Regulatory Compliance
Regulatory Compliance
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators
Blog Posts
Regulatory Compliance
Cancer Clinical Trial Eligibility Criteria: Performance Status Guidance for Industry, IRB, and Clinical Investigators
Blog Posts
Regulatory Compliance
Why do Community Members Need to Participate in IBC Review Meetings?
Blog Posts
Ethics in Clinical Research
Demystifying FDA Processes: Why Do Changes in Regulations Take so Long?
Blog Posts
Ethics in Clinical Research
Review of Emergency Research
Whitepapers
Diversity & Inclusion
FDA Guidance and Revised OMB Guidance on the Collection of Race and Ethnicity Data
Blog Posts
Clinical Trial Safety
When to Use a DMC, EAC, or Both
Case Studies
Ethics in Clinical Research
Ask the Experts: What Is E-consent? What Are E-signatures?
Blog Posts
Ethics in Clinical Research
Revisiting the FDA’s Proposed Single IRB Mandate: Navigating Changes and Aligning for Success
Videos
FDA & ICH