1.5.3.6 Documentation requirement for sample and material

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​​​A. Background & Definitions

to be added


B. Guidance & Expectations

Documentation requirements for samples and material :

  • ​trackable and properly documented​
  • defined storage
  • properly disposed
  • available for timely and proper conduct of study ​


C. Resources

to be added



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Next item: 1.5.3.7 Retained personnel records