Translating Research into Highest Quality Patient Care

Ethics Forms and Templates


Mandatory Reports to DSRB

 

Document No.

Form

Effective Version

205-010

Study Amendment Cover Note

Ver 4, dated 1 Jun 09

205-011

Study Status Report Form 

Ver 7, dated 20 Nov 09

205-016

Non-Compliance / Protocol Deviation Report Form 

Ver 2, dated 1 Jun 09

205-012

UPIRTSO Report Form

Ver 6, dated 1 Apr 22

205-030

Expected Serious Adverse Event (SAE) Reporting Form & Guide 

Ver 1.2, dated 22 Mar 18

 

Application Forms

 

Document No.

Form

Effective Version

205-002

Annex A - Placebo use  

Ver 2.0, dated 19 Jan 07

205-003

Annex B - Conflict of Interest Declaration

Ver 9.1, dated 01 July 22

205-004

Annex C - Biological Materials Storage  

Ver 2.0, dated 19 Jan 07

205-005

Annex D - Industry Sponsored Studies  

Ver 2.0, dated 19 Jan 07

205-006

Annex E - Waiver of Informed Consent  

Ver 2.0, dated 19 Jan 07

205-007

Annex F - Research involving Pregnant Women, Foetuses & Neonates 

Ver 2.0, dated 19 Jan 07

205-008

Annex G - Research involving Children (For persons less than 21 years old)  

Ver 2.0, dated 19 Jan 07

205-009

Annex H - Research involving Prisoners  

Ver 2.0, dated 19 Jan 07

205-015

Waiver of CITI Certification Form (for waiver of PI's minimum training requirements) 

Ver 1.0, dated 1 Aug 06

205-029

DSRB Waiver of Completion of SGGCP Certification Form 

Ver 2.0, dated 19 Jun 14

205-031

Study Team Member List for FCOI Declaration

Ver 4.0, dated 27 Nov 19

205-037 Notice of Intent Application Form Ver 1.0, dated 30 Mar 12

E01

Study Team Members list 

Ver 1.0, dated 19 Jan 07

E02

Principal Investigator's Declaration 

Ver 1.0, dated 19 Jan 07

E03

Study Team Members' endorsement  

Ver 1.0, dated 19 Jan 07

205-021

Departmental Representative endorsement

Ver 2.0, dated 30 Mar 22

205-022

Institutional Representative endorsement 

Ver 3.0, dated 30 Mar 22

205-035 HoD and CMB Endorsement Ver 1.0, dated 30 Mar 22

E06

Characteristics of Target Study Participants 

Ver 1.0, dated 19 Jan 07

 

NHG Standing Database Registry

 

Document No.

Form

Effective Version

205-020

NHG Registration of Standing Database and Tissue Bank Form 

Ver 1.0, dated 1 Jun 09

 

DSRB Templates for Study Documentation

 

The following templates are provided as a guide for PI's to create their own study documents. These templates contain the critical elements which are required by the DSRB. While it is not compulsory to use these templates, PI's are encouraged to do so.

 

Document No.

Form

Effective Version

207-001

(a) Informed Consent Form Template   

(b) Summary of Changes for ICF Template   

Ver 13, dated 31 Jan 22

1704-15

Optional Consent Form for the Donation of Leftover Biological Samples 

Ver 2.0, dated 26 Nov 21

1704-16

Optional Consent Form for the Donation of Leftover Biological Samples with English Short Consent Form Template for non-english speaking subject 

Ver 2.0, dated 26 Nov 21

1704-17

Optional Consent Form for the Donation of Leftover Biological Samples with Simplified Chinese Short Consent Form Template for non-english speaking subject 

Ver 2.0, dated 26 Nov 21

1704-18

Optional Consent Form for the Donation of Leftover Biological Samples with Malay Short Consent Form Template for non-english speaking subject 

Ver 2.0, dated 26 Nov 21

1704-19

Optional Consent Form for the Donation of Leftover Biological Samples with Tamil Short Consent Form Template for non-english speaking subject 

Ver 2.0, dated 26 Nov 21

207-002

Study Protocol Template

Ver 3, dated 1 Jun 09

207-003

Sample language for documentation of Capacity 

Ver 1, dated 1 Aug 06

207-004

ICF with Original English Short Consent Form Template for non-english speaking subject

Ver 10, dated 30 Nov 18

207-005

ICF with Simplified Chinese language Short Consent Form Template for non-english speaking subjects 

Ver 10, dated 30 Nov 18

207-006

ICF with Malay language Short Consent Form Template for non-english speaking subjects  

Ver 10, dated 30 Nov 18

207-007

ICF with Tamil language Short Consent Form Template for non-english speaking subjects

Ver 10, dated 30 Nov 18

207-008

Assent Form Template 

Summary of Updates to DSRB Assent Form Template 

Ver 2, dated 14 Feb 22

207-009

Certification of Translation

Ver 1, dated 13 Aug 12

 

NUHS PDPA Declaration Form for Waiver of Consent

 

The following template is provided for NUHS Department and Institution Representatives.

 

 Document No.

Form

Effective Version

N.A

NUHS PDPA Declaration Form for Waiver of Consent

Ver 1.2, dated 21 Apr 21