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PHMD 5250 Exam 2 Questions and Answers 100% Solved

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PHMD 5250 Exam 2 Questions and Answers 100% Solved what event in history led to the modern era of human subject protection? - Nuremberg Trial what event in history led to the requirement of informed consent? - thalidomide tragedy what event in history led to the creation of the National Commi...

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  • November 1, 2024
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PHMD 5250 Exam 2 Questions and

Answers 100% Solved


what event in history led to the modern era of human subject protection? -

✔✔Nuremberg Trial

what event in history led to the requirement of informed consent? -

✔✔thalidomide tragedy

what event in history led to the creation of the National Commission for the

protection of human subjects of research and the belmont report? -

✔✔tuskegee study

what are the 3 basic principles of the belmont report? explain each - ✔✔1)

respect for persons: individuals should be treated at autonomous agents,

individuals with diminished autonomy are entitled to increased protection,

informed consent

2) beneficence: first, do no harm, second, maximize possible benefits and

minimize risk, study designed properly

3) justice: fairness in distribution, risks and benefits must be spread equally

across population, selection of research subjects

,©NINJANERD 2024/2025. YEAR PUBLISHED 2024.
what are the 3 steps of the informed consent process? - ✔✔1) information

2) comprehension

3) voluntary

human subject protection regulations are based on the ethical principles of

__________ - ✔✔the belmont report

what are the 3 principles of the Common Rule? - ✔✔1) review of research

by IRB

2) informed consent

3) institutional assurances of compliance

what are the 4 main tasks of an IRB? - ✔✔1) approve, disapprove or

modify research

2) conduct continuing review

3) observe and verify changes

4) suspend or terminate approval

IRB membership requirements - ✔✔- at least 5 members

- various backgrounds

- one not a scientist

- one not affiliated with institution

- can review specific types of research it oversees

,©NINJANERD 2024/2025. YEAR PUBLISHED 2024.
- know community where it takes place

- researchers may not review their own research

what is the drug approval process? - ✔✔- pre clinical studies

- IND

- application

what are the 4 phases of clinical research - ✔✔1) phase I: determine dose

range, healthy volunteer, safety and toxicity

2) phase II: patients have disease or condition, evaluates safety and

efficacy

3) phase III: larger groups, treatment vs. placebo

4) phase IV: post marketing surveillance



NDA submitted after phase III

what are the 2 areas for finances for research? - ✔✔1) funding at the

institution

2) insurance/participant responsibilities

who oversees proper receipt, handling, storage, blinding and accountability

of investigational drugs? - ✔✔investigational drug service

, ©NINJANERD 2024/2025. YEAR PUBLISHED 2024.
what are the 3 main FDA requirements for investigational drug storage? -

✔✔1) secure location, limited access

2) comply with study protocol or instructions on drug label

3) administer drug only to subjects under personal supervision

what allows pharmacists to sit for board certification and allows PGY1

residents to apply to PGY2 residencies? - ✔✔ASHP accreditation

what type of pharmacist performs these tasks: inpatient or outpatient, work

with nurses and providers, review labs, verify orders, etc. - ✔✔clinical

pharmacist

what type of pharmacist performs these tasks: work with providers in the

workroom assisting with dosing, answering drug questions, orders,

independent and joint visits, order and titrate meds, review labs -

✔✔clinical pharmacy specialists

- learned skill

- adapting principles to circumstances

- process that focuses on making organizational changes

- art of mobilizing others to want to struggle for shared aspirations -

✔✔leadership

what are the 6 skills that leaders share? - ✔✔1) clear, guiding vision

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