Clinical Research Unit

The Heart Center is an esteemed academic medical institution affiliated with Tel Aviv University. It comprises a team of first-class doctors and personnel who seamlessly merge cutting-edge medical care with clinical and basic research.

From time immemorial, medical research has been pivotal to understanding processes and developing innovative treatments and operations to enhance patient care. The Sheba Heart Center is renowned for its extensive research, exemplified by numerous publications in the world's leading medical press. 

Medical studies provide an invaluable opportunity for students, interns, and experts to broaden and deepen their knowledge and expertise in the field of medicine, with a specific focus on cardiology. Our researchers benefit from the support of a skilled team comprising doctors, nurses, and research secretaries.

Research at the Heart Center is a collaborative effort between researchers, pharmaceutical companies, and medical centers in Israel and abroad. The center is currently conducting studies in various phases, including the second, third, and fourth. Numerous esteemed international studies have been and continue to be conducted at the Heart Center, including studies by the prestigious American research institute – the National Institutes of Health (NIH).

The Heart Center actively participates in international medical research and holds a prestigious role in conducting studies, recruiting patients, filling out research proposals, and monitoring patients in accordance with the guidelines of the Ministry of Health, based on the procedure for medical experiments on humans, 

The Heart Center is an active partner in international medical research and holds a respected position in research management, patient recruitment, research form completion, and patient monitoring in accordance with the Ministry of Health guidelines. It follows the Standard Operating Procedures for Clinical Trials in Humans, based on the Public Health Regulations (Clinical Trials in Humans, 1980, and its amendments in 1999) and the Regulations for Medical Trials in Humans, January 2006. The center implements the principles of the Helsinki Declaration, according to GCP (Good Clinical Practice). The Heart Center has earned much praise for its ability to recruit patients for research and manage research projects.

Objectives of the Clinical Research Unit:

• To initiate clinical trials/studies
• Conduct feasibility assessments for research studies, including those involving innovative medical devices (e.g., Modern Equipment Division), according to specific research requirements, necessary human resources, tools and methods, pricing, and other relevant scientific studies conducted within the same period.
• Coordinate between different research bodies interested in conducting studies at the Heart Center and its units.
• Initiate, coordinate, assist, and support the submission of research studies for approval of the Helsinki Committee, contracting committee, research budget submission, and subsequent follow-up. 
• Train and prepare the appropriate team for specific research, including participation in research meetings.
• Allocate human resources and coordinate research studies across different units of the Heart Center.
• Assist in recruiting patients for research studies.
• Support research management at all stages.
• Assist in ongoing reporting to the Helsinki Committee on study progress, side effects, and the like.
• Assist in renewing approval by the Helsinki Committee.
• Coordinate all research studies within the Center in terms of human resources, appropriate timing, and patient recruitment priorities.
• Provide an environment conducive to research excellence.
• Monitor the performance of contract execution.
• Provide a platform for research projects for students, interns, and specialists.
• The team includes a senior cardiologist, a research physician, nurses, research coordinators, and medical secretaries.

The clinical research process:

• Feasibility test of the research with the Heart Center’s units and management.
• Checking the trial protocol and appendices, the course of the trial and its compliance with GCP and medical ethics guidelines.
• Checking the engagement contract with the company implementing the research.
• Submission of the trial protocol to the institutional Helsinki Committee.
• Reviewing the budgetary engagement contract for the study and coordinating the submission of the engagement contract to the hospital's engagement committee.
• Preparing a budget appendix for the study and submitting it to the engagement committee.
• Participation in Helsinki Committee.
• Participation in researchers’ meeting.
• After receiving approval of the Helsinki Committee for Research and the approval of the contractual agreement with a commercial company, holding the initiation visit by the contract research organization (CRO).
• Preparation of forms and guidelines for research by the research team.
• Receipt of study drugs/Medical Equipment Division.
• Training of the Center’s staff on the new research.
• Audits initiated by the contract research organization (CRO).
• Audits by the initiating company (Audit) or the US Food and Drug  Administration (FDA) or the European authority.
• Regular reporting of side effects in study patients (including side effects reported from other centers) to the Helsinki Committee and the study initiator.
• Submitting a request for research changes on behalf of the initiating company (Amendment) to the Helsinki Committee.
• Submitting changes to the research consent form to the Helsinki Committee, in accordance with the change in the research protocol.
• Submitting an update to the researcher's brochure to the Helsinki Committee.
• An annual report on the progress of the research to the Helsinki Committee, and a request to extend the validity of the research approval once a year.
• Upon completion of the study, report on the completion of the study to the Helsinki Committee.