NHG Health Proper Conduct of Research SOPs & Templates
These are a set of guidelines and templates developed by NHG Health Group Research to provide detailed procedures on conducting research in accordance with applicable guidelines and regulations. You may adapt and modify these templates to suit your individual research needs
NHG Health Proper Conduct of Research Standard Operating Procedures and Templates
These are a set of guidelines and templates developed by NHG Health Group Research to provide detailed procedures on conducting research in accordance with applicable guidelines and regulations. You may adapt and modify these templates to suit your individual research needs.
For Clinical Trials Regulated Under the Health Products Act and Medicines Act
Please note that the revised regulatory requirements should be complied with from 1st Nov 2016. You may refer to this page here for more details on the revised requirements.
For Human Biomedical Research Regulated Under the Human Biomedical Research Act (HBRA)
Please note that the PCR SOPs have been updated in alignment with the HBRA. Please familiarize yourselves with the new requirements.
Summary of Updates
PCR SOPs & Templates
These documents are strictly for internal circulation among NHG Health Staff and Authorized personnel only.
* Access to these files is Restricted (NHG Health Intranet access required).
Standard Operating Procedures (SOPs)
501-A01: Preparing, Minimum and Communicating PCR SOPs (Effective 01-Dec-2025) (opens in new tab)
501-A02: Responsibilities of the Research Team (Effective 01-Sept-2025) (opens in new tab)
501-A03: Training and Education (Effective 01-Sept-2025) (opens in new tab)
501-B01: Assessing Protocol Feasibility (Effective 01-Dec-2025) (opens in new tab)
501-B02: Pre-study Activities (Effective 01-Dec-2025) (opens in new tab)
501-B03: Study Initiation (Effective 01-Sept-2025) (opens in new tab)
501-B04: Interactions with DSRB (Effective 01-Sept-2025) (opens in new tab)
501-B05: Documentation (Effective 01-Dec-2025) (opens in new tab)
501-B06: Investigational Product Accountability (Effective 01-Dec-2025) (opens in new tab)
501-B07: Study Conduct - Monitoring (Effective 01-Dec-2025) (opens in new tab)
501-B08: Data Collection and Handling (Effective 02-Jun-2026) (opens in new tab)
501-B09: Study Completion Activities (Effective 01-Dec-2025) (opens in new tab)
501-B10: Handling Audits/ Inspections (Effective 01-Dec-2025) (opens in new tab)
501-C01: Informed Consent Form and Process (Effective 01-Sept-2025) (opens in new tab)
501-C02: Subject Screening and Recruitment (Effective 01-Sept-2025) (opens in new tab)
501-C03: Subject Management During Study (Effective 01-Sept-2025) (opens in new tab)
501-C04: Biological Specimen Collection and Handling (Effective 01-Dec-2025) (opens in new tab)
Checklist
504-002: Feasibility Assessment Checklist (Effective 17-Jan-2019) (opens in new tab)
504-004: Study Closure Checklist (Effective 04-Aug-2021) (opens in new tab)
504-005: Pre-Audit Checklist (Effective 04-Mar-2020) (opens in new tab)
504-007: NHG RQM PISAF (Effective 4-Feb-2026) (opens in new tab)
504-008: Eligibility Checklist (Effective 17-Jan-2019) (opens in new tab)
Forms
Templates
507-002: Investigator File Contents Template (Effective 08-Oct-2020) (opens in new tab)
507-003: Investigator File Dividers (Effective 23-Oct-2018) (opens in new tab)
507-005: Corrective Action and Preventive Action Plan (Effective 23-Dec-2024) (opens in new tab)
507-006: Note-To-File Template (Effective 13-May-2013) (opens in new tab)
507-007: Template for Documentation of Adverse Event (Effective 13-May-2013) (opens in new tab)
507-008: Monitoring Plan template (Effective 03-Dec-2013) (opens in new tab)
Logs
509-001: SOP Communication Log (Effective 01-Jun-2006) (opens in new tab)
509-002: Study Responsibility / Delegation Log (Effective 05-Mar-2020) (opens in new tab)
509-003: Non-compliance / Protocol Deviation Tracking Log (Effective 05-Mar-2020) (opens in new tab)
509-004: Device Accountability Log (Effective 27-Dec-2018) (opens in new tab)
509-005: Investigational Product Inventory Log (Effective 14-May-2013) (opens in new tab)
509-006: Site Monitoring Log (Effective 14-May-2013) (opens in new tab)
509-007: Subject Screening and Enrollment Log (Effective 04-Mar-2020) (opens in new tab)
509-008: Subject Visit Schedule Log (Effective 05-Mar-2020) (opens in new tab)
509-009: Biological Specimen Log (Effective 04-Mar-2020) (opens in new tab)
509-010: UPIRTSO Tracking Log (Effective 25-May-2016) (opens in new tab)
509-014: Subject Identification Log (Effective 04-Mar-2020) (opens in new tab)
509-015: Temperature Log (Effective 15-May-2013) (opens in new tab)
509-016: Study Initiation Meeting Attendance Log (Effective 15-May-2013) (opens in new tab)
509-017: ICF Tracking Log (Effective 20-May-2020) (opens in new tab)
509-018 Study Document Translation Tracking Log (Effective 08-Oct-2020) (opens in new tab)
Guidance
Pocket Guides
These pocket guides provide quick reference for research conduct within NHG Health, derived from NHG Health PCR SOPs. They offer NHG Health-specific guidance and should be used alongside official guidelines, regulations and institutional policies.
