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Forms & Resources

​Forms

Document Name ​Version Number & Date ​Link
CIRB Application / Amendment Form and Exemption Application/ Amendment Form Template (mandatory field and info) (For Reference Only) ​v8, 4 Apr 2023Download
​Changes to External Study Team Members Form​v3, 17 Mar 2021Download
Type of Study Determination Form​v5, 19 Sep 2022Download
​Restricted Human Biomedical Research Form​v1, 27 Sep 2022Download
​Non-Local SAE Reporting Form ​v0, 24 Jun 2020Download


Templates

Document Name ​Version Number & Date ​Link
​Amendment Summary​v1, 30 Aug 2013Download
​Certification of Translation​v2, 14 Jan 2015Download

​Child/Participant Assent Form

- Summary of Changes: Child/Participant Assent Form (version 3 to 4)

​v4, 10 Aug 2022Download

​Protocol (Clinical Trial)

- Summary of Changes: Clinical Trial Protocol (version 6 to 7)

​v7, 7 Jun 2021

Download

​Protocol (Research Study)

- Summary of Changes: Research Study Protocol (version 6 to 7)

​v7, 7 Jun 2021

​Download

​Participant Information Sheet & Informed Consent Form
- Summary of Changes: Participant Information Sheet & Consent Form (version 12.4 to 13)
​v13, 23 Feb 2023Download
​Guidance on Requirements For Informed Consent Documents​v3, 23 Feb 2023​Download
​Waiver of CITI Certification Form ​v2, 11 May 2018 Download


Checklists

Document Name ​Version Number & Date ​Link

​Appropriate Consent Checklist for HBR study

​v3, 16 Jul 2022Download
Core and Situational Consent Elements Checklist for HBR study ​v1, 16 Jul 2022 ​Download
​Consent Checklist for Clinical Trials​v0, 16 Jul 2022Download
Initial Application Checklist ​v1, 27 Sep 2022Download


Guidelines

Document Name ​Version Number & Date ​Link
​Advertisements for Recruitment of Research Participants ​v2, 29 Mar 2022Download
Centralised Institutional Review Board (CIRB) Researcher Handbook

v1.1, 14 Mar 2022

​Download
​Reporting Requirement and Timeline for SAE v1, 19 May 2020Download
​Use of Thumb-print on Informed Consent Form ​v2, 29 Mar 2022Download
​Waiver of Consent for Research Regulated by HBRA ​v4, 23 Apr 2020 Download


iSHaRe User Guide

Document Name ​Version Number & Date ​Link
​New Application Submission​v8, 11 Jun 2015 ​Download
​Department and Institution Representative Endorsement​v6, 22 Dec 2016 ​Download
​Study Renewal Submission​v3, 2 Jul 2015Download
CIRB Comment ​v1, 13 Jun 2016 ​Download


Others

Document NameVersion Number & DateLink
​Glossary of Lay Terms for Use in Consent Documents​v1, 26 Jul 2016Download
FAQ: Duke-NUS & SingHealth Collaborative Research Ethics Reviewv4, 20 Feb 2023 Download