Socra ccrp test - Study guides, Class notes & Summaries

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...

CCRP SOCRA Study test in depth Examination and 100% correctly verified Solutions Latest version 2024/2025 Clinical Safety constitutes what ICH efficacy guidelines? - correct answer E1-E2F Good Clinical Practice constitutes what ICH efficacy guidelines? - correct answer E6 (ICH E6 GCP 1.21) What is the legal status of the International Committee on Harmonization? - correct answer While several countries have adopted ICH guidelines as laws, the US FDA adopted ICH only as guidance. The...

SOCRA CCRP Exam Guide Test. ADME - correct answer absorption, distribution, metabolism, excretion BA - correct answer bioavailability BE - correct answer bioequivalence CTA - correct answer clinical trial authority CTI - correct answer clinical trial investigator DMC - correct answer Data Monitoring Committee GLP - correct answer Good Laboratory Practices GMP - correct answer Good Manufacturing Practices PSUR - correct answer Periodic Safety Update Report IEC - correc...

CCRP SOCRA Exam test preparation Questions and Must have marking scheme Updated version 2024/2025 This form is used for the voluntary reporting of adverse events and product problems: A) 1571 B) 1572 C) 3500 D) 3500A - correct answer C) 3500 Reminder: 3500 is for voluntary; 3500A is for mandatory Each IRB that reviews studies involving children as subjects is covered by: A) 21CFR Part 56, Sub part A B) 21CFR Part 56, Sub part B C) 21CFR Part 50, Sub part C D) 21CFR Part 56, ...

SOCRA CCRP Exam Practice 100% Solved 21 CFR part 11 regulates? - ANSElectronic Signatures What is the name of FDA Form 483? - ANSInspectional Observation What does 21CFR56 regulate? - ANSInstitutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - ANS812 Define Electronic Signature - ANSA computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent ...

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...