Certified Clinical Research Professional Ex Guías de estudio, Notas de estudios & Resúmenes

How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answers 5 working days How many members must sit on an IRB? correct answers 5 How long must an IRB retain records per 21 CFR 56? correct answers 3 years after completion of research What are the criteria for IRB approval of research? (7) correct answers 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed...

When isn't an IND application needed? correct answers IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) correct answers FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional information (drug dependenc...

Certified Clinical Research Professional (CCRP) Exam with question and answer verified 2023When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human resea...

Certified Clinical Research Professional (CCRP) Exam (Latest 2023/2024) Download to Score A