Regulatory Compliance
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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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FDA & ICH
What are the IRB submission requirements for observational studies?
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Regulatory Compliance
What training documentation is required for conducting clinical research studies?
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Regulatory Compliance
How to resolve irregularities in the documentation of informed consent?
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Regulatory Compliance
Is IRB review required for survey results that may be published?
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Regulatory Compliance
Can we transfer patient data from our CTMS to our parent medical practice?
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FDA & ICH