Gcp 5 - Study guides, Class notes & Summaries

SOCRA EXAM PREP | 2023 Update | 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 presen...

GCP 5. SPONSOR EXAM LATEST UPDATE...

GCP 5. SPONSOR FINAL EXAM PREP QUESTIONS WITH COMPLETE SOLUTIONS. Who is responsible for implementing and maintaining quality assurance and quality control systems with the written SOPs to ensure proper conduct of clinical trial? - CORRECT ANSWER This is a responsibility of the sponsor. 5.1.1 What is the purpose of the sponsor's SOPs? - CORRECT ANSWER The SOPs ensure that the trials are conducted and that the data are generated, documented and reported in compliance with the protocol,...

ICH GCP for CCRC Exam Prep 543 Questions with verified Answers 2024 Graded A+. Adverse Drug Reaction (ADR) -correct answer-All noxious and unintended responses to a medicinal product related to any dose E6(R1) 1 -correct answer-Glossary of terms Adverse Event (AE) -correct answer-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--any unfavorabl...

GCP 5. SPONSOR

GCP 5. SPONSOR

ACRP CCRC Exam Prep Questions and answers 100% correctWhat are expected or possible consequences of over-estimation of recruitment potential? - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? Subject welfare When is the i...

SoCRA Certification Exam 2023 with complete answers Biometrics A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digi...

1A protocol that has been previously reviewed by the full IRB is always eligible for expedited review. A. TRUE B. FALSE - Answer-B. FALSE 1A serious adverse event (SAE) should be reported to the local IRB within what period of time after learning of the event? A. 5 days B. 2 weeks C. 24 hours D. Follow the local IRB reporting guidelines. - Answer-D. Follow the local IRB reporting guidelines. 1Essential documents collected for research projects may be audited or inspected for GCP complia...

GCP EXAM QUESTIONS AND ANSWERS 100% CORRECT What words are missing from the following in ICH GCP: The Sponsor should update the XXXX as significant new information becomes available? investigator's brochure Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs: sponsor According to ICH GCP section 8, what is the purpose of IRB/IEC composition? A. To document that the IRB/IEC is constituted in agreement with GCP ...