Quality Management System | SingHealth Duke-NUS

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

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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 Recruitment	Informed Consent	Data Management
Protocol Deviation & Non-Compliance	Serious Adverse Events (SAEs) & Safety Reporting	Investigational Product (IP) & Medical Devices Management
Randomisation / Blinding & Unblinding	Clinical Supplies & Facilities	Site Qualifications & Responsibilities
Investigator Site Files	Human Biological Material	Other 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)