Informed consent form icf - Study guides, Class notes & Summaries

SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE|2024 ICFANSWERAn informed consent form (ICF) is used to ensure everyone involved in clinical research is a willing participant, with full knowledge of the potential risks and benefits to the extent that this is possible. ICHANSWERThis International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an ...

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: AST 5-65 ALT 5-35 BUN 4-25 Creat 0.5-1.2...

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...

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, s...

CCRP Exam 2024 with 100%Correct Answers. How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answer5 working days How many members must sit on an IRB? correct answer5 How long must an IRB retain records per 21 CFR 56? correct answer3 years after completion of research What are the criteria for IRB approval of research? (7) correct answer1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subje...

Timeline of Historical Events Correct Answer: Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report Correct Answer: respect for persons, beneficence, justice Application of Respect for Persons Correct Answer: informed consent (autonomy, choose for themselves) Application of Beneficence Correct Answer: risk/benefit analysis Application of Justice Correct Answer: appropriate selection of patients (equality) Language Le...

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. purpose, duration, and procedu...

CCRP Exam 2024 with 100%Correct Answers. How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answer5 working days How many members must sit on an IRB? correct answer5 How long must an IRB retain records per 21 CFR 56? correct answer3 years after completion of research What are the criteria for IRB approval of research? (7) correct answer1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subj...

CCRP SOCRA Actual preparation test exam with Thorough and Correct Answers Updated 2024/2025 What is the purpose of the IRB/IEC? - correct answer Safeguard the rights, safety, and well-being of all trial subjects Which of the following should the investigator do FIRST if a Serious Adverse Event (SAE) occurs? - correct answer Inform the Sponsor per protocol and regulatory requirements According to ICH E6 Who must sign the Informed Consent Form (ICF)? - correct answer 1. The person who con...

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