The Ethiopia Food and Regulatory Authority (EFDA) pharmacovigilance and clinical trial authorization unit conducted an inspection of the PREGART clinical trial implementation (GCP inspection) from December 26-28 /2022. The inspection objective was to ensure the trial implementation compliance with the regulatory authority guidelines for good clinical practice (GCP). The inspection was conducted after a week of the notification by two inspectors. The inspection started with an opening meeting whereby the inspectors described the purpose, methods, and procedures for the inspection. During the inspection process, the inspectors verified the trial is conducted in compliance with the granted authorization, the approved trial protocol, and good clinical practice (GCP) by carrying out observation of the trial and participants’ documents, observation of trial facilities, and interviewing study staff and investigators. After the end of the inspection, an exit meeting was conducted in the presence of investigators, study clinicians, and Hawassa University research directorate representatives. The inspectors explained their comments and feedback on their observations pending the formal inspection report after two weeks.

Trial hospital staff with the regulatory authority inspectors (from left to right, 4th & 5th are EFDA inspectors)


EFDA inspectors and trial staffs exit meeting partly