SOCRA CCRP Study guides, Class notes & Summaries
Looking for the best study guides, study notes and summaries about SOCRA CCRP? On this page you'll find 166 study documents about SOCRA CCRP.
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SOCRA - CCRP (high level) Exam Questions & Answers 100% Accurate
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Nuremberg Code (1947) - 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 - 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. right to end tria...
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SOCRA CCRP Exam Flashcards Questions With Complete Solutions
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Timeline of Historical Events - ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 
 
The Three Principles of the Belmont Report - ANSWER-respect for persons, beneficence, justice 
 
Application of Respect for Persons - ANSWER-informed consent (autonomy, choose for themselves) 
 
Application of Beneficence - ANSWER-risk/benefit analysis 
 
Application of Justice - ANSWER-appropriate selection of patients (equality) 
 
Language Level ICF - ANSWER-6th-8th grade 
 
8 basi...
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SOCRA CCRP Exam Questions Perfectly Answers
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April 30 1996 - ANSWER-ICH GCP Development Date 
 
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 human pharmaceuticals - ANSWER-ICH S7A 
 
Electronic records, electronic signatures - ANSWER-21 CFR Part 11 
 
Informed Consent - ANSWER-21 CFR Part 50 
 
Fina...
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Socra CCRP Exam Questions And Answers 100% Accurate
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Contract Research Organization - ANSWER-A person or an organization (commercial, academic, or other) contracted by the sponsor to 
perform one or more of a sponsor's trial-related duties and functions. 
 
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 princip...
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SOCRA CCRP EXAM 2024 QUESTIONS WITH COMPLETE SOLUTIONS
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A patient received an initial dose and had no initial reaction. The protocol says the patient needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - ANSWER-444mg^3/m 
 
Which countries are included in the ICH GCP? - ANSWER-European Union, Japan, United States, Canada and Switzerland 
 
What is the monitor not responsible for? 
A) Patient information 
B) Sponsor SOP 
C) Protocol/ICF 
D) Reporting to IRB - ANSWER- 
 
According to ICH E6, an inspection is define...
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SOCRA CCRP exam questions and answers already graded A+| Updated & Verified | 2024
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Timeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 
1979 
The Three Principles of the Belmont Report - respect for persons, beneficence, justice 
Application of Respect for Persons - informed consent (autonomy, choose for themselves) 
Application of Beneficence - risk/benefit analysis 
Application of Justice - appropriate selection of patients (equality) 
Language Level ICF - 6th-8th grade 
8 basic elements of ICF - 1. purpose, duration, and procedu...
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SOCRA - CCRP (high level) Exam Questions with 100% Correct Answers Bundled Package
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SOCRA - CCRP (high level) Exam Questions with 100% Correct Answers
SOCRA CCRP Reporting & Timelines Exam Questions with 100% Correct Answers
CCRP Exam Questions with 100% Correct Answers
SoCRA Certification Exam Questions with 100% Correct Answers

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SOCRA CCRP Reporting & Timelines Exam Questions with 100% Correct Answers
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A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect Correct Answer 5, 15 
 
IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation Correct Answer 3 
 
Al IRB records need to be kept for ____ years follow completion of research Correct Answer 3 
 
FDA will provide w...
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SOCRA - CCRP (high level) Exam Questions with 100% Correct Answers
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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. right...
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SOCRA CCRP ACTUAL EXAM 300 QUESTIONS AND CORRECT DETAILED ANSWERS TOP RATED VERSION FOR 2024-2025 ALREADY A GRADED WITH EXPERT FEEDBACK|BRAND NEW|REVISED
- Exam (elaborations) • 53 pages • 2024
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SOCRA CCRP ACTUAL EXAM 300 QUESTIONS 
AND CORRECT DETAILED ANSWERS TOP 
RATED VERSION FOR ALREADY A 
GRADED WITH EXPERT FEEDBACK|BRAND 
NEW|REVISED