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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_NRC_02 NOV 2021
Dec-2021 EDA_GCP_PIR_CoviVax  COVID_VACC_1_NRC_02 Dec 2021
Dec-2021 EDA_GCP_PIR_CoviVax  COVID_VACC_1_NRC_08 & 09 Dec 2021
Dec-2021 EDA_GCP_PIR_CoviVax  COVID_VACC_1_NRC_20 Dec 2021
Feb-2022 EDA_GCP_PIR_EgyVax_SPHINX_ Al Manial Feb 2022
Apr.-2022 EDA_GCP_PIR_EgyVax_SPHINX _ Al Manial April 2022
Aug-2022 EDA_GCP_PIR_EgyVax_SPHINX_ Al Manial August 2022
Feb.-2023 EDA_GCP_PIR_EgyVax_SPHINX_ Al Manial Feb 2023
Mar-2024 EDA_GCP_PIR_Durvalumab_D910DC00001_EMERALD-2_Assuit Uni Mar 2024
Aug-2025 EDA_GCP_PIR_Durvalumab_D910DC00001_EMERALD-2_NLI Aug 2025
Jul-2024 EDA_GCP_PIR_MO42541_IMBRAVE_ AFSH July 2024
Sep-2025 EDA_GCP_PIR_MO42541_IMBRAVE_ AFSH Sep 2025
Aug-2024 EDA_GCP_PIR_Durvalumab_D910VC00001_EMERALD-3_ELRIAH Aug 2024
Jul-2025 EDA_GCP_PIR_Durvalumab_D910VC00001_EMERALD-3_NHTMRI July 2025
Aug-2025 EDA_GCP_PIR_APD334-202_ICRID_Aug 2025
Feb 2025 EDA_GCP_PIR_Guselkumab_FUZION CD_NHTMRI_Feb 2025
Oct 2024 EDA_GCP_PIR_Ocrelizumab_MN39159_Consonance_MASRI CRC_Ain Shams Uni_Oct 2024 
Dec 2025 EDA_GCP_PIR_Ocrelizumab_MN39159_Consonance_Alex CRC_31 Dec 2025 
Dec 2025 EDA_GCP_PIR_Ocrelizumab_MN39159_Consonance_MASRI CRC_Ain Shams Uni_16 Dec 2025
Oct 2025  EDA_GCP_PIR_Risankizumab_M16-066 _CRC Alex-oct 2025
Oct 2025  EDA_GCP_PIR_Risankizumab_M16-066 _AFSH_Oct 2025
Sept 2024 EDA GCP PIR MOM-M281-006 National Cancer In-Sept 2024
Jan 2025 EDA GCP PIR MOM-M281-006 OCUM Mansoura Uni_Jan 2025
Sept 2025 EDA GCP PIR MOM-M281-006 CRC Alex 23 Sep2
Feb 2026 EDA GCP PIR MOM-M281-006 Nasser Institute_Feb-2026

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