CCRP Bundled Exams with complete solution Everything you need is here

When isn't an IND application needed? - IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) - FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's br...

What influences a persons metabolic rate? - Exercise, gender, genetics, age Which is the macronutrient that provides more than twice as many calories as the other two - Fat Foods that raise insulin levels have... - added sugar When feeling stressed, you may feel relief after eating a piece of cho...

21 CFR 50 - Protection of Human Subjects Sponsor - a person who initiates a clinical investigation, but who does not actually conduct the investigation Sponsor-investigator - an individual who both initiates and actually conducts (alone or with others) a clinical investigation Human subject - a...

How are lipids carried - on lipoproteins in the blood because they are insoluble in water Proteins found on lipoproteins - apolipoproteins Density of lipoprotein with less lipid and greater protein - more dense Density of lipoprotein with more lipids and less protein - less dense Major bloodstre...

Biometrics - 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 - An environment in which system ...

Assessment - an objective evaluation or appraisal of an individual's health status, including acute and chronic conditions How does an assessment gather information? - through collection of data, observation, and physical examination What type of assessment? •Gather information about the pa...

Monitoring - The purpose of trial monitoring are to verify that: 1) The rights and well being of human subjects are protected 2) The reported trial data are accurate, complete, and verifiable from source documents. 3) The conduct of the trial is in compliance with the currently approved protocol/...