What is gcp - Study guides, Class notes & Summaries

According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site? a. CV of investigator and Clinical Trial Authorization (CTA) b. Ethics Committee Approval and signed protocol c. CTA and Ethics Committee Approval d. CTA, Ethics Committee Approval and signed protocol - ️️c. CTA and Ethics Committee Approval What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should indemnify (legal ...

What is Infrastructure as Code? CORRECT ANSWER You write and execute the code to define, deploy, update, and destroy your infrastructure What are the benefits of IaC? CORRECT ANSWER a. Automation -We can bring up the servers with one script and scale up and down based on our load with the same script. b. Reusability of the code - We can reuse the same code c. Versioning - We can check it into version control and we get versioning. Now we can see an incremental history of who changed what, ...

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

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...

Snowflake Certification Cheat Sheet Exam Questions and Answers 100% Solved What is Snowflake? (key features) 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) Unit costs ...

US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed Describe the purpose of a New Drug Application (NDA). The NDA is submitted to the FDA to request approval for marketing a new pharmaceutical in the U.S. What is the purpose of a combination product in regulatory terms? It involves two or more regulated components, such as a drug and device, that work together. Explain what an Orphan Drug Designation provides to a company. It grants incentives lik...

What is Infrastructure as Code? CORRECT ANSWER You write and execute the code to define, deploy, update, and destroy your infrastructure What are the benefits of IaC? CORRECT ANSWER a. AutomationWe can bring up the servers with one script and scale up and down based on our load with the same script. b. Reusability of the codeWe can reuse the same code c. VersioningWe can check it into version control and we get versioning. Now we can see an incremental history of who changed what, how is ou...

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 Research Questions and Answers | Latest Update | 2024/2025 | Already Passed What could you say in response to someone who says Good Clinical Practice (GCP) is mostly about curbing abuses by unscrupulous researchers? a. That's correct, GCP is all about strict rules b. That's not true, GCP is more focused on participant behavior c. It's true that GCP was developed to address concerns about unethical behavior, but it'...

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 ...