Unit Introduction

The Faculty of Medicine Ain Shams Research Institute-Clinical Research Centre (MASRI-CRC) is dedicated to carry out clinical human research and committed to improve health outcomes and enhance the magnitude of high-quality clinical research.

The Faculty of Medicine’s initiative to establish a dedicated research institute started in 2016 and within a short period of time the special manifesto and specialized financial statement for the clinical research center was officially approved. The center was equipped to host clinical trials and, on the 29th April 2018, the CRC received the Egyptian Ministry of Health accreditation. This was followed by an official inauguration of the whole institute (MASRI) on 11^th Jan 2020.

MASRI-CRC has a mission to protect the rights, safety, dignity and well-being of research participants and facilitate and promote ethical research that is of potential benefit to participants, science and the society.

MASRI-CRC is well centered inside the facilities of Ain Shams University Hospitals and harmoniously integrated and collaborating with all departments. The university hospitals include around 350 ICU beds, 2000 inpatient beds, 70

surgical rooms, 33 endoscopies and 140 outpatients’ clinics with a catchment of around 1.5 million inpatients/year and 500,000 outpatients/year.

MASRI-CRC developed standard operating procedures (SOPs) including contract management, biological material transfer agreement (MTA), procedures in case of emergencies, archiving system, laboratories, and responsibilities of staff personnel.

MASRI-CRC assists all through the clinical trial pathway raising awareness about the importance of clinical trials, offering consultations about research design, contract management and conducting the clinical research. The CRC ensures that all trials are being conducted according to the GCP principles.

Activities:

Current clinical trials at MASRI-CRC

1. International multicenter clinical trials with pharmaceutical companies:
   • CTQJ230A12001
   • GBT440-031
   • GBT440-034
   • AGB002
   • CLEE011A3201C
   • CAIN457A2310
   • OBS15591
   • PHAR_SPASMO_001
   • M16-006 or M15-991

2. Investigator initiated clinical trials:
   • NCT03540212
   • NCT03903185
   • NCT03903289
   • Interaction with different research institutes for sharing and exchanging experience; National cancer institute and National hepatology institute.
   • The center assists researchers in conducting self-funded research.
   • MASRI-CRC is integrated and collaborates with other subunits in MASRI. The CRC assists the Molecular Genomic Unit in coordinating the sentinel surveillance for severe acute respiratory illness (SARI) in the Eastern Mediterranean Region (EMR) (NAMRU-3 grant in collaboration with WHO & US-CDC).