Gcp review practice test - Study guides, Class notes & Summaries
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SOCRA - CCRP (high level) Questions and Answers (100% Correct Solutions)
- Exam (elaborations) • 68 pages • 2023
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Nuremberg Code (1947) 
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 
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. right to end trial if needed 
 ...
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CITI GCP Training Study Guide Test.
- Exam (elaborations) • 22 pages • 2024
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CITI GCP Training Study Guide Test. 
 
 
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: 
Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. 
 
ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate that "the...
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ACRP CCRC, CCRC Study Set Already Graded A+
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ACRP CCRC, CCRC Study Set Already Graded A+ 
 
ADR 
Adverse Drug Reaction 
Audit 
Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) 
Brainpower 
Audit Certificate 
Confirmation audit took place 
Audit Report 
Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance 
Audit Trail 
Documentation of audit events 
Single Blind Study 
Subjects Unaware 
Double Blind Study ...
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 
 
Clinical Trial 
process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. 
Endpoint or Outcome 
Clinical event, measurable indicator, subject reported response 
Brainpower 
Read More 
Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of ha...
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GLP Certification Exam 2023
- Exam (elaborations) • 11 pages • 2023
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GLP Certification Exam 2023 
IND - ANS-Investigational new drug( application) 
NDA - ANS-new drug application 
Motto - ANS-if it isn't written down it never happened t 
What triggered GLP regulations - ANS-IBT 
industrial bio-test lab. 
failed audit; sponsor failure to validate data/data not critically reviewed/ non-adherence to 
protocols/inaccurate analysis/untrained personnel use 
FFDCA - ANS-federal food drug and cosmetic act 
CFR - ANS-code of federal regulation 
-anything under FDA alway...
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ICH-GCP, Exam Review Questions and answers, VERIFIED//LATEST UPDATES, 2024/25/ EXAMS PREDICTION PAPER/
- Exam (elaborations) • 2 pages • 2024
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ICH-GCP, Exam Review Questions and 
answers, VERIFIED/ 
The difference between a clinical and non-clinical study - -test subjects 
Responsible for the ongoing safety evaluation of the investigational product - -Sponsor 
TRUE/FALSE. The Guidelines for Good Clinical Practice also contains a section on the information 
requirements for non-clinical research. - -TRUE 
NOT a right of a participant in a clinical study - -full benefits after voluntary withdrawal 
The investigator and his team are res...
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CCRC Exam Verified 100% Correct!!
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CCRC Exam Verified 100% Correct!! 
 
Clinical Trial 
process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. 
Endpoint or Outcome 
Clinical event, measurable indicator, subject reported response 
Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of harm for human subjects participating in study 
Necessary controls...
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SOCRA Test practice Questions and Answers 2024
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SOCRA Test practice Questions and Answers 2024 
The Purpose of the IRB is to: -Answer-Protect the rights and welfare of human subjects 
in research 
What is the minimum number of members required by an IRB -Answer-5 
Which of the following are necessary to waive consent? 
A.Subject is unable to give consent 
B.No time or unable to contact next of kin 
C.Life-Threatening Condition 
D.No other treatment available 
E.All of the above -Answer-all of the above 
This form is used for the mandatory rep...
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set
- Exam (elaborations) • 214 pages • 2024
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 
 
Clinical Trial 
process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. 
Endpoint or Outcome 
Clinical event, measurable indicator, subject reported response 
Brainpower 
Read More 
Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of ha...
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CCRC Exam Verified 100% Correct!!
- Exam (elaborations) • 13 pages • 2024
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- $13.49
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CCRC Exam Verified 100% Correct!! 
 
Clinical Trial 
process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. 
Endpoint or Outcome 
Clinical event, measurable indicator, subject reported response 
Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of harm for human subjects participating in study 
Necessary controls...
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