The Clinical Research Domain

The Clinical Research Domain is defined in the IWF using 7 elements. These Elements align with the International Joint Task Force Harmonized Core Competency Framework for the Clinical Research Professional (2014). Due to the nature of Clinical Research activity there is some overlap between these Elements.

• Ethics, patient safety and clinical governance underpin the conduct of clinical research activity.

• Research Development and Regulation describes the relevant regulatory frameworks governing clinical research.

• Science is the pursuit and application of knowledge and understanding following a systematic methodology based on evidence.

• Research design is the overall strategic approach to integrating the different aspects of a study to effectively address the research question and defines the measures for collection and analysis.

• Clinical Studies Operations encompasses the regulatory frameworks and systems required for compliance and to facilitate efficient, safe & participant-focused research.

• Study and site management involves the effective deployment of roles and financial resources and procedural documentation required to assess, arrange and deliver a research study.

• Data management and informatics is a quality process for capture of data as part of delivery for a study and analysis which enables the research outcomes of the study to be determined. The power of biostatistics and informatics is reliant upon high quality data input at source and its management through a research workflow

• Communication and Relationships which actively seek to work across boundaries and involve investment to maintain relationships that enhance research delivery, including NHS engagement across all clinical specialties and care settings.