Regulatory Compliance
Participant Recruitment
Does the IRB need to approve doctor-to-doctor letters?
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Regulatory Compliance
What are the IRB review requirements for human factors/usability testing?
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Clinical Trial Safety
Changes in Research: What are They and When do They Need to be Submitted to the IRB?
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FDA & ICH
Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
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Ethics in Clinical Research
Compensating Research Participants FAQ
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Ethics in Clinical Research
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?
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FDA & ICH
What documentation needs to be submitted to the IRB for an IND exemption request?
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Ethics in Clinical Research
Does research involving retrospective review of patient charts require IRB review?
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Ethics in Clinical Research
Save 456 Days in IRB Review With a Seamless, Coordinated Submission Process
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Ethics in Clinical Research