Regulatory Compliance
Regulatory Compliance
How do I handle a deviation in the use of blood specimens collected outside the timeframe?
Blog Posts
Regulatory Compliance
Guidance on genomic research with deceased patients
Blog Posts
Regulatory Compliance
Can we charge a subject for a diagnostic test not done as part of the IRB approved protocol?
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
What are the signature requirements for translated informed consent documents?
Blog Posts
FDA & ICH
What are the IRB submission requirements for observational studies?
Blog Posts
Regulatory Compliance