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[Show more]Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER-Determining that the study has a maximization of benefits and a minimization of risks. 
 
Which of the following are the three principles discussed in the Belmont Rep...
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Add to cartWhich of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER-Determining that the study has a maximization of benefits and a minimization of risks. 
 
Which of the following are the three principles discussed in the Belmont Rep...
Declaration of Helsinki (1964, 1975) - ANSWER -Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) 
 
Good Clinical Practice (GCP) - ANSWER -ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of...
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Add to cartDeclaration of Helsinki (1964, 1975) - ANSWER -Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) 
 
Good Clinical Practice (GCP) - ANSWER -ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of...
Nuremburg Code elements - ANSWER -1. Voluntary informed consent 
2. research benefits society 
3. should be based on prior animal work 
4. avoid suffering and injury 
5. research where death and disabling injury is expected shouldn't be conducted 
6. risks should be justified 
7. proper preparation...
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Add to cartNuremburg Code elements - ANSWER -1. Voluntary informed consent 
2. research benefits society 
3. should be based on prior animal work 
4. avoid suffering and injury 
5. research where death and disabling injury is expected shouldn't be conducted 
6. risks should be justified 
7. proper preparation...
Closed System - ANSWER -An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) 
 
Digital Signature - ANSWER -An electronic signature based upon cryptographic methods of originator authentic...
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Add to cartClosed System - ANSWER -An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) 
 
Digital Signature - ANSWER -An electronic signature based upon cryptographic methods of originator authentic...
Quality - ANSWER -ICH Q 
 
Efficacy - ANSWER -ICH E 
 
Safety - ANSWER -ICH S 
 
Multidisciplinary - ANSWER -ICH M 
 
guidance for industry, consolidated guideance - ANSWER -ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - ANSWER -ICH E2A 
 
Safety pharmacology studies for huma...
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Add to cartQuality - ANSWER -ICH Q 
 
Efficacy - ANSWER -ICH E 
 
Safety - ANSWER -ICH S 
 
Multidisciplinary - ANSWER -ICH M 
 
guidance for industry, consolidated guideance - ANSWER -ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - ANSWER -ICH E2A 
 
Safety pharmacology studies for huma...
When a short form is used for informed consent the witness must sign the short form or the summary? - ANSWER- False-they must sign both 
 
What is FDA form 3454 - ANSWER- Certification Financial Interests and Arrangements of Clinical Investigators 
 
What are the three main basic ethical principles ...
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Add to cartWhen a short form is used for informed consent the witness must sign the short form or the summary? - ANSWER- False-they must sign both 
 
What is FDA form 3454 - ANSWER- Certification Financial Interests and Arrangements of Clinical Investigators 
 
What are the three main basic ethical principles ...
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