Socra ccrp stuvia - Study guides, Class notes & Summaries

April 30 1996 - ANSWERSICH GCP Development Date Quality - ANSWERSICH Q Efficacy - ANSWERSICH E Safety - ANSWERSICH S Multidisciplinary - ANSWERSICH M guidance for industry, consolidated guideance - ANSWERSICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWERSICH E2A Safety pharmacology studies for human pharmaceuticals - ANSWERSICH S7A Electronic records, electronic signatures - ANSWERS21 CFR Part 11 Informed Consent - ANSWERS21 CFR Part 50 Fina...

Declaration of Helsinki (1964, 1975) - ANSWER -Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) Good Clinical Practice (GCP) - ANSWER -ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of a clinical trial. Covers human rights, standards on trial conduct, roles and responsibilities (IRB, PI, sponsor, monitors). GCP v Declaration of Helinski - ANSWER -GCP lacks moral principles an...

April 30 1996 - ANSWER-ICH GCP Development Date Quality - ANSWER-ICH Q Efficacy - ANSWER-ICH E Safety - ANSWER-ICH S Multidisciplinary - ANSWER-ICH M guidance for industry, consolidated guideance - ANSWER-ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER-ICH E2A Safety pharmacology studies for human pharmaceuticals - ANSWER-ICH S7A Electronic records, electronic signatures - ANSWER-21 CFR Part 11 Informed Consent - ANSWER-21 CFR Part 50 Fina...

Quality - ANSWER -ICH Q Efficacy - ANSWER -ICH E Safety - ANSWER -ICH S Multidisciplinary - ANSWER -ICH M guidance for industry, consolidated guideance - ANSWER -ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER -ICH E2A Safety pharmacology studies for human pharmaceuticals - ANSWER -ICH S7A Electronic records, electronic signatures - ANSWER -21 CFR Part 11 Informed Consent - ANSWER -21 CFR Part 50 Financial Disclosures - ANSWER -21 CFR Part 54...

Nuremberg Code (1947) - 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 - 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 to end tria...

21 CFR Part 11 - ANSWERSElectronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - ANSWERSElectronic Records 21 CFR Part 11 Subpart C - ANSWERSElectronic Signatures 21 CFR Part 50 - ANSWERSProtection of Human Subjects 21 CFR Part 50 Subpart B - ANSWERSInformed Consent of Human Subjects 21 CFR Part 50 Subpart D - ANSWERSAdditional Safeguards for Children in Clinical Investigations 21 CFR Part 56 - ANSWERSInstitutional Review Board 21 CFR Part 56 Subpart B - ANSWERSO...

Nuremburg Code elements - 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. subjects can withdraw 10. research must end the study if there is probable cause that continuing would lead to injury, disabil...

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

When was the Nuremberg Code created? - ANSWER-1947 What did the Nuremberg Code establish? - ANSWER-Worldwide requirement for informed consent with properly formulated experimentation with beneficence towards participants. When was Belmont report established? - ANSWER-1979 What does the Belmont report do? - ANSWER-- Establish boundaries between practice and research - created ethical principles: Respect for persons, Beneficence, and Justice - ensure applications of informed consent, ri...