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Record Keeping Guidelines
Elements and Uses of a Repository
International Council for Harmonisation: Good Clinical Practice (ICH-GCP)
Investigational In Vitro Diagnostics (IVDs) utilized in Clinical Investigations of Therapeutic Products
FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations
Prisoners in Research
Waiver or Alteration of HIPAA Authorization
De-identified Data Sets
Certification Preparatory to Research
HIPAA

Guidance

Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

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HIPAA

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