December 2013 What Is The Difference Between NHG RQM Study Reviews & HSA Inspections? (Part 1) During the conduct of a trial, the Principal Investigator (PI) may have received a “Notice of Good Clinical Practice (GCP) Site Inspection” from the Health Sciences Authority (HSA) or a notification from the National Healthcare Group (NHG) Research Quality Management (RQM) for a Study Review (Audits). So what is the difference between the two? Definition of inspection and audit: Inspection: The act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at the site of the trial, sponsor’s and/or contract research organisation’s (CRO) facilities, or at other establishments deemed appropriate by the regulatory authority. (SGGCP Sec 1.29). Here the regulatory body refers to the Health Science Authority (HSA). Audit: A Systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted and the data were recorded, analysed and accurately reported according to the protocol, sponsor’s standard operating procedure (SOP), Good Clinical Practice (GCP) and applicable regulatory requirement (SGGCP Sec 1.6). HSA GCP Site Inspection NHG RQM Study Review (Audits) Scope of GCP Inspection Applies to clinical trials on medicinal products, with a Clinical Trial Certificate (CTC) being conducted in Singapore (i.e. site, phase-I/Clinical Research Units, Sponsors and CRO). Scope of RQM Study Review Audits Applies to all research reviewed and approved by the NHG DSRB. This will include all research conducted by or under the direction of any employee of NHG and all research conducted using property or facility of NHG (i.e. Investigator Initiate Trials). Types of Inspection/ Audits • Routine (Random selection from database) • Triggered (For Cause) • (HSA only) Pre-marketing approval application inspections Objectives of HSA GCP Inspection & NHG RQM Study Review Audits i. Safeguard the rights, safety and well-being of trial subjects. ii. Verify the quality and integrity of the clinical trial data submitted to the Regulatory Authorities. iii. Assess compliance to the protocol, applicable regulations, guidelines and standard operating procedures for clinical trials. iv. Promote a research culture that operates on high ethical standards. v. Promote responsible conduct of research within the research community. References http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials/guidelines/gcp_compliance_inspection .html Singapore Good Guideline for Good Clinical Practice (SGGCP) 1.6: Glossary - Audit Singapore Good Guideline for Good Clinical Practice (SGGCP) 1.29: Glossary – Inspection NHG Investigator Manual (2nd Edition): Chapter 9.0 – Preparing for Audits https://www.research.nhg.com.sg/wps/wcm/connect/romp/nhgromp/hspp/rqframework/study+reviews+audits Article Contributed By: Ms Xu Xiaoying, Research Nurse Supervisor, Johns Hopkins Singapore International Medical Center Edited By: NHG-RDO Proudly brought to you by: Clinical Research Coordinator Society (CRCS) [email protected]