Investigator oversight - Study guides, Class notes & Summaries

Which of the following should be used to determine the extent and nature of monitoring? A. Purpose, drug type, and number of subjects B. Purpose, complexity, and endpoints of study C. Number of subjects, complexity, and length of study D. Complexity, drug type, and endpoints of study correct answer: C. Number of subjects, complexity, and length of study True or False: the clinical trial monitor must ensure that they are informing the FDA of any CRF entry error they find during the cou...

CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set Clinical Trial process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome Clinical event, measurable indicator, subject reported response Brainpower Read More Feasibility of a Study Assessment of resource needs, regulator requirements, and potential level of risk of ha...

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 ...

CRA ACRP Practice Exam Questions (2022/2023) w/ explanation A screening log is useful for determining which of the following? 1. trial reimbursement 2. subject IP compliance 3. active recruitment efforts 4. trends regarding evaluable subjects 1 and 3 only. E6 8.3.20 A screening log will provide evidence of an investigator's efforts to recruit subjects even if they are unable to identify subjects that meet entry criteria, which can help discriminate sites who are failing to make an effort t...

Quality Assurance (GCP) Questions and Answers 100% correct F. A, C, and E Protocol Monitors perform which of the following duties during the conduct of a trial: A. Verify the accuracy of reported trial data. B. Verify the financial statements of the research site. C. Verify that the site has the adequate resources to continue the trial. D. Verify that all research site staff has documentation of driver's licensure. E. Verify that participant rights and well-being is being protected. F. ...

Genetic Research in Human Populations (ID 6) Important Considerations in Genetic Research 1. Effects on Family Members - IRB Consideration: - ️ When conducting research that involves collecting biological specimens for genetic testing, the effects of findings on other family members is the most important issue for the IRB to consider. - Rationale: - While all issues are significant, the potential impact of research findings on family members takes precedence. 2. Biospecimen Use and D...

Pearl's Certified Clinical Research Associate Exam Study Guide – With Questions & Answers (100% Correct) Pearl's Certified Clinical Research Associate Exam Study Guide – With Questions & Answers (100% Correct) Research - ANSWER - The systematic study of materials and sources in order to establish facts and reach new conclusions. Ethical - ANSWER - Conforming to an established set of principles or accepted professional standards of conduct. Budget development - ANSWER - The pr...

CCRC Exam Verified 100% Correct!! Clinical Trial process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome Clinical event, measurable indicator, subject reported response Feasibility of a Study Assessment of resource needs, regulator requirements, and potential level of risk of harm for human subjects participating in study Necessary controls...

CFRA Flash Card 2 Exam 83 Questions with Verified Answers Administrative Panel on Laboratory Animal Care - CORRECT ANSWER handles the oversight of animal use in research projects ASSIST - CORRECT ANSWER NIH's online system for the preparation, submission and tracking of grant applications through G to NIH. Award - CORRECT ANSWER official document notifying the grantee and others that an award has been made and stating the terms and conditions of the award. Biosketch - CORRECT ANSWER...

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 ...