ISO 14155 GCP: Medical Device Clinical Investigation
ISO 14155 Good Clinical Practice practice test for medical device clinical investigations.
10 Informed Consent Tips for Healthcare Professionals
TIPS: Informed Consent 10 Informed Consent Tips Every Healthcare and Research Professional Needs to Know Informed consent is not a signature on a form. It is an ongoing process of communication that ensures the person giving consent genuinely
HIPAA: The Impact on Clinical Research
TIPS: HIPAA and Clinical Research HIPAA in Clinical Research: 10 Practical Tips for Research Professionals Clinical research involves collecting and disclosing PHI in ways that fall outside standard treatment and payment activities. HIPAA's P
GCP/ICH Obligations: 12 Tips for Site Teams
ICH E6(R3) — effective July 2025 under EMA and published by FDA in September 2025 — is the most significant update to Good Clinical Practice in nearly three decades. While the guideline introduces a risk-proportionate, Quality by Design framework,
GCP/ICH Sponsors and Monitors: 15 Practice Questions
Under ICH E6(R3), the sponsor is the entity that takes ultimate responsibility for the initiation, management, and financing of a clinical trial. The monitor is the sponsor's representative at the site, responsible for verifying that the trial is