Clinical Operations
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Regulatory Compliance
Can we charge a subject for a diagnostic test not done as part of the IRB approved protocol?
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Is it ethical to pay subjects for referring friends to a clinical research site?
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Regulatory Compliance
How should a site document a missing signature on a HIPAA authorization form?
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Clinical Trial Operations
Preparing for Success: A Better Way to Manage the Feasibility Process
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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