Gcp 5 - Study guides, Class notes & Summaries

SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug pr...

Google Associate Cloud Engineer Exam Questions and Answers 2024 What is the purpose of a VPC ? -Answer-Connects resources to each other and the internet. networks are ___ , subnets are ___ -Answer-global,regional How would you increase the size of a subnet? -Answer-expanding IP addresses What is the purpose of a pre-emptible VM? -Answer-permission to terminate if resources are needed elsewhere. Also very cheap What is cloud DNS -Answer-translates hosts name to address using google edge ...

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...

CRA interview exam questions & answers 2024/2025 ICH GCP Guidelines - ANSWERSSet standards for the design, conduct, monitoring and reporting of clinical research. ICH - International Council for Harmonization GCP - Good Clinical Practice This is important because it ensures the quality of the information collected What is an SAE and how is it reported? Name 3 SAE's - ANSWERSSerious Adverse Event that is 1. life threatening 2. results in death 3. Prolonged hospitalization 4. Disabili...

Good Clinical Practice (GCP) Why is GCP important? - correct answer GCP compliance provides public assurance that the rights, safety and well-being of human subjects involved in research are protected What are the goals of GCP? - correct answer 1. To protect the rights, safety and welfare of humans participating in research 2. To assure the quality, reliability and integrity of data collected 3. To provide standards and guidelines for the conduct of clinical research 4. Good Clinical...

What is Anthos? - ANSWER-Google Cloud's platform for the hybrid cloud, that's built on open source technologies, like Kubernetes. What 4 main types of services does GCP offer? - ANSWER-Compute, Storage, Big Data, and Machine Learning What are the benefits of cloud computing? - ANSWER-1. On-Demand Self Service 2. Broad Network Access i.e. access from anywhere 3. Resource Pooling providing share resources to customers 4. Rapid Elasticity get more resources quickly as needed 5. Measure...

1. What is Good Clinical Practice (GCP) ANS An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects 2. What does Good Clinical Practice assure ANS Assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. 3. What is the objectiv...

SOCRA - CCRP FDA and HHS Regulations and Disclosures Practice Exam Questions and Answers 2023/2024 Nuremberg Code (1947) - correct answer 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 - correct answer 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk ass...

CCRC Exam Prep Questions With 100% Correct Answers. What is an Adverse Event (AE) ? Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) What is an Adverse Drug Reaction (ADR)? All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) What is the definition of Severity? intensity What are t...

ACRP Exam Questions With Latest Solutions 2024 1. What is the purpose of ICH-GCP? a. To standardize the design, conduct, recording, and reporting of clinical trials b. To instruct clinicians as to how to conduct preclinical toxicology tests c. To ensure that subjects are treated with the best available therapy d. To increase the number of abbreviations used in clinical practice - answera 2. What is the purpose of the IRB/IEC? a. To help ensure that trials are conducted according to the ...