Clinical Operations
FDA & ICH
Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Blog Posts
Ethics in Clinical Research
Compensating Research Participants FAQ
Blog Posts
Reinventing Site Feasibility
Videos
Ethics in Clinical Research
Ask the Experts: When Do I Report a Protocol Deviation to the IRB? Do I Need To Report a Summary of Deviations at the Time of Continuing Review?
Blog Posts
FDA & ICH
What documentation needs to be submitted to the IRB for an IND exemption request?
Blog Posts
Cell & Gene Therapy
[Video] Institutional Biosafety Committee Review: Strategies to Secure Rapid IBC Approval for Human Gene Transfer Trials
Videos
IBC Review: Strategies to Secure Rapid IBC Approval for Human Gene Transfer Trials
Videos
Clinical Endpoints
Relieving the Safety Reporting Burden on Sites: 4 Takeaways
Articles
Ethics in Clinical Research
Does research involving retrospective review of patient charts require IRB review?
Blog Posts
Ethics in Clinical Research