Regulatory Compliance
Ethics in Clinical Research
Do parents need to accompany adolescents at each research-related office visit?
Blog Posts
FDA & ICH
When should a child assent form be used in a pediatric clinical trial?
Blog Posts
Clinical Trial Safety
What are IRB submission requirements for post marketing safety reports?
Blog Posts
Clinical Trial Safety
Submitting Deviations from a Sponsor’s Adverse Event Reporting Requirements to the IRB
Blog Posts
Ethics in Clinical Research
What are the requirements for parental permission (consent) in studies involving children?
Blog Posts
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