Kaplan University

What influences a persons metabolic rate? Correct Answer: Exercise, gender, genetics, age Which is the macronutrient that provides more than twice as many calories as the other two Correct Answer: Fat Foods that raise insulin levels have... Correct Answer: added sugar When feeling stressed, you may feel relief after eating a piece of chocolate because... Correct Answer: it will raise dopamine levels What reduces the number of receptors for dopamine Correct Answer: insulin Wha...

What are expected or possible consequences of over-estimation of recruitment potential? Correct Answer: - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? Correct Answer: Subject welfare When is the investigator allowed to deviate...

5 Correct Answer: The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor Correct Answer: The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. T...

Nuremberg Code (1947) Correct Answer: A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points Correct Answer: 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. r...

Who was tried in the Nuremburg Military Tribunals and why? Correct Answer: Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? Correct Answer: After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1...

Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: Correct Answer: PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? Correct Answer: The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? Correct Answer: The subject inclusion and exclusion criteria During a multi-site clinical ...

When isn't an IND application needed? Correct Answer: 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) Correct Answer: FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional information (drug depende...

Timeline of Historical Events Correct Answer: Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report Correct Answer: respect for persons, beneficence, justice Application of Respect for Persons Correct Answer: informed consent (autonomy, choose for themselves) Application of Beneficence Correct Answer: risk/benefit analysis Application of Justice Correct Answer: appropriate selection of patients (equality) Language Le...

Non thermal effects of 20% pulsed ultrasound include what? Correct Answer: a. Facilitation of the inflammatory process (release of histamine) b. Increase in cell diffusion and membrane permeability c. Help to synthesize the extra-cellular matrix and collagen Which muscle originates on the scapula and inserts on the radius? Correct Answer: The biceps brachii muscle Spinal cord deficits appear in the following order: Correct Answer: Loss of proprioception, loss of motor function, loss o...

How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CF R 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed consent w...

Chapter 8 Federal Sentencing Guidelines (FSG) Correct Answer: Guidelines and policy in this section apply to sentencing in federal criminal prosecution when the convicted defendant is an organization FSG- 4 factors that increase ultimate punishment of an organization Correct Answer: 1.Involvement in or tolerance of criminal activity 2.Prior history of the organization 3.The violation of an order 4.The obstruction of justice FSG- The two factors that mitigate the ultimate punishment ...

Federal Sentencing Guidelines - Culpability Score Aggravating Factors Correct Answer: 1. upper-level employee participates, condones, or ignores offense 2. repeat offense 3. hinder investigation 4. awareness and tolerance of violation is pervasive Federal Sentencing Guidelines - Culpability Score Mitigating Factors Correct Answer: 1. effective compliance program 2. reported promptly 3. cooperation with investigation 4. accept responsibility Federal Sentencing Guidelines - Seven Ele...

Compliance means (Compliance Program) Correct Answer: Adherence to laws and regulations, as well as principles of ethical conduct OIG urges the ____________ to assist in the implementation of the compliance program and serves as advisors. A. Board B. CEO C. Compliance Committee D. Quality Committee Correct Answer: C. Compliance Committee A compliance professional is reviewing the policies and procedures for exclusion verifications. The policy does not state frequency of exclusion ver...

What does CHC stand for? Correct Answer: Certified Health Care Constructor What are the 4 types of Exam Questions? Correct Answer: Health Care Industry Fundamentals, PDC Process, Health Care Facility Safety, Financial Stewardship Name 5 Trends in Health Care Correct Answer: Changing Regulations; Services offered; Construction; Length of stay; Finance; Patient flow and efficiency; Name the 5 types of Health Care Facilities Correct Answer: Hospital; Outpatient facilities; ...

Affordable Care Act Correct Answer: Allowed more hospital construction bc it allowed hospitals to more confidently predict their finances. More infrastructure, tech and finance influence construction also. FGI: Guidelines (2014 Edition 2) Correct Answer: FACILITY GUIDELINES INSTITUTE: Guidelines for the design and construction of hospitals and outpatient care facilities. >Used to be published by the Federal Government >Was required to be followed to get a grant under the Hill-Burton...

Certified Healthcare Constructor (CHC) | 99 Questions with 100% Correct Answers

Concept: Inflammation Describe acute inflammatory processes •Immediate response to injury or infection •Redness, warmth, edema, pain •migration of leukocytes from blood to tissues (source) •Usually follows infection but not always Concept: Inflammation Describe the chronic inflammatory processes •Continues weeks to years after injury •Tissue repeatedly destroyed and repaired Concept: Inflammation Describe auto-immune inflammatory processes Disease occurs...

ATI-RN Assessment Level 1: Practice A and B (100 Questions Each Word by Word) with 100% Correct Answers UPDATED 2022 A nurse is assessing a preschooler who has a UTI. Which of the following should the nurse inspect? A. Diarrhea B. Abdominal Pain C. Increased Thirst D. Skin Rash - B. Abdominal Pain Other manifestations include constipation, dysuria, foul-smelling urine, fever A nurse is counseling a client who has a family history of colorectal cancer about management of nutrition to help preven...

AD Correct Answer: right ear (auris dextra) AS Correct Answer: left ear (auris sinistra) AU Correct Answer: both ears (auris uterque) ac Correct Answer: before meals ad lib Correct Answer: as desired ASAP Correct Answer: as soon as possible bid Correct Answer: twice a day c Correct Answer: with cc Correct Answer: cubic centimeter cap Correct Answer: capsule d/c Correct Answer: discontinue dil Correct Answer: dilute or dissolve elix Correct Answer: ...

Which does for is not a liquid? a. emulsions b. elixirs c. troches d. syrups Correct Answer: Troches To apply ear drops to a person 3 years of age or older, you: a. instill the drops without pulling the ear b. pull the ear down and back c. pull the ear upward and back d. pull the ear down and foward Correct Answer: pull the ear upward and back A watery preparation containing suspended particles is: a. lotion b. cream c. ointment d. powder Correct Answer: lotion A drug int...