Irb law - Study guides, Class notes & Summaries

ACRP CCRC, CCRC Study Set Already Graded A+ ADR Adverse Drug Reaction Audit Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Brainpower Audit Certificate Confirmation audit took place Audit Report Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail Documentation of audit events Single Blind Study Subjects Unaware Double Blind Study ...

IRB – Law Practice Exam Questions Answers. Which of the following are the three principles discussed in the Belmont Report? A. IRB review, Federal regulations, Declaration of Helsinki. B. Informed Consent, Institutional Assurance, Researcher responsibility. C. Privacy, Confidentiality, Equitable selection of subjects. D. Respect for Persons, Beneficence, Justice. - CORRECT ANSWER D. Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle o...

CITI GCP Training Questions and Answers | Latest Version | 2024/2025 | 100% Verified The International Council for Harmonisation (ICH) guideline E6 has more extensive requirements for maintaining confidentiality of medical records and granting access to third parties compared to the FDA and HHS. According to the ICH E6 guideline, investigators must: Clearly disclose to participants in the informed consent form that the monitor, auditor, Institutional Review Board (IRB)/Independent ...

CITI training responsible conduct, RCR, Law, HTH 408 IRB (Answered) 100% score According to the U.S. Federal Research Misconduct Policy, fabrication involves: Making up data or results and recording or reporting them. Which of the following is most likely to be considered plagiarism? Using materials from a source without proper citation. Which of the following is the most effective strategy for preventing research misconduct? Good mentoring Which of the following is true regarding...

Biometrics - ANSWER 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 - ANSWER 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) Digital Signature - ANSWER An electronic signatur...

CITI Ethics, Responsible Conduct, RCR, Law, HTH And IRB Test Questions and Answers – Latest 2023/2024 (Verified Answers) 100% Correct Which of the following is true regarding data analysis? Data analysis methods should be specified in advance before a study begins. Which of the following most accurately describes data lifecycle management (DLM) It refers to the tools and processes for handling data during a research study and after it concludes. Which of the following is true regarding the rep...

Adverse Drug Reaction (ADR) - Answer In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Adverse Event (AE) - Answer Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have...

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 ...

21 CFR 50 - Protection of Human Subjects Sponsor - a person who initiates a clinical investigation, but who does not actually conduct the investigation Sponsor-investigator - an individual who both initiates and actually conducts (alone or with others) a clinical investigation Human subject - an individual who is or becomes a participant in research, either as a recipient of the test article or as a control Institution - any public or private entity or agency Institutional Review Board (...

SOCRA Practice Test with 100% Correct Solutions Which of the following is a disclosure of financial interests form? -Answer-FDA Form 3455 Which of the following is a certification of financial interest form? -Answer-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: -Answer-FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Answer-Investigational New Drug Application...