

Biometrics - ANSWER A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - ANSWER An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - ANSWER An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. (21 CFR, Sec. 11.3) Electronic Record - ANSWER Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. (21 CFR, Sec. 11.3) Electronic Signature - ANSWER A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the handwritten signature. (21 CFR, Sec. 11.3) Open system - ANSWER An environment in which system access is not controlled by persons who are responsible for the content of the electronic records that are on the system. (21 CFR, Sec. 11.3) Clinical Investigation - ANSWER - Any experiment that involves a test article and one or more human subjects - Subject to requirements for prior submission or is not subject to requirements for prior submission to the FDA under the Act - Results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. (21 CFR, sec. 50.3) Investigator - ANSWER An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (21 CFR, sec. 50.3) Sponsor - ANSWER A person who initiates a clinical investigation but who does not actually conduct the investigation i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than the individual (e.g., corporation or agency) that uses one or more of its