About the Clinical Research Unit

 

The Clinical Research Unit (CRU) at Tzu Chi Hospital is a dedicated unit that supports the systematic, coordinated, safe, high-quality, and ethical conduct of clinical research in accordance with applicable standards and regulations. The CRU facilitates various stages of research, from feasibility assessment and study preparation to study conduct, monitoring, data and documentation management, study completion, and dissemination of research findings.

 

The CRU also plays an important role in developing the research and innovation ecosystem at Tzu Chi Hospital, including supporting precision medicine, genomic research, medical imaging, artificial intelligence, advanced therapies, and research conducted across the hospital's centers of excellence. Through professional and integrated research management, the CRU aims to generate high-quality scientific evidence, support the development of medical therapies and technologies, and contribute to improvements in healthcare quality and patient safety.

 

Scope of Research

 

• Phase I–IV Clinical Trials — Studies conducted to evaluate the safety, dosage, efficacy, and clinical benefits of medical interventions.
• Observational Studies & Registries — Studies based on the observation and analysis of patient data without altering routine clinical care.
• Investigator-Initiated Studies — Research initiated and managed by investigators or institutions.
• Industry-Sponsored Trials — Clinical studies sponsored by pharmaceutical, medical device, biotechnology, or other relevant industry partners.
• Medical Device Research — Studies evaluating the safety, performance, and clinical benefits of medical devices.
• Artificial Intelligence & Medical Imaging — Research involving AI technologies and medical imaging that requires clinical validation.
• Genomics & Biomarkers — Research aimed at supporting more personalized detection, diagnosis, and treatment.
• Advanced Therapy Medicinal Products (ATMPs) — Research involving cell therapy, tissue-based therapies, and gene therapy.
• Other Healthcare Innovations — Research involving various healthcare technologies and products in accordance with the institution's competencies, facilities, and applicable regulations.
   

Research Process
 

• Research Submission — Investigators, sponsors, or partners submit research proposals to the CRU for registration and preliminary review.
• Feasibility Assessment — The CRU assesses study feasibility based on study requirements, available resources, facilities, and site readiness.
• Ethics & Regulatory Approvals — Study documents are processed to obtain ethical and regulatory approvals in accordance with applicable requirements.
• Study Site Preparation — The CRU prepares the study site, documentation, and operational requirements prior to study initiation.
• Study Conduct — The study is conducted in accordance with the approved protocol through coordination among investigators, participants, relevant hospital units, sponsors, and Contract Research Organizations (CROs).
• Monitoring & Quality Control — Study activities are monitored to ensure protocol compliance, data quality, and participant safety.
• Study Close-Out — Upon study completion, final documentation, administrative requirements, and study archiving are completed.
• Publication & Dissemination — The CRU supports the analysis, publication, and dissemination of research findings in accordance with applicable requirements.
   

Research Participant Safety
 

• Informed Consent — Ensuring that participants receive clear information about the study objectives, procedures, potential benefits, risks, and their rights before agreeing to participate.
• Participant Safety Monitoring — Participants' health and safety are monitored throughout the study in accordance with the protocol and established monitoring plan.
• AE/SAE Management and Reporting — Adverse Events (AEs) and Serious Adverse Events (SAEs) are identified, managed, documented, and reported in accordance with applicable requirements.
• Personal Data Protection — Participants' identities, health information, and personal data are kept confidential and protected in accordance with applicable regulations.
• Emergency Preparedness — Mechanisms are in place for managing emergency conditions and coordinating with relevant clinical care units.
• Protocol Compliance — All research activities are conducted in accordance with the approved protocol, including the assessment and management of any protocol deviations.
• Participant Insurance and Compensation — Insurance coverage and/or compensation mechanisms are provided according to the type and risk of the study and applicable requirements.
   

Quality, Ethics & Compliance
 

All research activities conducted by the Clinical Research Unit (CRU) at Tzu Chi Hospital adhere to Good Clinical Practice (GCP), ethical principles for research, approved study protocols, applicable regulations, and the hospital's internal policies. These standards are implemented to ensure that every research study is conducted safely, ethically, systematically, with appropriate documentation, and in an accountable manner.
 

The CRU also implements a quality control system through research process monitoring, protocol compliance oversight, data and documentation management, handling of deviations, and preparedness for monitoring, audits, and inspections. Through this approach, the CRU is committed to protecting the safety and rights of research participants, maintaining data integrity and confidentiality, and ensuring the quality of research outcomes so that the studies generate reliable scientific evidence that contributes to the advancement of healthcare.
 

Clinical Research Unit Team

Dr. Dhiya Khoirunnisa
Clinical Research Manager