SOCRA CCRP Study guides, Class notes & Summaries

A patient received an initial dose and had no initial reaction. The protocol says the patient needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - ANSWER-444mg^3/m Which countries are included in the ICH GCP? - ANSWER-European Union, Japan, United States, Canada and Switzerland What is the monitor not responsible for? A) Patient information B) Sponsor SOP C) Protocol/ICF D) Reporting to IRB - ANSWER- According to ICH E6, an inspection is define...

Timeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - respect for persons, beneficence, justice Application of Respect for Persons - informed consent (autonomy, choose for themselves) Application of Beneficence - risk/benefit analysis Application of Justice - appropriate selection of patients (equality) Language Level ICF - 6th-8th grade 8 basic elements of ICF - 1. purpose, duration, and procedu...

A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect Correct Answer 5, 15 IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation Correct Answer 3 Al IRB records need to be kept for ____ years follow completion of research Correct Answer 3 FDA will provide w...

Nuremberg Code (1947) Correct Answer 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 Correct Answer 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...

SOCRA CCRP ACTUAL EXAM 300 QUESTIONS AND CORRECT DETAILED ANSWERS TOP RATED VERSION FOR ALREADY A GRADED WITH EXPERT FEEDBACK|BRAND NEW|REVISED

Nuremberg Code (1947) - Correct Answer-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 - Correct Answer-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. r...

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 Electronic records, electronic signatures - Correct Answer-21 CFR Par...

Timeline of Historical Events - Correct Answer-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - Correct Answer-respect for persons, beneficence, justice Application of Respect for Persons - Correct Answer-informed consent (autonomy, choose for themselves) Application of Beneficence - Correct Answer-risk/benefit analysis Application of Justice - Correct Answer-appropriate selection of patients (equality) Language Level ICF...

Nuremburg Code - Correct Answer-The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - Correct Answer-1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjec...