Ich gcp guidelines Guides d'étude, Notes de cours & Résumés
Vous recherchez les meilleurs guides d'étude, notes d'étude et résumés sur Ich gcp guidelines ? Sur cette page, vous trouverez 283 documents pour vous aider à réviser pour Ich gcp guidelines.
All 283 résultats
Trier par
-
Good Clinical Practice - ICH GCP Guidelines - Monitor's Responsibilities 2023/2024
- Examen • 1 pages • 2024
-
Disponible en pack
-
- €9,21
- + en savoir plus
Good Clinical Practice - ICH GCP Guidelines - Monitor's ResponsibilitiesWhat is the overall purpose of monitoring? - correct answer To verify 
- the rights and well-being of human subjects are protected 
- reported trial data are accurate, complete and verifiable from source documents 
- the study is conducted in compliance with the study protocol, the GCP guidelines and applicable regulations 
 
Who appoints the monitor? - correct answer The Sponsor 
 
What does the monitor verify in regards...
-
SOCRA- 2022 QUESTIONS AND ANSWERS ALL CORRECT
- Examen • 25 pages • 2022
-
Disponible en pack
-
- €7,83
- 2x vendu
- + en savoir plus
Belmont Report was created as part of? Correct Answer: The national Research Act of 1974. 
 
Who was the Belmont Report formulated by? Correct Answer: The National Commission for the protection of human subjects in biomedical and behavioral research. 
 
What year was the publication of the FDA regulations made? Correct Answer: 1980 *1981 for the HHS and revised FDA Regulations. 
 
What year was GCP and HIPAA created? Correct Answer: 1996 
 
What is the National Research Act? Correct Answer: ...
-
Good Clinical Practice - ICH GCP Guidelines - Monitor's Responsibilities 2023/2024
- Examen • 1 pages • 2023
-
Disponible en pack
-
- €9,21
- + en savoir plus
Good Clinical Practice - ICH GCP Guidelines - Monitor's Responsibilities 
What is the overall purpose of monitoring? - correct answer To verify 
- the rights and well-being of human subjects are protected 
- reported trial data are accurate, complete and verifiable from source documents 
- the study is conducted in compliance with the study protocol, the GCP guidelines and applicable regulations 
 
Who appoints the monitor? - correct answer The Sponsor 
 
What does the monitor verify in reg...
-
SoCRA Certification Exam 2023 with complete answers
- Examen • 12 pages • 2023
-
Disponible en pack
-
- €16,58
- 1x vendu
- + en savoir plus
SoCRA Certification Exam 2023 with complete answers 
Biometrics 
A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) 
 
 
 
Closed System 
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) 
 
 
 
Digi...
-
ACRP CCRC Exam Prep Questions and answers 100% correct
- Examen • 26 pages • 2023
-
Disponible en pack
-
- €32,25
- 6x vendu
- + en savoir plus
ACRP CCRC Exam Prep Questions and answers 100% correctWhat are expected or possible consequences of over-estimation of recruitment potential? 
- The trial will overrun its projected timeline 
- The recruitment period will be prolonged and more sites may be needed 
- The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget 
 
 
 
What should be the first consideration when conducting a clinical trial? 
Subject welfare 
 
 
 
When is the i...
Peur de manquer quelque chose ? Alors non !
-
Good Clinical Practice - ICH GCP Guidelines - Monitor's Responsibilities Question and answers 2023/2024 verified to pass
- Examen • 1 pages • 2023
-
Disponible en pack
-
- €12,43
- + en savoir plus
Good Clinical Practice - ICH GCP Guidelines - Monitor's Responsibilities Question and answers 2023/2024 verified to pass 
What is the overall purpose of monitoring? - correct answer To verify 
- the rights and well-being of human subjects are protected 
- reported trial data are accurate, complete and verifiable from source documents 
- the study is conducted in compliance with the study protocol, the GCP guidelines and applicable regulations 
 
Who appoints the monitor? - correct answer Th...
-
CR014 exam 2024 with 100% correct answers
- Examen • 34 pages • 2024
-
Disponible en pack
-
- €16,12
- + en savoir plus
declaration of helsinki (1964) correct answers-ethical principles (31) for research with human subjects 
-international standard 
-subjects take precedence 
-combing research and clinical care 
-adapted from Nuremberg Code by the World Medical Association 
 
ICH - international conference on harmonisation correct answersinternational authority on clinical research theory and principles 
 
ICH guidelines correct answers4 major categories 
 
QUALITY - chemical/pharm. Assurance (stability testin...
-
CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023
- Examen • 11 pages • 2023
-
Disponible en pack
-
- €16,58
- 1x vendu
- + en savoir plus
CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 
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, s...
-
CCRC Module 3: GCP for the Experienced Clinical Research Professional exam with 100% complete answers
- Examen • 25 pages • 2024
-
Disponible en pack
-
- €15,66
- + en savoir plus
The ICH for GCP describes the responsibilities of these 4 groups: 
Sponsors 
Investigators 
Institutional Review Boards 
Independent Ethics Committees 
 
 
 
The International Council on Harmonisation Guidelines for Good Clinical Practice describes the responsibilities of sponsors, investigators, and institutional review boards, as well as independent ethics committees in order to: [2 Reasons] 
1. Safeguard the safery and well-being of trial subjects. 
2. Ensure the scientific integrity of the s...
-
International Council for Harmonisation ICH E6 exam 2024 with 100% correct answers
- Examen • 15 pages • 2024
-
Disponible en pack
-
- €14,74
- + en savoir plus
Goals of ICH correct answersTo standardize technical guidelines and requirements for drug marketing registrations, so that applications for marketing to various regulatory agencies around the world can occur without redundant testing 
 
ICH E6 has become correct answersThe international standard for the design, conduct, monitoring, and reporting of clinical research of investigational drugs 
 
Good Clinical Practice (GCP) correct answersenhances protection of study subjects and the integrity of ...
Vous demandez-vous pourquoi tant d'étudiants portent de beaux vêtements, ont de l'argent à dépenser et profitent de beaucoup de temps libre ? Eh bien, ils vendent sur Stuvia ! Imaginez que vos notes d'étude soient téléchargées une dizaine de fois pour 15 € pièce. Chaque. Jour. Découvrez tout sur gagner de l'argent sur Stuvia