2024 CITI Training Questions With 100% Correct Answers!!

research - a systematic investigation designed to develop or contribute to generalizable knowledge systematic - scientific methods; use of data analyses; methodical process designed - a detailed plan with a purpose generalizable - the intent to contribute to the knowledge base of your profession/discipline by drawing conclusions or making claims based on systematic methods quality improvement projects - designed with the goal of measuring or improving the institution's clinical practices or administrative processes single case report - not systematic investigation; no statistical or data analysis; no outcome measures quality improvement and single case - activities usually not defined as research 3 - number of cases to be considered research obtaining data by interacting or intervening with living individuals; accessing identifiable private information about individuals - requirements for research clinical investigation - any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission t of the FDA or is not subject to requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for research or marketing permithuman subject - an individual who is or becomes a participant in research, either as a recipient of the test article or as a control test article - any drug, including a biological product or medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act FDA Human Subjects Research - any research that involves an experiment that includes a test article and human subject; subject to FDA submission or inspection category 4 - most common category of exemption established or commonly accepted educational settings on normal educational practices, educational tests, surveys, interviews, observation of public behavior, tests, surveys interviews with public officials, study of existing data, records, or specimens if recorded in way subjects cannot be identified, research approved/conducted by Federal Agencies on public benefit programs, evaluation of taste or food quality - research that is eligible for exemption may not record identifying info; may not receive specimens with codes or identifiers that allow access to PHI, may not combine follow-up phone calls or surveys and qualify for exempt status - key issues that contribute to category 4 determinations minimal risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests waivers or alterations of consent, expedited or non-committee review, waiver of documentation of consent - procedural options that hinge on determination of minimal risk expedited - means the research does not have to go to the full board for review category 1 - expedited review category where clinical studies of drugs and medical devices only when condition a or b is met: a=research on drugs for which an investigational new drug application is not required/b=research on medical devices for which an investigational device exemption application isnot required or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling category 2 - expedited review category: collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: a=from healthy non pregnant adults who weigh at least 110 pounds (may not exceed 550 ml in an 8 week period, collection at most 2x per week)/b=from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected