Regulatory Compliance

Ethics in Clinical Research
The Role of IRBs in Research Oversight: Information for Potential Participants in Clinical Research
Whitepapers
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
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
Ethics in Clinical Research
Does research involving retrospective review of patient charts require IRB review?
Blog Posts
Ethics in Clinical Research