Gcp exam - Study guides, Class notes & Summaries
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ACRP-CP Exam Review (Based on Declaration of Helsinki and ICH E2A, E6_R2, E8, E9, E11) with Complete Answers
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ACRP-CP Exam Review (Based on Declaration of Helsinki and ICH E2A, E6_R2, E8, E9, E11) with Complete Ans 
Adverse Drug Reaction (ADR) - ANSWER-All noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of phys...
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ICH GCP for CCRC Exam Prep|543 Questions and Answers 2023 Graded A+.
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ICH GCP for CCRC Exam Prep|543 Questions and Answers 2023 Graded A+. 
Adverse Drug Reaction (ADR) Correct Answer: All noxious and unintended responses to a 
medicinal product related to any dose 
E6(R1) 1 Correct Answer: Glossary of terms 
Adverse Event (AE) Correct Answer: Any untoward medical occurrence in a patient or clinical 
investigation subject administered a pharmaceutical product and which does not necessarily have 
a causal relationship with this treatment--any unfavorable and uninten...
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GCP EXAM QUESTIONS AND ANSWERS 100% CORRECT
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GCP EXAM QUESTIONS AND ANSWERS 100% CORRECT 
What words are missing from the following in ICH GCP: The Sponsor should update the XXXX as significant new information becomes available? 
investigator's brochure 
 
 
 
Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs: 
sponsor 
 
 
 
According to ICH GCP section 8, what is the purpose of IRB/IEC composition? 
A. To document that the IRB/IEC is constituted in agreement with GCP 
 
 ...
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IGCP 304 3P EXAM WITH COMPLETE SOLUTIONS
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IGCP 304 3P EXAM WITH COMPLETE SOLUTIONS 
1.	Which medication targets postprandial glucose by blocking its transport across the intestine into the bloodstream? 
Question options: 
 
 
acarbose (Precose) glipizide (Glucotrol) metformin (Glucophage) 
rosiglitazone (Avandia) 
2.	 Which type of insulin will help to reduce nocturnal hypoglycemia? 
 
Question options: 
 
NPH 
 
 
regular immediate-acting 
long-acting 
 
 
3.	What symptoms in a college student living in a dorm would be suspicious fo...
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ICH E6 - GCP EXAM WITH QUESTIONS AND ANSWERS
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ICH E6 - GCP EXAM WITH QUESTIONS AND ANSWERS ...
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ICH GCP E6 GLOSSARY EXAM LATEST UPDATE
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ICH GCP E6 GLOSSARY EXAM LATEST UPDATE...
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ACRP Boot camp Exam Questions and Answers Already Passed
- Exam (elaborations) • 21 pages • 2023
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ACRP Boot camp Exam Questions and Answers Already Passed 
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: 
a. phase 1 
b. phase 2 
c. phase 3 d. phase 4 a 
Which of the following is not a type of patient-oriented research? 
a. IND/IDE clinical trials 
b. investigator initiated trial (IIT) 
c. Post market device registries d. outcome and health services research d 
Who is ultimately responsible for all aspects of the research conducted at a site? 
...
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SOCRA EXAM PREP | 2023/ 2024 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
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SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide 
 
Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? 
 
Answer: 
1) Progress of investigations under IND 
2) Secure compliance or discontinue investigators that are not compliant and notify FDA 
3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 
4) Notify FDA, all IRBs and all investigators if drug presen...
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IGCP 304 3P EXAM WITH COMPLETE SOLUTIONS
- Exam (elaborations) • 87 pages • 2024
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IGCP 304 3P EXAM WITH COMPLETE SOLUTIONS 
1.	Which medication targets postprandial glucose by blocking its transport across the intestine into the bloodstream? 
Question options: 
 
 
acarbose (Precose) glipizide (Glucotrol) metformin (Glucophage) 
rosiglitazone (Avandia) 
2.	 Which type of insulin will help to reduce nocturnal hypoglycemia? 
 
Question options: 
 
NPH 
 
 
regular immediate-acting 
long-acting 
 
 
3.	What symptoms in a college student living in a dorm would be suspicious fo...
-
ICH GCP Exam Questions and Answers | Latest Update 2023/2024 (GRADED)
- Exam (elaborations) • 53 pages • 2023
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ICH GCP Exam Questions and Answers | Latest Update 2023/2024 (GRADED). Clinical Trial/Study Report Correct Answer: A written description of a trial/study of any 
therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical 
and statistical description, presentations, and analyses are fully integrated into a single report 
Comparator (Product) Correct Answer: An investigational or marketed product, or placebo, used 
as a reference in a clinical trial. 
Complia...
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