HRP Helpful Information
HRP Consulting Group provides the following sample documents and other resources to help the research community navigate various requirements and challenges. Please contact us (see sidebar) if there are any other topics you could use help with yourself or that you think would be helpful to the community at large.
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HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...