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Health Authority Requirements for Retention Period of Clinical Trial Specimens (Blood, Urine, Etc.)

  • 1.  Health Authority Requirements for Retention Period of Clinical Trial Specimens (Blood, Urine, Etc.)

    Posted 27-Jan-2021 19:54
    Please share the applicable regulations and/or guidance documents from the US FDA and ROW regarding the required retention period for clinical trial specimens such as blood, urine, etc. in support of an IND or NDA/BLA/MAA.

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    Aldwin Aldana
    Director, Clinical QA and GxP Compliance
    Cambridge MA
    United States
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