What is 45 cfr part 46 - Study guides, Class notes & Summaries

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...

45 CFR 46 Subpart A "Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C Additional protection for prison...

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) Purported or represented to be...

Good Clinical Practice Test Questions and Answers Latest Updated Which of the following are the three principles included in the Belmont Report? • Respect for Persons • Beneficence • Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? • Determining that the study has maximized benefits and minimized risks. * The Belmont Report's principle of beneficence includes the two general rules as compl...

SOCRA CCRP Exam Questions and Answers 2023 April 30 1996 ICH GCP Development Date Quality ICH Q Efficacy ICH E Safety ICH S Multidisciplinary ICH M guidance for industry, consolidated guideance ICH E 6 Clinical Safety Data Management Definitions and Standards ICH E2A Safety pharmacology studies for human pharmaceuticals ICH S7A Electronic records, electronic signatures 21 CFR Part 11 Informed Consent 21 CFR Part 50 ...

What was the predecessor to the Constitution? Articles of Confederation Where are Federal-Level laws enacted? Congress What Article, Section and Clause empowers Congress to collect taxes Article 1, Section 8, Clause 1 What occurs when the President does not sign an enrolled bull within 10 days? Pocket Veto Which branch of government implements laws? Executive Approximately what percent of federal spending is discretionary? 30% How frequently does congress review the DoD budget reques...

1 AIC EXAM | QUESTIONS & ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+ In addition to the title of the meeting, the date, time and location it occurred, what are the other important items to include in a meeting minutes? Correct Answer: List of attendees and who needs to receive a copy of the minutes. Clear and unbiased summary of the major points, discussions, and decisions made. Action items with responsibility and due dates. Which of the following documents is used by a Contra...

1 AVIATION SAFETY EXAM | QUESTIONS & ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+ List three strategic objectives of ICAO and discuss their importance in international aviation. Correct Answer: 1) Transparency and sharing of safety information 2) Greater involvement of regional safety organization 3) Increased cooperation between regulators and industry stakeholders - The ICAO is important to international aviation in that they are the organization tasked with the safety, secur...

1 ASSOCIATE CONSTRUCTOR EXAM | QUESTIONS & ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+ AIC Stands For? Correct Answer: American Institute of Constructors AICCCC Stands For? Correct Answer: AIC Constructor Certification Commission Associate Constructor Exam an individual will be awarded the _______ credential. Correct Answer: Associate Constructor (AC) Associate Constructors can only maintain their designation for ____ years. Correct Answer: 10 Oral communication is the exchange...

1 AIC EXAM | QUESTIONS & ANSWERS (VERIFIED) | LATEST UPDATE | GRADED A+ . What percentage of conversations do listeners remember of what they hear? A. 10% B. 30% C. 50% D. 90% Correct Answer: 10% What percentage of conversations do speakers remember of what they say and do? A. 30% B. 50% C. 70% D. 90% Correct Answer: 90% 2 When giving presentations, people should do which of the following? A. present extra information beyond their primary goal to demonstrate their expe...