GCP inspection finding/reports to the investigators, sponsors and ethics committee from 2005-2016
kally stevens made this Informationsfreiheit request to European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice
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Dear European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:
GCP inspection finding reports and/ or notice of violation and/ or observations conducted in EU and Outside Europe from 2005-2016. I need these reports issued to clinical investigators, sponsors, CROs, and IRB/IEC.
I need these reports for my academic project as I am pursuing my masters in clinical research.
I would be very grateful to you.