Investigator oversight - Study guides, Class notes & Summaries

CRA ACRP Practice Exam Questions w/ explanation Solved 100% Correct 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 - Answer ️️ -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 ar...

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 - ANSWER-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 to recruit from sites who have been unable to en...

Which document demonstrates that the PI has the education, training, and experience to be an expert in the clinical investigation of the drug under investigation? - Curriculum Vitae (CV) Which activity does FDA believe can be done better through the use of remote monitoring? - Analyzing site performance metrics, and clinical data to identify trial sites that have poor performance or potential noncompliance What should a sponsor do when they discover a PI is not complying with the general in...

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 correct anaswers 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 to recruit from sites who have been unab...

SOCRA CCRP Exam (2023/2024) Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report respect for persons, beneficence, justice Application of Respect for Persons informed consent (autonomy, choose for themselves) Application of Beneficence risk/benefit analysis Application of Justice appropriate selection of patients (equality) Language Level ICF 6th-8th grade 8 basic elements of ICF 1. purpose, ...

ICH GCP Section 5- Sponsor Questions and Answers 2024 The methods used to asure and control the quality of the trial should be proportionate to the risk inherent in the trial and the importance of the information collected. in a trial, the sponsor should avoid... unnecessary complexity, procedures, and data collection. during protocol development, the sponsor should identify processes and data that are critical to ensure humans subject protection and reliability of trial result...

HCF Investigator Assumptions - *General knowledge of the Health care Delivery System *Health plan policy and procedures relative to the delivery of services *Able to identify Red Flags, behaviors & indicators of health care fraud schemes Know applicable federal & state laws related to health care fraud *Law enforcement & regulatory agencies that have oversight responsibilities for HCF *Local & regional investigative groups that have similar interests Fraud, by it's very nature...

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...

Adverse event should be reported to the IRB, IRO, or HUC within - 72 hrs As the principal investigator, you are in charge of selecting and appointing a medical monitor for the clinical investigation program. Of the following, who would be the best person for the job - A nurse who has exp in areas of patient management and safety Informed consent is rooted in which one of the following ethical principles - Respect for autonomy Maxim, primum non nocere, is most closely associated with which e...

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...