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
Financial Disclosure by Clinical Investigators Guide
When a sponsor submits a marketing application to the FDA, the agency does not evaluate the clinical data in isolation. It considers who conducted the studies and whether any financial relationships between those investigators and the sponsor coul
EU Clinical Trial Regulation CTR 536/2014 Guide
On 31 January 2022, Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR) became applicable across the European Union, replacing the Clinical Trials Directive 2001/20/EC. The CTR applies to all clinical trials on medicinal products for