Cardiology
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Clinical Trial Safety
What are the IRB Reporting Requirements for Adverse Events?
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Clinical Trial Safety
Do we need to submit safety events from another site to our IRB?
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Cell & Gene Therapy
How should we handle financial conflicts of interest in FDA-regulated clinical trials?
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FDA & ICH
What are the signature requirements for translated informed consent documents?
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Series: Ask the IRB & IBC Experts
Can participants be reconsented over the phone when an ICF is updated?
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FDA & ICH
What are the IRB submission requirements for observational studies?
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Questions on regulations for process development and purchased human cells
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Regulatory Compliance
What training documentation is required for conducting clinical research studies?
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What are ethical considerations for a trial with a pre-study washout period?
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