Clinical Trial Submission and Institutional Review Process at YSMU
Yerevan State Medical University (YSMU) is committed to ensuring that clinical trials conducted at YSMU, its university hospital complexes, and the Mikaelyan Institute of Surgery are organized in accordance with high standards of quality, transparency, ethical conduct, patient safety, and institutional compliance.
YSMU has established an internal institutional review and confirmation process for externally sponsored clinical trials. All applications submitted by Sponsors and Contract Research Organizations (CROs) are subject to review in accordance with YSMU’s internal regulations.
To allow sufficient time for a comprehensive institutional assessment and timely trial start-up, Sponsors and CROs are requested to submit their clinical trial applications and relevant documentation at least two (2) months before the planned Site Initiation Visit (SIV).
Institutional Review Process
Clinical trial applications are reviewed by the YSMU Institutional Review Board, which coordinates the institutional assessment process. Depending on the study and applicable requirements, the review process includes:
- Assessment of the feasibility of conducting the clinical trial at YSMU, its university hospital complexes, and/or the Mikaelyan Institute of Surgery;
- Preparation of an institutional Expert Opinion on the Feasibility of Conducting the Clinical Trial;
- Assessment of potential patient recruitment capacity and estimated availability of eligible study participants;
- Review of the proposed Clinical Trial Agreement (CTA) from clinical, legal, financial, organizational, and other relevant perspectives;
- Coordination of the application and review process by the YSMU Ethics Committee, as applicable;
- Facilitation of Sponsor/CRO feasibility and qualification visits to assess the available scientific and clinical infrastructure, facilities, equipment, data management capabilities, and overall trial conduct capacity;
- Coordination with relevant YSMU departments, hospital units, investigators, and other stakeholders involved in trial preparation and implementation.
The institutional review of clinical trial applications is a fee-based service. Information regarding the applicable review and administrative fees is provided to the Sponsor/CRO during the submission process.
Sponsors and CROs are encouraged to contact YSMU at an early stage of trial planning and site selection. Early engagement and timely submission facilitate a transparent and efficient review process, appropriate assessment of site and patient recruitment capacity, and timely resolution of contractual, financial, ethical, and operational matters.
Important: The planned SIV and study start-up timeline should take into consideration the completion of YSMU’s institutional review and confirmation process, applicable Ethics Committee review(s), contractual arrangements, and other required approvals. Submission of the clinical trial application at least two months before the anticipated SIV is therefore strongly recommended.
Contact Information
For further information regarding the clinical trial submission, institutional review, feasibility assessment, and confirmation process at YSMU, Sponsors and Contract Research Organizations (CROs) are welcome to contact the Clinical Research Coordination Unit of the YSMU Knowledge and Technology Transfer Office (KTTO).
Contact person: Head of the Knowledge and Technology Transfer Office (KTTO)
Email: ktto@ysmu.am
Alternative email: kttoofysmu@gmail.com
The Clinical Research Coordination Unit serves as a point of contact for Sponsors and CROs throughout the clinical trial submission and institutional review process and facilitates communication with the relevant YSMU structures and clinical facilities.