Citi gcp training - Study guides, Class notes & Summaries

Citi Training GCP and Refresher Questions and Answers 100% correct Which of the following defines phase I research as it relates to non-clinical and other phases of research: Phase I research is the first phase of research after animal testing and helps define future phase II and III studies. Approximately how many subjects generally participate in phase I studies? 20-80 As the amount of adaptive study designs and multiple-arm protocols increases, researchers are now adding small...

Citi Training GCP and Refresher Exam Questions and answers, Rated A+ Which of the following defines phase I research as it relates to non-clinical and other phases of research: - -Phase I research is the first phase of research after animal testing and helps define future phase II and III studies. Approximately how many subjects generally participate in phase I studies? - -20-80 As the amount of adaptive study designs and multiple-arm protocols increases, researchers are now adding sm...

Which of the following defines phase I research as it relates to non-clinical and other phases of research: - Answer-Phase I research is the first phase of research after animal testing and helps define future phase II and III studies. Approximately how many subjects generally participate in phase I studies? - Answer-20-80 As the amount of adaptive study designs and multiple-arm protocols increases, researchers are now adding small cohorts of a diseased population to phase I studies to ass...

Citi Training GCP and Refresher Exam Questions with Correct Answers Which of the following defines phase I research as it relates to non-clinical and other phases of research: - Correct Answer Phase I research is the first phase of research after animal testing and helps define future phase II and III studies. Approximately how many subjects generally participate in phase I studies? - Correct Answer 20-80 As the amount of adaptive study designs and multiple-arm protocols increases, resear...

CITI Training Exam Review Questions With Complete Solutions Latest Update (Graded A+). What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases (human trials). *30 day process. What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV marketing phase. How long does th...

CITI Training 134 Questions With Complete Solutions Latest Updated 2024 (GRADED A+) What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this doc...

CITI Training 134 Questions With Complete Solutions Latest Update Score A+. What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document n...

CITI Training Exam Questions With Complete Solutions Latest Update (Score A+). What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases (human trials). *30 day process. What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV marketing phase. How long does the NDA su...

Social/Behavioral Research Training (CGood Clinical Practice (GCP) - ANSWER international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects Clinical Trial (NIH Def) - ANSWER Beyond just biomedical studies, Social and Behavioral interventions are now defined as clinical trials. Why implement GCP? - ANSWER - Protect participants - Prevent non-compliance issues - Yield quality data for reproduc...

Good Clinical Practice (GCP) - ANSWER international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects Clinical Trial (NIH Def) - ANSWER Beyond just biomedical studies, Social and Behavioral interventions are now defined as clinical trials. Why implement GCP? - ANSWER - Protect participants - Prevent non-compliance issues - Yield quality data for reproducible findings Sponsor - ANSWER - Re...