Investigators brochure - Study guides, Class notes & Summaries
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ICH Guidlines with 100% correct answers
- Exam (elaborations) • 11 pages • 2024
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Adverse Event (AE) correct answersAny 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. (II.A.1) 
 
Adverse Drug Reaction (ADR) correct answersSubset of AE. Aka "side effect". All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Side effect with reasonable possibility of relatedness ...
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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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CITI GCP Training Questions and Answers Graded A+
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CITI GCP Training Questions and Answers Graded A+ 
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 ...
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CITI – GCP Exam Questions with Correct Answers
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Which of the following best describes the principle of Respect for Persons as described in the Belmont Report? Correct Answer Information, comprehension, voluntariness. 
 
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Correct Answer Determining that the study has maximized benefits and minimized risks. 
 
Development of most new drugs, from discovery to marketing approval, usually takes: Correct Answer 9 or more years...
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CCRC EXAM SOLVED 100% CORRECT!!
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CCRC EXAM SOLVED 100% CORRECT!! 
 
Protocols 
1) General Information 
2) Background info 
3) Trial objectives and purpose 
4) Trial design 
5) Selection and withdrawal of subjects 
6) Treatment of Subjects 
7) Assessment of Efficacy 
8) Assessment of Safety 
9) Statistics 
10) Source Data/Docs 
11) Quality control/assurance 
12) ethics 
13) data handling and record keeping 
14) financing and insurance 
15) publication policy 
16) supplements 
Phase 1 
-intro of new drug/investigational product i...
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SOCRA Practice Test Questions And Answers 2022
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Which of the following is a disclosure of financial interests form? 
FDA Form 3455 
 
 
 
Which of the following is a certification of financial interest form? 
FDA Form 3454 
 
 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: 
FDA Form 3455 
 
 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial 
Investigational New Drug Application (1571) 
 
 
 
In the top right corner, form have OMB number. Wh...
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SOCRA- Sponsor Requirements Exam Questions & answers 100% Verified By Experts
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CRO- transfer of responsibility - ANSWER-Sponsor may transfer responsibility for any or all obligations to a contract research organization. It just needs to be in writing. 21 CFR 312 
 
1572 Form - ANSWER-Commitment of the investigator to sponsor to follow all regulations. 
 
Investigator Brochure - ANSWER-Summarizes the investigational drug, gives information on it (ie disposition, animal use, other clinical studies, etc.) and possible risks/precautions. 
 
IND Application- sections required b...
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SoCRA Certification Exam Questions With Answers Latest 2024-2025 | 100% Correct
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SoCRA Certification Exam Questions With Answers Latest | 100% Correct. 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. ...
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ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER- Try to obtain the subject's reason for withdr
- Exam (elaborations) • 19 pages • 2023
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ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE 
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER- Try to obtain the subject's reason for withdrawal. 
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - ANSWER- Validation, accuracy, reliability, completeness 
Part of a sponsor's responsibility pertaining to electronic...
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Good Clinical Practice (GCP) Questions and Answers | Latest Version | 2024/2025 | Already Passed
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Good Clinical Practice (GCP) Questions 
and Answers | Latest Version | 2024/2025 
 
| Already Passed 
 
1. **What are the three fundamental principles outlined in the Belmont Report?** 
Respect for Persons, Beneficence, Justice. 
 
2. **How can the Principle of Beneficence be implemented in a research study involving human 
participants?** 
By ensuring that the study maximizes potential benefits while minimizing possible risks. 
 
3. **What best encapsulates the principle of Respect for Persons ...
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