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Regulatory Reports

EDA-GCP Public Inspection Reports (PIR) of Clinical Trial Site

EDA-GCP Public Inspection Reports (PIR) of Clinical Trial Site
A GCP Inspection Public Assessment Report is a summarised review report of a Good Clinical Practice (GCP) inspection that contains non-confidential information for public disclosure. It presents key findings, observations, conclusions, and the corrective and preventive actions which were implemented in response to the inspection, to promote transparency, accountability, and public confidence in the oversight and conduct of clinical trials.

 

Date Report
Nov-2021 EDA_GCP_PIR_CoviVax_COVID_VACC_1_02 Nov 2021
Dec-2021 EDA_GCP_PIR_CoviVax_COVID_VACC_1_02 Dec 2021
Dec-2021 EDA_GCP_PIR_CoviVax_COVID_VACC_1_08 & 09 Dec 2021
Dec-2021 EDA_GCP_PIR_CoviVax_COVID_VACC_1_20
Feb-2022 EDA_GCP_PIR_EgyVax_SPHINX Feb 2022
Apr.-2022 EDA_GCP_PIR_EgyVax_SPHINX April 2022
Aug-2022 EDA_GCP_PIR_EgyVax_SPHINX_August_2022
Feb.-2023 EDA_GCP_PIR_EgyVax_SPHINX Feb 2023
Mar-2024 EDA_GCP_PIR_Durvalumab_D910DC00001_EMERALD-_Mar 2024
Jul-2024 EDA_GCP_PIR_M042541IMBRAVE_July 2024
Aug-2024 EDA_GCP_PIR_Durvalumab_D910VC00001_EMERALD-3_Aug 2024
Jul-2025 EDA_GCP_PIR_Durvalumab_D910VC00001_EMERALD-3_July 2025
Jul-2025 EDA_GCP_PIR_4202-HEM-301_Hibiscus_Zagazig University Hospital_Jul 2025
Aug-2025 EDA_GCP_PIR_Durvalumab_D910DC00001_EMERALD-2_Aug 2025
Sep-2025 EDA_GCP_PIR_M042541_IMBRAVE_Sep 2025

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