Clinical Operations
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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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Virtual Clinical Trials: Best Practices in Moving Toward a Patient-Centric Research Model
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Regulatory Compliance
How to resolve irregularities in the documentation of informed consent?
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Ethics in Clinical Research
Can the IRB approve reimbursement of copays for routine costs in a clinical trial?
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Regulatory Compliance
Is IRB review required for survey results that may be published?
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Clinical Endpoints
Eliminating the Headache of Global Safety Reporting to Investigators and Ethics Committees
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Ethics in Clinical Research
Does the IRB need to review news stories?
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