Regulatory Affairs and Ethics are foundational to the design, approval, conduct, and monitoring of clinical trials. This domain ensures that research is conducted in compliance with national and international regulations, safeguarding participant safety, data integrity, and scientific validity.
Key Sub-Tracks: Clinical Trial Regulations · Informed Consent Process · Ethics Committee & IRB Review · Good Clinical Practice (GCP) Guidelines · Data Privacy and Confidentiality (e.g., GDPR, HIPAA) · Regulatory Submissions (FDA, EMA, CDSCO) · Post-Marketing Requirements · Risk-Benefit Assessment · Patient Advocacy and Protection · Pharmacovigilance Compliance · Investigator Obligations · Cross-Border Regulatory Harmonization · Adverse Event Reporting Standards · Audits and Inspections · Digital Health and Regulatory Compliance
