SoCRA Certification Exam with complete solution

SoCRA Certification Exam with complete solution Biometrics -Correct 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 -Correct 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 -Correct 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 -Correct 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 -Correct 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 -Correct 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 -Correct Answer-Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. (21 CFR, sec. 50.3) Investigator -Correct 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)