Home Forums General Discussion Forum Investigator site file-Expected documents

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    • #4067
      Ilaria Manzari

      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!

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