Regulatory Compliance
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
What training documentation is required for conducting clinical research studies?
Blog Posts
Regulatory Compliance
How to resolve irregularities in the documentation of informed consent?
Blog Posts
Regulatory Compliance
Is IRB review required for survey results that may be published?
Blog Posts
Regulatory Compliance