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

  • 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 (ICH GCP) 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.

 

QMS

Figure 1: HRB-CRF-C QMS components

 

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.

Number Title Version Effective Date
  Quality Policy Statement (105kB) 1.0 1-Aug-14
Number Title Version Effective Date
  Quality Manual (1,847kB) 2.0 1-Jun-15 

Quality SOP's

Number Title Version Effective Date
 QTY-1  Preparation, Review and Approval of CRF-C SOPs 2.0 30-Sep-15
 QTY-2  Staff Induction and Training 2.0 30-Sep-15
 QTY-3  Setting up and Maintaining Investigator Site File/Sponsor TMF 2.0 30-Sep-15
 QTY-4  Investigator Responsibilities 2.0 30-Sep-15
 QTY-5  Ethics Approval Process 2.0 30-Sep-15
 QTY-6  Change Control 2.0 30-Sep-15
 QTY-7  Internal and External Audit and Quality Reviews 2.0 30-Sep-15
 QTY-8  Safety Reporting 2.0 30-Sep-15
 QTY-9  Non Conformance 2.0 30-Sep-15
 QTY-10  Study Monitoring at CRF-C 2.0 30-Sep-15
 QTY-11  Selection and Management of Third Party Vendors and Suppliers 2.0 30-Sep-15
 QTY-12  Hosting a Regulatory Inspection 2.0 30-Sep-15
 QTY-13  Document Control and Archiving 2.0 30-Sep-15
 QTY-14  Equipment logging, servicing and calibration 2.0 30-Sep-15
 QTY-15  Regulatory Authority Approval and Communication 2.0 30-Sep-15
 QTY-16  Clinical and IMP Green light procedure 2.0 30-Sep-15
 QTY-17  Use of the CRF-C Pharmacy Storage Facility 2.0 30-Sep-15
 QTY-18  Granting Approval for using CRF-C Facilities and Resources 2.0 30-Sep-15
 QTY-19 Business Continuity 2.0 30-Sep-15

 

Pharmacovigilance SOP's

Number Title Version Effective Date
PV-1 Receipt and Processing of Safety Data for UCC sponsored Clinical Trials and Clinical Investigations 4.0 31-Jan-2017
PV-2 Preparation and Submission of the development Safety Update Report for UCC Sponsored Clinical Trials 2.0 31-Jan-2017
PV-3 Ongoing Risk Benefit Analysis for UCC Sponsored HPRA studies 2.0 31-Jan-2017
PV-4 SUSAR processing and reporting for UCC sponsored studies 1.0 31-Jan-2017
PV-5 Management of Reference Safety Information for UCC sponsored Clinical Trials 1.0 16-Mar-2017
PV-6 Pregnancy and Overdose 1.0 16-Mar-2017
PV-7 SAE reconciliation for UCC sponsored Clinical Trials 1.0 16-Mar-2017

Data Management SOP's

Number Title Version Effective Date
DM-1 Data Management 1.0 31-Jan-2015
DM-2

Framework Standard Operating Procedure:Computer System 

Validation for Clinical Trials 

1.0 31-Jan-2015
DM-3 Cloud Computing Vendor Checklist 1.0 31-Jan-2015
DM-4 IT Vendor Checkilist 1.0 31-Jan-2015
DM-5 21 CRF 11 Checklist 1.0 31-Jan-2015

Clinical SOP's

Number Title Version Effective Date
CLN-1 Obtaining Informed Consent 3.0 30-Sep-2015
CLN-2 Phlebotomy 2.0 20-May-2015
CLN-3 Handling Dry Ice 2.0 20-May-2015
CLN-4 Biological Sample Management 2.0 20-May-2015
CLN-5 Using and Measuring a Visual Analogue Scale 2.0 20-May-2015
CLN-6 Urinary Pregnancy Testing 2.0 20-May-2015
CLN-7 Measuring of Waist to Hip Ratio 2.0 20-May-2015
CLN-8 Dealing with Hypotension or Syncope 2.0 20-May-2015
CLN-9 Temperature Monitoring 3.0 07-Dec-2015
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