Investigator site file-Expected documents

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    • March 31, 2021 at 6:00 pm #4067
      Ilaria Manzari
      Participant

      dear all,
      what do you expect fore investigator site file:

      – CSR: just the synopsis or full CSR?
      – GMP Manufacturer’s license, GMP Certificate, IP Verification Statements, Statement of GMP compliance: are they expected to be filed in the ISF?

      Thank you!
      Ilaria

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