Population Health Research Institute
Central Support

Quality Assurance and Education

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Quality Assurance

The Quality Assurance Department provides support to all departments at PHRI to achieve quality research. The Quality Assurance Program is comprised of three main components, those being the management of Standard Operating Procedures, an Audit Program and Continuous Quality Improvement.

Standard Operating Procedures

The Quality Assurance department provides direction in the creation and development of more than 100 Policies and Standard Operating Procedures for all functional areas at PHRI and centrally manages their distribution and control. This includes defining the structure and format requirements, the authorization and control, and content development of all PHRI Policies and Standard Operating Procedures.

For an up-to-date listing of our current Standard Operating Procedures, please contact the Quality Assurance Coordinator (PHRI.QA@phri.ca).

Audits

The internal audit function performed by the QA department is required to provide the independent review of specific operational areas to review compliance of regulatory requirements. The audit program includes internal audits of all PHRI operations, vendor audits where regulated activities are involved and National Leaders and Investigator Sites where PHRI has responsibility for their compliance to regulatory requirements.

In addition, the QA department hosts external parties (sponsors or regulatory agencies) when they conduct audits of PHRI. PHRI hosts approximately 8 - 10 audits from pharmaceutical global compliance auditors annually.

Continuous Improvement

The main focus of this component is to review trends to identify systemic root causes and improvements. Identification of systemic issues will allow for organization wide process improvements and may also assess the effectiveness of the Corrective and Preventive Actions (CAPA) implemented for the individual incident. In some instances, the incidents will occur outside PHRI – but impacting PHRI operations and will require collaboration with the study sponsors and National Leaders as well

Education and Training

The mandate for Education and Training is for the development of a sustainable education/training program at PHRI that provides a comprehensive catalogue of training opportunities to meet the needs of all the positions at PHRI. The program consists of five main streams: Computer Systems training, Developmental training, Organizational training, Procedural training and Regulatory training. We use a variety of methods and tools in delivering the education and training. This includes classroom, online and blended learning supported by an electronic Learning Management System which serves more than 280 staff and associates and potentially will provide training remotely to investigator sites around the world. Examples of some of the topics currently provided to staff include:

Computer Systems Training

  • Microsoft Office 2010

Developmental Training

  • General Considerations for Clinical Trials
  • Management training
  • Project Management concepts

Organizational Training

  • Accessible Customer Service (AODA)
  • Fire Safety
  • Office WHMIS
  • Violence Prevention

Procedural Training

  • Standard Operating Procedures
  • Computer Applications (Datafax, MedDRA, SAS, etc)
  • Data Management Practices

Regulatory Training

  • Good Clinical Practice (ICH E6, FDA 21 CFR 50, 54, 56, 312)
  • FDA 21 CFR Part 11 (Computerized Systems - Electronic Records and Signatures
  • Privacy (HIPPA, PIPPEDA,FIPPA)
  • ISO 14155 - Medical Device Standards

     

       

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Population Health Research Institute • Hamilton, Ontario • information@phri.ca