Translating Research into Highest Quality Patient Care

Proper Conduct of Research SOPs & Templates


  

    The following documents can only be accessed when you have direct access to the NHG Intranet at the time of downloading.

These documents are strictly for internal circulation among NHG Staff members and Authorized personnel only.

 

 

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 link 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 familiarise yourselves with the new requirements.

 

 

Summary of Updates to Proper Conduct of Research SOPs

 

The summary of the recent updates to PCR SOPs can be downloaded here.

Summary of Changes to PCR SOP (Last updated: 04-Feb-22)

 

PCR SOP

 

501-A01: Preparing, Minimum and Communicating PCR SOPs (Effective 01-Nov-2016)

501-A02: Responsibilities of the Research Team (Effective 12-Nov-2021)

501-A03: Training and Education (Effective 28-Jan-2022)

501-B01: Assessing Protocol Feasibility (Effective 31-Jan-2019)

501-B02: Pre-study Activities (Effective 12-Nov-2021)

501-B03: Study Initiation (Effective 31-Jan-2019)

501-B04: Interactions with DSRB (Effective 30-Apr-2020)

501-B05: Documentation (Effective 12-Nov-2021)

501-B06: Investigational Product Accountability (Effective 12-Nov-2021)

501-B07: Study Conduct - Monitoring (Effective 12-Nov-2021)

501-B08: Data Collection and Handling (Effective 22-Oct-2020)

501-B09: Study Completion Activities (Effective 31-Jan-2019)

501-B10: Handling Audits/ Inspections (Effective 12-Nov-2021)

501-C01: Informed Consent Form and Process (Effective 01-Mar-2022)

501-C02: Subject Screening and Recruitment (Effective 07-Apr-2021)

501-C03: Subject Management During Study (Effective 31-Aug-2019)

501-C04: Biological Specimen Collection and Handling (Effective 30-Apr-2020)

501-C05: Unanticipated Problems Involving Risks to Subjects or Others and Expected Serious Adverse Event (Effective 01-Nov-2017)

 

 

CHECKLIST

504-002: Feasibility Assessment Checklist (Effective 17-Jan-2019)

504-004: Study Closure Checklist (Effective 04-Aug-2021)

504-005: Pre-Audit Checklist (Effective 04-Mar-2020)

504-006: RQM Study Review Checklist (Effective 21-Oct-2014)

504-007: NHG RQM PISAF (Effective 30-Oct-2019)

504-008: Eligibility Checklist (Effective 17-Jan-2019)

 

FORMS

505-001: Training Record Form (Effective 11-Nov-2016)

 

 

TEMPLATES

507-002: Investigator File Contents Template (Effective 08-Oct-2020)

507-003: Investigator File Dividers (Effective 23-Oct-2018)

507-005: Corrective Action and Preventive Action Plan (Effective 05-Mar-2020)

507-006: Note-To-File Template (Effective 13-May-2013)

507-007: Template for Documentation of Adverse Event (Effective 13-May-2013)

507-008: Monitoring Plan template (Effective 03-Dec-2013)

 

 

LOGS

509-001: SOP Communication Log (Effective 01-Jun-2006)

509-002: Study Responsibility / Delegation Log (Effective 05-Mar-2020)

509-003: Non-compliance / Protocol Deviation Tracking Log (Effective 05-Mar-2020)

509-004: Device Accountability Log (Effective 27-Dec-2018)

509-005: Investigational Product Inventory Log (Effective 14-May-2013)

509-006: Site Monitoring Log (Effective 14-May-2013)

509-007: Subject Screening and Enrollment Log (Effective 04-Mar-2020)

509-008: Subject Visit Schedule Log (Effective 05-Mar-2020)

509-009: Biological Specimen Log (Effective 04-Mar-2020)

509-010: UPIRTSO Tracking Log (Effective 25-May-2016)

509-011: Adverse Event /  Serious Adverse Event Tracking Log (Effective 05-Mar-2020)

509-012: Investigational Product Dispensing & Accountability Log  (Multiple Subjects) (Effective 27-Dec-2018)

509-013: Investigational Product Dispensing & Accountability Log (Per Subject) (Effective 27-Dec-2018)

509-014: Subject Identification Log (Effective 04-Mar-2020)

509-015: Temperature Log (Effective 15-May-2013)

509-016: Study Initiation Meeting Attendance Log (Effective 15-May-2013)

509-017: ICF Tracking Log (Effective 20-May-2020) 

509-018 Study Document Translation Tracking Log (Effective 08-Oct-2020)

 

GUIDANCE

599-002: Categorisation of Deficiencies Identified (Effective 29-Dec-2021)

599-005: Guidance Document on Electronic Informed Consent Process (Effective 08-Jun-2021)

599-006: Guidance Document on Electronic Filing of Essential Documents (Effective 01-Apr-2020)

 

 

    The documents above can only be accessed when you have direct access to the NHG Intranet at the time of downloading.

These documents are strictly for internal circulation among NHG Staff members and Authorized personnel only.