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Quality Management System

Overview

Research Quality Management System (RQMS) is developed to provide compliance oversight and promotes research integrity for research activities, which are subject to the Human Biomedical Research Act (HBRA) and Clinical Trial regulations conducted within the SingHealth Group.

Objectives:
• To ensure qualified and appropriately trained resources, effective controls and management oversight;
• To provide quality management consistent with regulatory requirements and international standards;
• To be inspection ready at all times by regulatory agencies;
• To ensure continuous improvement

Consistent with SingHealth core values and culture, quality is a shared responsibility across the research community for research involving research subjects. The stakeholders refer to internal SingHealth and affiliated institutions, researcher, research administrators and Centralised Institutional Review Board (CIRB).


Quality Management Analytics


Quality metrics and quality indicators are being developed to measure compliance, quality and for taking early actions to improve deficiencies.

The quality metrics are developed from (i) monitors performing monitoring visits; and (ii) researchers self-reporting via iSHaRe.

The commonly found quality issues are related to informed consent process, failure to follow the protocol, failure to keep adequate and accurate records, failure to report serious adverse events and failure to account for disposition of study drugs.

Categories of Quality Issues ​ ​
Subject RecruitmentInformed ConsentData Management
Protocol Deviation & Non-ComplianceSerious Adverse Events (SAEs) & Safety ReportingInvestigational Product (IP) & Medical Devices Management
Randomisation / Blinding & UnblindingClinical Supplies & FacilitiesSite Qualifications & Responsibilities
Investigator Site FilesHuman Biological MaterialOther Findings


 

Quality Issues Identification and Management Process


Quality of clinical research conduct and data integrity are of utmost priority in SingHealth. In order to achieve an effective and proactive quality management, a risk-based approach is adopted for quality management to define priorities and take appropriate actions to achieve quality objectives.

The team within RICE works with the institutions stakeholders to achieve:
  • Compliance with applicable laws, regulations and SingHealth policies and standards
  • Conduct oversight activities to minimise adverse regulatory enforcement action
  • Maintain, enhance and support effective quality and compliance systems designed to timely detect, correct and prevent activities deviating from applicable laws, regulations and/or SingHealth policies


 For more information, refer to SingHealth Quality Standards for Conduct of Clinical Research (Doc. No. SHS-RSH-ORIC-CWP-208) (Intranet Only)