Fda reporting form 3500 - 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...

45 CFR 46 Subpart A - Correct Answer-"Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B - Correct Answer-Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C - Correct...

SAE - Serious Adverse Event: - results in death - is life threatening (patient was at risk of death at time of the event) - results in persistent or significant disability - congenital anomaly/birth defect Short Form - A document that states that the elements of informed consent have been presented orally to and understood by the participant or the participant's LAR. 4 components of short form - 1. A short form consent document 2. And oral presentation of the required elemen...

SOCRA CCRP Exam Questions With All Correct Answers FDA Part 11 - ANSWER electronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - ANSWER Food and Drugs, and ICF FDA Part 56 - ANSWER IRBs FDA Part 312 - ANSWER investigational new drug application FDA Part 812 - ANSWER investigational drug exemption FDA Form 482 - ANSWER Notice of inspection FDA...

Contract Research Organization - A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? - False-they must sign both What is FDA form 3454 - Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the B...

Socra CCRP EXAM 2022/2023 WITH 100% CORRECT ANSWERS Contract Research Organization -Answer - A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? -Answer - False-they must sign both What is FDA form 3454 -Answer - Certification Financial Interests and Arrangements of Clinical Inve...

45 CFR 46 Subpart A - Correct Answer-"Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B - Correct Answer-Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C - Correct...

Contract Research Organization A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? False-they must sign both What is FDA form 3454 Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the B...

45 CFR 46 Subpart A "Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C Additional protection for prison...

45 CFR 46 Subpart A - Correct Answer-"Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B - Correct Answer-Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C - Correct...