Irb member - Study guides, Class notes & Summaries

CCRP SOCRA Exam - Practice Exam 1 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, safety, or welfare of a subject B) P...

CCRP SOCRA Practice Exam 2024 Final questions and correct answers 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 - CORRECT ANSWER-C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 - CORRECT ANSWER-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...

ADR - Adverse Drug Reaction Audit - Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) 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 - Subjects & Researchers are unaware C...

Belmont Report and its principles - Correct answerWhich 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 a maximization of the benefits and a minimization of risks Which of the following are the three principles discussed in the Belmont Report? - Correct answer-respect for persons, beneficence, justice The Belmont Report's principle of respect for persons incorporates at le...

CCRP SOCRA Objective Assessment Guide Exam Questions and Already graded Solutions and Assured Satisfactions 2024/2025 An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than _ per year. - correct answer once Research may receive approval if there is a minority of the IRB members present at the convened meeting (T/F) - correct answer false Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of on...

SOCRA 2, Exam Review Questions and answers, rated A+ clinical investigation - -______means any experiment that involves a test article and one or more human subjects 5 working days - -If immediate use of the test article is not sufficient to obtain the independent determination typically required in order to preserve the life of the subject, documentation shall be submitted to the IRB within________after use of the test article. the president - -________can deem informed consent not n...

Module 3 Exam (CITI) - Questions with 100% Correct Answers Data are made anonymous by -Destroying all identifiers connected to the data. -Requiring all members of the research team to sign confidentiality agreements. -Keeping the key linking names to responses in a secure location. -Reporting data in aggregate form in publications resulting from the research. In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activ...

An example of an institutional COI is: - An industry sponsor pays for the construction of a new research laboratory at the organization The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - There may be bias by the peer reviewer as to the area of research During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: - Disclose their potential...

CCRP SOCRA Exam - Practice Exam Correctly Answered. 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 - correct answer C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 - correct answer 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...