Investigators brochure - Study guides, Class notes & Summaries

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 ...

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 ...

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 ...

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...

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...

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...

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...

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. ...

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...

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 ...