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CRP CCRC Exam - CITI GCP Flashcards with verified solutions
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CRP CCRC Exam - CITI GCP Flashcards with verified solutions
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CRP CCRC Exam - CITI GCP FlashcardsBelmont Report (1979) - correct answer ✔✔Created to summarize basic ethical principles for research.
Pharmacodynamics (PD) - correct answer ✔✔Describes the effects of the agent on the body.
3 basic ethical principles of Belmont Report - correct answer ✔✔1. Respect for Persons
2. Beneficence
3. Justice
Respect for Persons - correct answer ✔✔Treating persons as autonomous agents and protecting those
with diminished autonomy.
Ex: Providing informed consent (accurate information about the study and its procedures), ensuring
comprehension and that patients' participation is voluntary in research.
Beneficence - correct answer ✔✔Obligation to secure persons' wellbeing, "do good", maximize possible
benefits and minimize possible harms.
Justice - correct answer ✔✔Fairness in distribution.
Distribution of benefits and burdens to each person:
1. an equal share
2. according to individual need
3. according to individual effort
4. according to societal contribution
5. according to merit
Informed Consent - correct answer ✔✔Document voluntarily signed by patient that clearly describes
purpose, methods, procedures, anticipated benefits, and risks of a diagnostic or treatment procedure.
, Incomplete Disclosure - correct answer ✔✔Withholding some information in order to conduct an
unbiased study when informing patients of some pertinent aspect(s) of the study is likely to impair the
validity of the research.
Justifications for Incomplete Disclosure - correct answer ✔✔Incomplete Disclosure is only justified when:
1. it is truly necessary to accomplish goals of the research
2. there are no undisclosed risks to subjects that are more than minimal risk
3. there is an adequate plan for debriefing subjects when appropriate and for dissemination of research
results to them
Coercion - correct answer ✔✔An overt threat or harm is intentionally presented by one person to
another to obtain compliance.
Undue Influence - correct answer ✔✔Occurs through offer of an excessive, unwarranted, inappropriate,
or improper reward in order to obtain compliance.
Risk - correct answer ✔✔Possibility that harm may occur, includes chance (probability) and severity
(magnitude) of envisioned harm.
Benefit - correct answer ✔✔Something of positive value related to health or welfare.
International Council for Harmonization (ICH) E6 Guideline - correct answer ✔✔To aid in compliance
with regulatory requirements and pertains to conducting clinical trials and biologics according to Good
Clinical Practice (GCP) standards.
-Utilized by U.S., Europe, Japan, and other countries (international)
Companies must provide evidence of _____ before marketing their product. - correct answer
✔✔Product SAFETY and EFFICACY as shown by clinical trials.
FDA approval of product or equivalent to also be obtained prior to marketing.
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