45 cfr part 46 - Study guides, Class notes & Summaries

Electronic Records, Electronic Signatures - ANSWER-CFR Title 21: Part 11 Informed Consent - ANSWER-CFR Title 21: Part 50 Financial Disclosure - ANSWER-CFR Title 21: Part 54 Instiutional Review Board - ANSWER-CFR Title 21: Part 56 Investigational new Drug Application - ANSWER-CFR Title 21: 312 New Drug Application - ANSWER-CFR Title 21: 314 Investigational Device Exemption - ANSWER-CFR Title 21: 812 Pre- Market Approval of Medical Devices - ANSWER-CFR Title 21: 814 Protect...

Pharmacist mission improve public health through ensuring the safe, effective, and appropriate use of medications 4 main clinical pharmacy practice models pharmaceutical care MTM comprehensive med mgmt CDTM Morisky Questionnaire predictive adherence measurement tool - 1+ drugs in a regimen for a particular disease - screen for knowledge gaps and motivational issues Adherence Estimator Used only for individual drugs Pt Ed Materials Assessment (PEMAT) tool usa...

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...

The belmont report was formulated by? - Correct Answer The National Commission for the protection of human subjects in biomedical and behavioral research The revised common rule revised - Correct Answer 45 CFR 46 Subpart A HHS certification Institution Responsibilities - Correct Answer The Institution bears full responsibility for all research involving human subjects covered under its Assurance. For all HHS-conducted or supported research, all of the requirements of the HHS Regulations at...

Declaration of Helsinki - ANSWER-Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice generally follow the Declaration of Helsinki. 3 Principles Belmont Report - ANSWER-respect for persons (informed consent) beneficence (assess risks and benefits) justice (selection of subjects) Belmont Report - Commission considered: - ANSWER-1) Boundaries btw research and routine practice 2) Role of assessment of risk/benefit criteria in dete...

SOCRA EXAM Review Questions and answers, rated A+ EIR - -Establishment Inspection Report 21 CFR Part 11 - -Electronic records & electronic signatures 21 CFR Part 50 - -Protection of human subjects; general requirements of ICF; ICF if patient is in coma, life threatening conditions 21 CFR Part 56 - -IRB (Basic element of an IRB); (Memberships, role, etc) 21 CFR Part 312 - -Investigational New Drug (IND) application (requirements of IND); Requirements of expanded access or emergency use...

April 30 1996 - ICH GCP Development Date Quality - ICH Q Efficacy - ICH E Safety - ICH S Multidisciplinary - ICH M guidance for industry, consolidated guideance - ICH E 6 Clinical Safety Data Management Definitions and Standards - ICH E2A Safety pharmacology studies for human pharmaceuticals - ICH S7A Electronic records, electronic signatures - 21 CFR Part 11 Informed Consent - 21 CFR Part 50 Financial Disclosures - 21 CFR Part 54 ...

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...

Belmont Report (1979) ethical principles and guidelines for the protection of human subjects of research. respect for persons individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person A person capable of deliberation about personal goals and of acting under the direction of such deliberation Beneficence Do not harm and maximize possible benefits and minimize possible harms Justice 1) to...

Nuremberg Code (1947) - ANSWERA 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 - ANSWER1. 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...