Info 482 Study guides, Class notes & Summaries

BESTQUIZZES COMPREHENSIVE EXIT EXAM – PRIORITY ONE 1. A nurse is assessing a client’s pulmonary artery wedge pressure (PAWP). The nurse should recognize that an elevated PAWP indicates which of the following complications? A. Left ventricular failure B. Cardiogenic shock C. Hypovolemia D. Hypotension 2. A nursing planning care for a school-age child who is 4 hr postoperative following perforated appendicitis. Which of the following actions should the nurse include in the plan ...

CCRC Exam Questions And Answers Protocols - ANS 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 - ANS -intro of new drug/inve...

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...

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 ...

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...

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 ...

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...

Socra exam-Forms and Device info 100% SOLVED Form 3454-Financial Interest Certification - ANSWhat form is used for the certification of financial interest and arrangements of clinical investigators? Form 482-Notice of inspection - ANSWhat form is used for the reporting of an upcoming inspection or audit? Form 483-Inspectional Observations - ANSWhat form is used for the reporting of audit/inspection findings? Form 3500-Voluntary AE and product problem report - ANSWhat form is used for th...

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...

SOCRA Practice 1 questions and answers latest 2023 True or False The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) is sponsored by a licensed medical practitioner who becomes a sponsored investigator. 21 CRF 312.35 True or False Investigators are responsible for periodically requesting updates regarding new information gleaned by a ...