Ich e 6 Study guides, Class notes & Summaries
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RAC Exam practice (Quizzes With Correct Ans) Already Passed!!
- Exam (elaborations) • 17 pages • 2024
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Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) 
Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable 
poisonous substances(1:1) - Answer-A: Proof of efficacy 
Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey 
Amendments b) Hatch-Waxman Act c) Controlled Substances Act d) Kefauver-Harris Amendments (1:2) - 
Answer-D: Kefauver-Harris Amendments 
The ...
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SOCRA CCRP Sponsor, Investigational Drug and Device Exam Review Questions and Answers 2023/2024
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SOCRA CCRP Sponsor, Investigational Drug and Device Exam Review Questions and Answers 2023/2024 
April 30 1996 - correct answer ICH GCP Development Date 
 
Quality - correct answer ICH Q 
 
Efficacy - correct answer ICH E 
 
Safety - correct answer ICH S 
 
Multidisciplinary - correct answer ICH M 
 
guidance for industry, consolidated guideance - correct answer ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A 
 
Safety pharmacology studies for human ...
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AQA AS GERMAN 7661/1 Paper 1 Listening, Reading and Writing Version: 1.0 Final *jun237661101* IB/G/Jun23/E6 7661/1QUESTION PAPER & MARKING SCHEME/ [MERGED] Marl( scheme June 2023
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AQA 
AS 
GERMAN 
7661/1 
Paper 1 Listening, Reading and Writing 
Version: 1.0 Final 
*jun* 
IB/G/Jun23/E6 7661/1 
For Examiner’s Use 
Question Mark 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
TOTAL 
Tuesday 16 May 2023 Morning Time allowed: 1 hour 45 minutes 
Materials 
For this paper you must have: 
• listening material. 
Instructions 
• Use black ink or black ball-point pen. 
• Fill in the boxes at the top of this page. • Answer all questions in Section A and all questions in Section B. 
• Yo...
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CITI Training Exam Questions With Complete Solutions Latest Update 2023-2024 (Score A+)
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CITI Training Exam Questions With Complete Solutions Latest Update (Score A+). What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, 
Clinical Development (Phase I-III), NDA submission, 
Marketing (Phase IV) 
When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases 
(human trials). *30 day process. 
What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV 
marketing phase. 
How long does the NDA su...
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SOCRA CCRP Exam With 100% Correct Answers 2023
- Exam (elaborations) • 17 pages • 2023
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April 30 1996 - Correct Answer-ICH GCP Development Date 
Quality - Correct Answer-ICH Q 
Efficacy - Correct Answer-ICH E 
Safety - Correct Answer-ICH S 
Multidisciplinary - Correct Answer-ICH M 
guidance for industry, consolidated guideance - Correct Answer-ICH E 6 
Clinical Safety Data Management Definitions and Standards - Correct Answer-ICH E2A 
Safety pharmacology studies for human pharmaceuticals - Correct Answer-ICH S7A 
Electronic records, electronic signatures - Correct Answer-21 CFR Par...
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CCRP SOCRA Exam - Practice Exam 1
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CCRP SOCRA Exam - Practice Exam 1 
 
The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? 
 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 
B) 5 
A significant risk device is defined as an investigational device that is: 
 
A) Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject 
 
B) P...
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Test Bank for Human Biology 12th Edition By Mader | VERIFIED 2023/2024
- Exam (elaborations) • 248 pages • 2023
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The smallest unit of an element that still retains the chemical and physical properties of that element 
is called 
A. an 
isotope. 
B. a 
nucleus. 
C. an 
atom. 
D. a molecular 
bond. 
E. a 
neutrino. 
2. In an atom, the number of protons always equals the number 
A. of 
electrons. 
B. of 
neutrons. 
C. of neutron and 
protons. 
D. of 
quarks. 
E. of 
neutrinos. 
3. Examine the section of the periodic table in Figure 2.1. Which element will behave similarly to C? 
A. C 
a 
B. S 
C. A 
r 
D. S 
...
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SOCRA CCRP Exam|2023 LATEST UPDATE|GUARANTEED SUCCESS
- Exam (elaborations) • 20 pages • 2023
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April 30 1996 
ICH GCP Development Date 
 
 
 
Quality 
ICH Q 
 
 
 
Efficacy 
ICH E 
 
 
 
Safety 
ICH S 
 
 
 
Multidisciplinary 
ICH M 
 
 
 
guidance for industry, consolidated guideance 
ICH E 6 
 
 
 
Clinical Safety Data Management Definitions and Standards 
ICH E2A 
 
 
 
Safety pharmacology studies for human pharmaceuticals 
ICH S7A 
 
 
 
Electronic records, electronic signatures 
21 CFR Part 11 
 
 
 
Informed Consent 
21 CFR Part 50 
 
 
 
Financial Disclosures 
21 CFR Part 54 
 
 
 ...
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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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SOCRA CCRP Exam 2023 with 100% correct answers
- Exam (elaborations) • 23 pages • 2023
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SOCRA CCRP Exam questions & answers 2023 
 
 
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 
 
In...
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