Regulatory
Participant Recruitment
Does the IRB need to approve doctor-to-doctor letters?
Blog Posts
Regulatory Compliance
What are the IRB review requirements for human factors/usability testing?
Blog Posts
Clinical Trial Safety
Changes in Research: What are They and When do They Need to be Submitted to the IRB?
Whitepapers
Clinical Endpoints
Do You Know Me?: The Subtle Distinction Between “Anonymous” and “De-identified” Data in Clinical Research
Whitepapers
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
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