Regulatory Compliance
Ethics in Clinical Research
Compensating Research Participants FAQ
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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?
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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
Case Studies
Ethics in Clinical Research
Do parents need to accompany adolescents at each research-related office visit?
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FDA & ICH
When should a child assent form be used in a pediatric clinical trial?
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Clinical Trial Safety
What are IRB submission requirements for post marketing safety reports?
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Clinical Trial Safety
Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB
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Ethics in Clinical Research