What is gcp - Study guides, Class notes & Summaries

Good Clinical Practice ICH Questions and Answers | Latest Version | 2024/2025 | Already Passed What is the primary focus of Good Clinical Practice (GCP)? A) To ensure the efficacy of clinical trials B) To protect the rights and well-being of human subjects C) To streamline the regulatory approval process D) To reduce the costs of clinical research B) To protect the rights and well-being of human subjects Explanation: Good Clinical Practice (GCP) is an international standard t...

Snowflake Certification Cheat Sheet Exam Questions And Answers What is Snowflake? (key features) - ANS Analytic data warehouse SaaS offering - No hardware/installation/patching - No ongoing maintenance/tuning - Can't run privately (on-prem/hosted) Runs completely in the Cloud (AWS, Azure, GCP) - Has its own VPC Decoupled compute and storage (scaled compute does not need scaled storage) Snowflake Pricing (what determines unit cost, pricing model, editions features) - ANS...

The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (11T) c. Post market device registries d. outcome and health services research Who is ultimately responsible for all aspects of the research conducted at a site? a. IRB b. sponsor c. principal investigator d. clinic...

GCP- Social and Behavioral Research Best Practices for Clinical ResearchYou overhear someone say the following about Good Clinical Practice (GCP) in the hallway: "GCP is mostly just meant to curb abuses by unscrupulous researchers who make bad decisions in response to pressure to discover the next big thing." What could you say in response to this? - a. That's right; GCP are very rigorous rules that every researcher must follow - b. That's not quite right, because GCP is really more abou...

Practice Questions for SOCRA exam VERIFIED 2022/2023Which of the following is a disclosure of financial interests form? ... Which of the following is a certification of financial interest form? ... 00:27 01:29 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: ... This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Investigational New Drug Application In the top rig...

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...

PH 3114 - Good Clinical PracticeWhat is GCP? - correct answer Ethical and scientific quality standards for designing, conducting, recoding and reporting trials that involve participation of human subjects. It can be regarded as total quality management of clinical trials procedures Why is GCP needed? - correct answer To ensure that the rights, safety and wellbeing of the trial subjects are protected. Ensure the credibility of clinical trial data Why has GCP developed into formal guidelines...

A patient received an initial dose and had no initial reaction. The protocol says the patient needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - ANSWER 444mg^3/m Which countries are included in the ICH GCP? - ANSWER European Union, Japan, United States, Canada and Switzerland What is the monitor not responsible for? A) Patient information B) Sponsor SOP C) Protocol/ICF D) Reporting to IRB - ANSWER

Clinical TrainingWhat is Good Clinical Practice (GCP)? - correct answer A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical studies. GCP guidelines provide a framework for the fair, scientifically sound conduct of research studies involving human participants What is the purpose of the ICH GCP guidelines? - correct answer To ensure that the rights, safety, and confidentiality of participants in clinical trials are protected. T...

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...