50 cfr 21 Study guides, Class notes & Summaries

CCRP STUDY GUIDE EXAM . 21 CFR 11 - correct answer Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 - correct answer Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children 21 CFR 50 Subpar...

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...

CCRP SOCRA Exam - Practice Exam #1 (Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA) Passed Qs & As

CCRP 21 CFR and FDA Forms and Documentation Requirement Questions and Answers 2023/2024 21 CFR 50 - correct answer Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children 21 CFR 50 Subpart B - correct answer 50.25 Elements of Informed Consent 21...

CCRP Exam Graded A+ 21 CFR 11 - ANSElectronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 - ANSProtection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children 21 CFR 50 Subpart B - ANS50.25 Elements of Informed Cons...

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. Wh...

When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) How man...

SOCRA CCRP Exam Questions With 100% Correct Answers. April 30 1996 - correct answer ICH GCP Development Date Quality - correct answer ICH Q Efficacy - correct answer ICH E Safety - correct answer ICH S Multidisciplinary - correct answer ICH M guidance for industry, consolidated guideance - correct answer ICH E 6 Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A Safety pharmacology studies for human pharmaceuticals - correct answer ICH S7A ...

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...