NHG Proper Conduct of Research SOPs & Templates
NHG Proper Conduct of Research
Standard Operating Procedures and Templates
These are a set of guidelines and templates developed by NHG 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
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Download the Summary of Changes to PCR SOP here (Last updated: 21-Mar-24)
PCR SOPs & Templates
These documents are strictly for internal circulation among NHG Staff and Authorized personnel only.
* Access to these files is Restricted (NHG Intranet access required).
Standard Operating Procedures (SOPs)
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501-A01: Preparing, Minimum and Communicating PCR SOPs (Effective 01 Nov 2016)
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501-A02: Responsibilities of the Research Team (Effective 12-Nov-2021)
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501-B01: Assessing Protocol Feasibility (Effective 31-Jan-2019)
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501-B06: Investigational Product Accountability (Effective 12-Nov-2021)
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501-B08: Data Collection and Handling (Effective 10-Nov-2023)
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501-B09: Study Completion Activities (Effective 31-Jan-2019)
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501-B10: Handling Audits/ Inspections (Effective 12-Nov-2021)
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501-C01: Informed Consent Form and Process (Effective 31-Jul-2023)
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501-C02: Subject Screening and Recruitment (Effective 07-Apr-2021)
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501-C03: Subject Management During Study (Effective 31-Aug-2019)
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501-C04: Biological Specimen Collection and Handling (Effective 30 Apr 2020)
Logs
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509-002: Study Responsibility / Delegation Log (Effective 05-Mar-2020)
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509-003: Non-compliance / Protocol Deviation Tracking Log (Effective 05-Mar-2020)
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509-005: Investigational Product Inventory Log (Effective 14-May-2013)
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509-007: Subject Screening and Enrollment Log (Effective 04-Mar-2020)
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509-011: Adverse Event / Serious Adverse Event Tracking Log (Effective 05-Mar-2020)
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509-016: Study Initiation Meeting Attendance Log (Effective 15-May-2013)
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509-018 Study Document Translation Tracking Log (Effective 08-Oct-2020)