Clinical Research Development Unit
Clinical Research Development Unit (CRDU) of Imam Hossein Hospital
Introduction
The Clinical Research Development Unit (CRDU) at Imam Hossein Hospital is established to foster a robust, ethical, and high-quality research environment, acting as a vital hub for translational and clinical science within the institution. Our primary goal is to bridge the gap between basic scientific discoveries and their practical application in patient care, ensuring that medical advancements rapidly translate into tangible benefits for our patient population and the broader medical community. The CRDU serves as the central administrative, consultative, and logistical nexus supporting all investigator-initiated and industry-sponsored clinical research conducted under the purview of Imam Hossein Hospital. This commitment is underpinned by adherence to the highest international standards of research conduct and integrity.
Mission Statement
To facilitate, support, and accelerate high-impact clinical research projects by providing essential infrastructure, expert consultation, standardized protocols, and rigorous ethical oversight, thereby improving patient outcomes and advancing medical knowledge. This mission is achieved through continuous professional development, meticulous adherence to regulatory frameworks, and the promotion of collaborative, multidisciplinary research efforts across all clinical specialties present at Imam Hossein Hospital. We aim to create an environment where methodological rigor meets clinical relevance.
Vision
To become a leading national center for clinical research excellence, recognized for its innovative methodologies, high volume of successful clinical trials, and substantial contribution to evidence-based medical practice. Our vision extends to achieving international recognition for specialized research areas, particularly those addressing endemic health challenges pertinent to our region, positioning Imam Hossein Hospital at the forefront of medical innovation and discovery.
Core Functions and Objectives:
The CRDU operates across five interconnected functional domains designed to streamline the research lifecycle from conception to publication and implementation.
1. Research Support Services
This function focuses on providing high-level technical and intellectual assistance to investigators to maximize the scientific validity and feasibility of their studies.
Study Design Consultation: Expert guidance on selecting appropriate research methodologies (e.g., Randomized Controlled Trials (RCTs), observational studies, pragmatic trials). This includes power calculations, sample size justification, randomization schemes, and blinding strategies.
Example Statistical Consideration (Power Calculation for a Two-Sample T-Test): [ n = \frac{(Z_{\alpha/2} + Z_{\beta})^2 (\sigma_1^2 + \sigma_2^2)}{\Delta^2} ] Where $n$ is the required sample size per group, $\Delta$ is the expected mean difference, and $\sigma^2$ represents the variance.
Statistical Analysis Planning (SAP): Development of comprehensive SAPs prior to database lock, defining primary and secondary endpoints, planned statistical tests, handling of missing data (e.g., Multiple Imputation techniques), and interpretation metrics.
Data Management Systems: Implementation and maintenance of secure, validated electronic data capture (EDC) systems compliant with 21 CFR Part 11 guidelines, ensuring data quality, integrity, and traceability.
Manuscript Preparation & Dissemination Support: Assistance with structuring manuscripts according to guidelines (e.g., CONSORT for trials, STROBE for observational studies), ensuring appropriate referencing, and supporting submission processes to peer-reviewed journals.
2. Protocol Development & Review
Ensuring that all proposed research is methodologically sound, resource-appropriate, and clearly documented before submission for ethical review.
Protocol Template Standardization: Development and mandatory use of standardized hospital protocol templates that incorporate all necessary operational and ethical documentation sections.
Feasibility Assessment: Conducting comprehensive assessments regarding investigator expertise, patient recruitment potential (prevalence and incidence data review), availability of necessary equipment, and budget alignment with proposed activities.
Data Collection Instrument Validation: Reviewing and, where necessary, validating data collection tools (case report forms, questionnaires) for clarity, completeness, and relevance to study objectives.
3. Ethical and Regulatory Compliance
This is a paramount function ensuring patient safety and adherence to the highest standards of research governance.
ICH-GCP Training Mandate: Ensuring all study personnel involved in interventional trials are certified in the latest version of the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) guidelines.
IRB Submission Management: Serving as the primary liaison between investigators and the Institutional Review Board (IRB). This includes pre-submission review to ensure completeness, accurate submission forms, and timely follow-up on queries raised by the Ethics Committee.
Adverse Event (AE) and Serious Adverse Event (SAE) Reporting: Establishing clear Standard Operating Procedures (SOPs) for the prompt identification, documentation, causality assessment, and reporting of AEs/SAEs to the IRB, regulatory authorities, and sponsors within specified timelines (e.g., 24 hours for fatal/life-threatening unanticipated SAEs).
Auditing and Monitoring: Conducting internal quality assurance checks and coordinating external monitoring visits to ensure ongoing compliance with the approved protocol, regulatory requirements, and data integrity maintenance.
4. Training and Capacity Building
Investing in the human capital necessary for sustainable research productivity.
Workshops and Seminars: Regular scheduled sessions covering topics such as proposal writing, statistical software utilization (e.g., R, SPSS, SAS), ethical considerations in vulnerable populations, and navigating grant application processes.
Mentorship Programs: Pairing junior clinical staff (residents, fellows, junior faculty) with senior, established clinical researchers to guide long-term research career development.
Research Fundamentals Courses: Mandatory introductory courses for all new clinical staff aspiring to be Principal Investigators (PIs) or sub-investigators.
5. Infrastructure Management
Maintaining the physical and technological environment conducive to world-class clinical trials.
Clinical Trial Pharmacy Coordination: Ensuring secure, compliant storage and dispensing mechanisms for investigational medicinal products (IMPs), including temperature monitoring and accountability records, synchronized with pharmacy SOPs.
Specimen Biorepository Oversight: Managing dedicated, monitored cold storage facilities for biological samples collected during trials, ensuring proper labeling, consent linkage, and chain of custody documentation.
Resource Scheduling: Managing the scheduling and accessibility of specialized equipment frequently utilized in clinical research, such as high-resolution scanners or specialized diagnostic units used solely for research protocols.
Areas of Research Focus (Examples):
The CRDU actively promotes and supports research that aligns with the hospital’s strategic clinical priorities and addresses significant public health needs. While supporting all appropriate research, emphasis is placed on the following areas:
Oncology and Cancer Therapeutics: Focused investigation into novel chemotherapy/immunotherapy regimens, biomarker discovery for personalized medicine in prevalent cancers (e.g., gastrointestinal, breast), and survivorship care research.
Infectious Diseases and Epidemiology: Conducting surveillance, outbreak investigation protocols, and Phase II/III trials for new antimicrobial agents and vaccine efficacy studies, particularly concerning hospital-acquired infections and emerging pathogens.
Cardiovascular Research: Studies focusing on risk factor modification, non-invasive diagnostic imaging techniques (e.g., advanced echocardiography utilization), and post-interventional care protocols for acute coronary syndromes and heart failure management.
Advanced Diagnostics and Imaging: Evaluating the utility and cost-effectiveness of new diagnostic tools (e.g., AI-assisted image reading, advanced molecular diagnostics) in routine clinical workflows to improve diagnostic speed and accuracy.
Patient Safety and Quality Improvement in Healthcare: Implementing and evaluating structured interventions aimed at reducing medical errors, improving medication reconciliation processes, and enhancing patient adherence to complex treatment regimens. Research in this area often involves implementation science methodologies.
Contact Information
All inquiries regarding research initiation, regulatory support, or general CRDU operations should be directed to the main office.
Address: Imam Hossein Hospital,
Phone: 32342000
Email:crdu@shmu.ac.ir
Concluding Note
The Clinical Research Development Unit (CRDU) is dedicated to supporting all faculty members and clinicians in translating their innovative ideas into meaningful clinical evidence that directly impacts patient care at Imam Hossein Hospital and beyond. We strongly encourage early engagement with the CRDU team to ensure research protocols are designed for success, compliance is maintained rigorously, and research resources are utilized efficiently. We invite collaboration across all departments, viewing every clinical challenge as a potential avenue for rigorous scientific inquiry and translational impact. Our success is measured by the quality and impact of the evidence we generate together.