Regulatory Compliance
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
Can we transfer patient data from our CTMS to our parent medical practice?
Blog Posts
FDA & ICH
Is This an Interventional Clinical Trial or Observational Study? How- and Why- It Is Important to Write Protocols That Make This Distinction Clear
Whitepapers
Ethics in Clinical Research