Clinical Research: Bioethics, Regulation and Good Clinical Practices — High Specialty Treaty

Research Methodology · Clinical Bases

How it begins

Un tratado exhaustivo y analítico sobre los principios fundamentales de la bioética médica, la evolución histórica de las normativas internacionales, los rigurosos procesos de aprobación de nuevos fármacos bajo ICH-GCP, el control de la integridad de datos bajo ALCOA+, y los marcos legislativos de la FDA y la EMA.

What it covers

1. Epistemology and History of Human Experimentation: From Blind Empiricism to Rigorous Method
2. The Nuremberg Trials and the First Code of Ethics: The Sentence of the Doctors
3. The Declaration of Helsinki: Evolution, Revisions and the Global Ethics of the WMA
4. The Belmont Report and the Fundamental Bioethical Principles: The Legacy of Tuskegee
5. The Menlo Report: Bioethics applied to Information and Communication Technologies
6. CIOMS Guidelines: International Ethical Guidelines in Low Resource Settings
7. Informed Consent: Doctrine, Understanding and Vulnerability of the Subject
8. Research Ethics Committees (CEI / CEIm): Composition, Powers and Operation
9. · Attributions and continuous evaluation process
10. Conflicts of Interest, Publication Bias and Intellectual Integrity
11. ICH-GCP E6(R2) and ICH E6(R3): The Global Standardization of Surgical-Pharmaceutical Quality
12. · The imminent modernization under ICH E6(R3)
13. The Clinical Research Protocol: Surgical-Methodological Design and Advanced Statistics
14. · The structure of randomization and masking
15. Clinical Phases of Clinical Development: The Long Pharmacological Road
16. The Investigator's Manual (Investigator's Brochure): Technical and Security Architecture
17. Data Management and Electronic Data Collection Notebook (eCRF): The Digital Transition
18. Clinical Monitoring and Risk-Based Quality Management (Risk-Based Monitoring - RBM)
19. · Analytical components of a modern monitoring plan
20. Pharmacovigilance of Clinical Trials: Adverse Events, SAEs and SUSARs
21. Data Integrity: The ALCOA+ Framework and the Preparation of Regulatory Inspections
22. Regulation in the USA: FDA, Investigational New Drug (IND) and New Drug Application (NDA)
23. Regulation in the European Union: The CTR Regulation 536/2014 and the CTIS System
24. · Computer centralization through the CTIS
25. Regulation of Health Products and Medical Devices: The Framework of the ISO 14155 Standard
26. · The risk classification of the product and its methodological impact
27. Research in Special Populations: Pediatrics, Obstetrics and Geriatrics
28. Biobanks, Genomics and Research with Human Biological Material: The Taipei Declaration
29. · The ethical governance of biobanks
30. Big Data, Artificial Intelligence and Algorithms in Future Research
31. · Regulation of AI as a Health Product (Software as a Medical Device - SaMD)
32. Protocol Deviations, Scientific Fraud and Retractions: The Breakdown of Trust
33. · The distinction between Protocol Deviations and Misconduct
34. Decentralized Clinical Trials (DCT) and Methodological Innovation: Adaptive Designs
35. · The methodological science of Adaptive Designs
36. Bioethics in Health Emergency Situations and Pandemics: Regulatory Acceleration
37. · Controlled regulatory acceleration mechanisms