Ib 483 - Study guides, Class notes & Summaries

CCRC EXAM SOLVED 100% CORRECT!! Protocols 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance 12) ethics 13) data handling and record keeping 14) financing and insurance 15) publication policy 16) supplements Phase 1 -intro of new drug/investigational product i...

Quizzes 1. What does the abbreviation COPD stand for? * Chronic obstructive pulmonary disease. Correct! 2. What does the abbreviation AAA stand for? * Abdominal aortic aneurysm 3. What does the abbreviation HA stand for? * Headache. Correct! 4. What does the abbreviation MOI stand for? * Mechanism of injury. 5. What does the abbreviation EtOH stand for? * Alcohol. (this is often used when describing someone who drinks, ex. Pt admits to daily EtOH consumption) 6. What does the abb...

Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed ...

CCRC Exam Questions and Answers 2023 Protocols 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance 12) ethics 13) data handling and record keeping 14) financing and insurance 15) publication policy 16) supplements Phase 1 -intro of new drug/investigational ...

EIR - ANSWER-Establishment Inspection Report 21 CFR Part 11 - ANSWER-Electronic records & electronic signatures 21 CFR Part 50 - ANSWER-Protection of human subjects; general requirements of ICF; ICF if patient is in coma, life threatening conditions 21 CFR Part 56 - ANSWER-IRB (Basic element of an IRB); (Memberships, role, etc) 21 CFR Part 312 - ANSWER-Investigational New Drug (IND) application (requirements of IND); Requirements of expanded access or emergency use; 1572 21 CFR Pa...

CITI - SoCRA - GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) 100% answers Which of the following lists the three principles included in the Belmont Report? Respect for Persons, Beneficence, Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of inf...

Quizzes 1. What does the abbreviation COPD stand for? * Chronic obstructive pulmonary disease. Correct! 2. What does the abbreviation AAA stand for? * Abdominal aortic aneurysm 3. What does the abbreviation HA stand for? * Headache. Correct! 4. What does the abbreviation MOI stand for? * Mechanism of injury. 5. What does the abbreviation EtOH stand for? * Alcohol. (this is often used when describing someone who drinks, ex. Pt admits to daily EtOH consumption) 6. What does the abb...

CCRC EXAM SOLVED 100% CORRECT!! Protocols 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance 12) ethics 13) data handling and record keeping 14) financing and insurance 15) publication policy 16) supplements Phase 1 -intro of new drug/investigational product i...

Quizzes 1. What does the abbreviation COPD stand for? * Chronic obstructive pulmonary disease. Correct! 2. What does the abbreviation AAA stand for? * Abdominal aortic aneurysm 3. What does the abbreviation HA stand for? * Headache. Correct! 4. What does the abbreviation MOI stand for? * Mechanism of injury. 5. What does the abbreviation EtOH stand for? * Alcohol. (this is often used when describing someone who drinks, ex. Pt admits to daily EtOH consumption) 6. What does the abb...