CRDU Bahar Development Document

 

CRDU Bahar Development Document

 

The primary mission of the Clinical Research Development Unit (CRDU) - Bahar is to foster an environment conducive to high-quality, ethical, and innovative clinical research within our affiliated medical center. We are dedicated to supporting researchers through all phases of the research lifecycle, ensuring compliance with international regulatory standards and advancing patient care through evidence-based practice.

This mission is realized through several foundational pillars:

We aim to translate scientific hypotheses into tangible clinical studies, encouraging novel trial designs that address unmet medical needs. This includes promoting investigator-initiated trials (IITs) that challenge current standards of care.

The CRDU - Bahar commits to the highest standards of scientific methodology. This involves rigorous protocol review, meticulous execution, and robust statistical planning to ensure that research findings are valid, reliable, and capable of influencing clinical practice guidelines.

We serve as the central point of expertise for navigating complex national and international regulatory landscapes, including FDA regulations (where applicable), local Ministry of Health guidelines, and institutional policies. Proactive compliance management minimizes risk and ensures the ethical integrity of all conducted studies.

Ultimately, our research efforts must translate into measurable improvements in patient outcomes. We prioritize research that directly informs clinical decision-making, leading to safer, more effective therapeutic and diagnostic strategies.

To become a leading national center for clinical trial execution and translational research, recognized for our scientific rigor, operational excellence, and commitment to patient safety and public health impact.

We strive to be the preferred partner for pharmaceutical companies, academic consortia, and government health agencies seeking reliable sites for complex Phase I-IV clinical trials. This recognition will be measured by the volume and complexity of studies successfully initiated and completed annually.

Our vision extends beyond standard interventional trials. We aim to bridge the gap between basic science discoveries made in the laboratory and their application at the patient bedside, emphasizing translational pathways that rapidly incorporate bench findings into clinical protocols.

We will establish industry-leading metrics for trial start-up times, patient enrollment rates, and data query resolution efficiency. Our operational model will serve as a benchmark for other research units within the health system.

The outcomes derived from CRDU - Bahar studies will demonstrably contribute to improved population health metrics, particularly in areas relevant to the demographic served by our affiliated medical center (e.g., chronic disease management, infectious disease control).

The CRDU - Bahar provides comprehensive support across several key areas, structured to manage the entire research pipeline efficiently.

This function ensures that research ideas are scientifically sound and feasible before initiating regulatory processes.

Feasibility Assessment: Reviewing proposed study designs against institutional capacity, patient population availability, and resource allocation constraints.

Endpoint Definition: Assisting investigators in defining primary and secondary endpoints using validated scales, ensuring statistical power is appropriately addressed.

Sample Size Justification: Calculating necessary sample sizes based on expected effect sizes and desired statistical power. For example, for a two-sample t-test comparing means ($\mu_1, \mu_2$) with standard deviation ($\sigma$), the required sample size ($n$) per group is: [ n = \frac{2(\sigma(Z_{1-\alpha/2} + Z_{1-\beta}))^2}{(\mu_1 - \mu_2)^2} ]

Data Management Planning: Developing preliminary Case Report Form (CRF) specifications and database structure designs.

Document Preparation: Ensuring all submission documents (Informed Consent Forms (ICFs), recruitment materials, Investigator Brochures (IBs)) meet IRB criteria for clarity, accuracy, and ethical completeness.

Submission Management: Acting as the liaison between the Investigator and the Institutional Review Board (IRB) or Ethics Committee (EC), managing correspondence, and tracking approval timelines.

Adherence to national and international standards is non-negotiable. The CRDU - Bahar maintains a proactive compliance posture.

Training Mandate: Ensuring all research personnel complete mandatory International Council for Harmonisation (ICH) Good Clinical Practice (GCP) certification and periodic renewal.

Source Documentation Review (SDR): Implementing quality control checks on source documentation to verify data integrity and traceability back to the subject's medical record.

Policy Integration: Translating high-level institutional research policies into actionable Standard Operating Procedures (SOPs) for daily study execution.

Audit Preparedness: Conducting internal mock audits to ensure readiness for regulatory agency inspections (e.g., FDA) or sponsor monitoring visits.

Standardized procedures for the expedited reporting of Serious Adverse Events (SAEs) to the sponsor, IRB/EC, and regulatory authorities within mandated timelines (e.g., within 24 hours for life-threatening unpredicted events).

Operational excellence ensures studies progress on time and within budget.

Developing comprehensive site activation checklists covering essential documents (e.g., FDA Form 1572, CVs, Financial Disclosures), essential equipment readiness, and pharmacy coordination. Target activation timeline: 60 days post-IRB approval.

Targeted Screening: Utilizing internal electronic health record (EHR) data mining tools (while maintaining strict privacy protocols) to identify potential candidates based on pre-defined inclusion/exclusion criteria.

Retention Planning: Implementing subject-centric strategies, including clear communication schedules and minimizing unnecessary burden on participants to maintain high retention rates.

Electronic Data Capture (EDC): Managing the implementation and validation of EDC systems, ensuring data consistency and minimizing data entry errors.

Query Management: Tracking and resolving data queries efficiently. The target resolution rate for Level 1 (critical) queries is 95% within 7 business days.

Managing timely submission of progress reports, safety updates, and final study reports to all relevant stakeholders, ensuring all study materials are archived according to regulatory requirements (minimum of 25 years).

The CRDU - Bahar is a center for continuous professional development in clinical research.

Developing and delivering mandatory onboarding modules for new research staff, covering GCP, protocol-specific procedures, and local regulatory requirements.

Hosting regular seminars on emerging topics such as adaptive trial designs, decentralized clinical trials (DCTs), patient-reported outcomes (PROs), and advanced biostatistics.

Pairing junior faculty and residents with experienced investigators to foster a pipeline of new, grant-ready researchers committed to ethical practice.

Ensuring financial and material resources support high-impact research effectively.

Standardizing clinical trial budget templates and negotiation processes to ensure fair compensation for site services while maintaining cost-effectiveness for sponsors.

Tracking study expenditures against milestones to ensure financial transparency.

Managing scheduling and utilization of specialized research infrastructure, such as dedicated infusion chairs, research pharmacies, and laboratory processing suites, maximizing throughput efficiency.

The organizational structure is designed for clear lines of accountability and rapid decision-making.

Unit Director: Dr. sakineh kolahdozan - Responsible for strategic vision, budget oversight, and ultimate regulatory accountability.

Key Personnel:

Regulatory Affairs Manager: mr enayati rad - Oversees IRB submissions, amendments, and regulatory correspondence.

Contact Address:
Clinical Research Development Unit (CRDU) - Bahar hospital

All research activities conducted under the purview of CRDU - Bahar are centered on the protection of human subjects, informed consent, and the integrity of collected data. We maintain the highest ethical standards in all our endeavors.

The safety and well-being of every trial participant supersede the interests of the science or the sponsor. Procedures are in place for immediate notification and intervention upon discovery of any unforeseen risk.

The consent process is treated as an ongoing dialogue, not a one-time administrative step.

Process Verification: CRDU SOPs mandate verification that the subject understands the study procedures, risks, and voluntary nature of participation before signature. This often involves a "teach-back" method.

Updates: Subjects are promptly informed of any new risks or findings that might influence their willingness to continue participation.

We uphold the principle that data must accurately reflect clinical reality.

Falsification Prohibition: A zero-tolerance policy exists for the fabrication, falsification, or misrepresentation of research data.

Transparency in Reporting: The CRDU is committed to transparent reporting of all study outcomes, regardless of whether the results are positive, negative, or inconclusive, thereby preventing publication bias and ensuring the scientific record is complete.

All investigators and research staff are required to disclose any potential financial or professional conflicts of interest related to ongoing or planned studies. These disclosures are reviewed by the Unit Director and the IRB to ensure they do not bias research execution or interpretation.