Data Unit, Translational Research, and Registries

Fazal Hussain,Mahmoud Aljurf,Saud Alhayli

doi:10.1007/978-3-030-82052-7_16

Fazal Hussain, Mahmoud Aljurf + Show 1 more

Open Access

https://doi.org/10.1007/978-3-030-82052-7_16

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Abstract

AbstractResearch is the only way to challenge the existing standards of care; a dynamic and multidimensional process encompassing innovative therapeutic modalities, techniques, and interventions to optimize outcomes and quality of life of cancer patients. Cancer research has emerged as one of the core competencies for the standardization, accreditation, and academic standing of any comprehensive cancer center. Data unit is the center of gravity and the hub of research and development (databases, registries, translational research, randomized control trials) in a quality cancer care facility. Quality assurance, ethical conduct, and monitoring of research are the hallmarks of a center of excellence in galvanizing the research efforts and optimizing the quality outcomes.

Highlights

Research is the core competency and the third most crucial pillar of any major cancer center, followed by patient care and teaching
The research unit serves as an institutional hub for initiation and registration of clinical trials by the clinicians/investigators, monitoring accrual to each protocol, budget negotiation, clinical trial agreements for research trials, and developing SOPS to facilitate centralized management of clinical studies
Research staff is responsible for designing Case Report Forms (CRFs), documentation, database designing, data entry, data validation, discrepancy management, adverse events reporting, and data extraction

Summary

Introduction

Research is the core competency and the third most crucial pillar of any major cancer center, followed by patient care and teaching. The research unit aims at providing the best possible quality care and a wide array of investigational therapeutic options to patients with highly advanced cancers, which would not be available otherwise. Research unit manages the design, conduct, approval, and analysis of research by providing comprehensive data management support to researchers as per the IPPs for efficient, quality, and statistically sound research outcomes as follows:

Results

Conclusion