Socrates - Study guides, Class notes & Summaries

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

CCRP SoCRA Exam latest revised question with rationale answers

Which of the following is/are true of something which is objectively true? correct answers There is some non-arbitrary standard distinct from the individual making the claim that can be used to determine the truth/falsity of the claim. Unfortunately for Socrates, whenever he encountered other people who were regarded as 'wise men' and began to question them, it turned out that Socrates was not actually wiser than these other people (the poets understood their poetry better than Socrates did...

Well-structured ICH4801 Assignment 2 (ANSWERS) 2024 - DISTINCTION GUARANTEED. (DETAILED ANSWERS - DISTINCTION GUARANTEED!)..... Question 1 [40 marks] Question 1(a) (20 marks) – compulsory Read the extract titled, “Colonialism, coloniality and post-colonial Africa: a conceptual framework”, from chapter 7 of the prescribed book (Seroto, Davids & Wolhuter 2020) and then answer the questions that follows. Colonialism, coloniality and post-colonial Africa: a conceptual framework Post-coloni...

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...

SOCRA CCRP Exam Questions and answers, rated A+ April 30 1996 - -ICH GCP Development Date Quality - -ICH Q Efficacy - -ICH E Safety - -ICH S Multidisciplinary - -ICH M guidance for industry, consolidated guideance - -ICH E 6 Clinical Safety Data Management Definitions and Standards - -ICH E2A Safety pharmacology studies for human pharmaceuticals - -ICH S7A Electronic records, electronic signatures - -21 CFR Part 11 Informed Consent - -21 CFR Part 50 Financial Disclosures - -21 CFR P...

SOCRA CCRP Exam Questions and answers, rated A+ April 30 1996 - -ICH GCP Development Date Quality - -ICH Q Efficacy - -ICH E Safety - -ICH S Multidisciplinary - -ICH M guidance for industry, consolidated guideance - -ICH E 6 Clinical Safety Data Management Definitions and Standards - -ICH E2A Safety pharmacology studies for human pharmaceuticals - -ICH S7A Electronic records, electronic signatures - -21 CFR Part 11 Informed Consent - -21 CFR Part 50 Financial Disclosures - -21 CFR P...

SOCRA CCRP Exam Practice Questions and answers, VERIFIED/ 21 CFR part 11 regulates? - -Electronic Signatures What is the name of FDA Form 483? - -Inspectional Observation What does 21CFR56 regulate? - -Institutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - -812 Define Electronic Signature - -A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding...

SOCRA CCRP, Exam Review Questions and answers, rated A+ Phase 0 clinical trial (PK) Pharmokinetics and (PD) Pharmodynamics. Very small in #'s 1st in Humans -is it consumable for humans? - -Phase 0 clinical trial True or false: the federal food, drug, and cosmetic act is United States, federal law enacted by Congress? - -True True or false: the FD&C act can be found in the US code, which contains all general in permanent US laws beginning at 21 U.S.C.301? - -True Food, Drug, and C...

SOCRA Exam Questions & Answers, rated A+. Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - -False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified ...