Principal Investigator
Regulatory Compliance
Guidance on genomic research with deceased patients
Blog Posts
What is the IRB’s responsibility for the review of updated Investigator Brochures?
Blog Posts
Ethics in Clinical Research
If a Subject’s Care Is Divided Equally Between Two Caregivers, Who Should Sign Caregiver Consent?
Blog Posts
Regulatory Compliance
Can we charge a subject for a diagnostic test not done as part of the IRB approved protocol?
Blog Posts
Is it ethical to pay subjects for referring friends to a clinical research site?
Blog Posts
Regulatory Compliance
How should a site document a missing signature on a HIPAA authorization form?
Blog Posts
Clinical Trial Safety
What are the IRB Reporting Requirements for Adverse Events?
Blog Posts
Clinical Trial Safety
Do we need to submit safety events from another site to our IRB?
Blog Posts
Cell & Gene Therapy
How should we handle financial conflicts of interest in FDA-regulated clinical trials?
Blog Posts
FDA & ICH