Report fda and irb - Study guides, Class notes & Summaries

Which of the following is a disclosure of financial interests form? - ANSWER-FDA Form 3455 Which of the following is a certification of financial interest form? - ANSWER-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER-FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER-Investigational New Drug Application (1571) In the top right corner, form hav...

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

CCRP EXAM | Questions and Correct Answers | Latest Update 2024/2025 | 100% PASS How many days does a sponsor have to report an emergency use of an IP to the FDA? - Answer -5 working days How many members must sit on an IRB? - Answer -5 How long must an IRB retain records per 21 CFR 56? - Answer -3 years after completion of research What are the criteria for IRB approval of research? (7) - Answer -1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated bene...

CCRP IRB, ICH and FDA Practice Guide Exam Question and answers 2023/2024 How many days does a sponsor have to report an emergency use of an IP to the FDA? - correct answer 5 working days How many members must sit on an IRB? - correct answer 5 How long must an IRB retain records per 21 CFR 56? - correct answer 3 years after completion of research What are the criteria for IRB approval of research? (7) - correct answer 1. Risks to subjects are minimized 2. Risks are reasonable in relati...

Which document demonstrates that the PI has the education, training, and experience to be an expert in the clinical investigation of the drug under investigation? - Curriculum Vitae (CV) Which activity does FDA believe can be done better through the use of remote monitoring? - Analyzing site performance metrics, and clinical data to identify trial sites that have poor performance or potential noncompliance What should a sponsor do when they discover a PI is not complying with the general in...

CCRP EXAM WITH VERIFIED QUESTIONS AND ANSWERS How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANS5 working days How many members must sit on an IRB? - ANS5 How long must an IRB retain records per 21 CFR 56? - ANS3 years after completion of research What are the criteria for IRB approval of research? (7) - ANS1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informe...

CCRP (Certified Clinical Research Professional) SOCRA Certification Problem set Exam Questions with all answers Correctly provided Latest 2024/2025 Minimal risk - correct answer the likelihood of harm is no greater than that encountered in daily life or during routine PE IDE (Investigational Device Exemption) - correct answer an approved IDE permits device to be shipped lawfully 21 CFR Part 312 vs 21 CFR Part 812 - correct answer 21 CFR Part 312 = FDA Form 1572, Serious Adverse Event 2...

DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH GUARANTEED PASS 2024 LATEST UPDATE The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report - Answer A During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical inv...

SOCRA CCRP Exam Questions and Answers Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report respect for persons, beneficence, justice Application of Respect for Persons informed consent (autonomy, choose for themselves) Application of Beneficence risk/benefit analysis Application of Justice appropriate selection of patients (equality) Language Level ICF 6th-8th grade 8 basic elements of ICF 1....

Good Clinical Practice Course (Medical Clinical Research)A primary purpose of the ICH is to: a. Require FDA registration of worldwide clinical trials. b. Minimize the need for redundant research. c. Require publication of negative trial results. d. Develop mandatory worldwide regulations for drug development. - correct answer b. Minimize the need for redundant research The ICH GCP guidelines: a. Require certification of clinical research sites and investigators b. Set standards for the ...