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Quality Management System

 

The Quality Management System (QMS) at HRB-HRB CRF-C supports the delivery of Clinical Research to the highest standards of research and clinical governance, ensuring:

  • The rights, safety and well being of trial subjects are protected
  • Quality and safety considerations are embedded throughout the Facility
  • A culture of continual assessment and quality improvement is promoted.

 

The Clinical Research Facility has documented and maintained a quality management system in accordance with the requirements of International Conference Harmonisation Good Clinical Practice (ICHGCP) Guidelines and all applicable regulatory requirements.  Processes are described in Standard operating procedures under the following headings:  Quality, Clinical, Data Management, Statistics Pharmacovigilance, Administration, and Business development.

 

The QMS incorporates risk assessment and risk management and mitigation into its key processes. SOPs re Change control, non-conformance, staff training, management of equipment, validation of computer systems, vendor selection are some of the components of the QMS which are designed to manage and mitigate risk.

 

Full suite of Standard Operating Procedure for Quality, Clinical,  Data Management, Statistics. Pharamcovigilance  and all  clinical research activities carried out by CRF-C.

Number

Title

Version

Effective Date

Quality Manual   (1,847kB)3.001-Sep-17
Quality Policy Statement   (105kB)2.001-Aug-17