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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 2023	Download
Changes to External Study Team Members Form	v3, 17 Mar 2021	Download
Type of Study Determination Form	v5, 19 Sep 2022	Download
Restricted Human Biomedical Research Form	v1, 27 Sep 2022	Download
Non-Local SAE Reporting Form	v0, 24 Jun 2020	Download

Templates

Document Name	Version Number & Date	Link
Amendment Summary	v1, 30 Aug 2013	Download
Certification of Translation	v2, 14 Jan 2015	Download
Child/Participant Assent Form - Summary of Changes: Child/Participant Assent Form (version 3 to 4)	v4, 10 Aug 2022	Download
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 2023	Download
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 2022	Download
Core and Situational Consent Elements Checklist for HBR study	v1, 16 Jul 2022	Download
Consent Checklist for Clinical Trials	v0, 16 Jul 2022	Download
Initial Application Checklist	v1, 27 Sep 2022	Download

Guidelines

Document Name	Version Number & Date	Link
Advertisements for Recruitment of Research Participants	v2, 29 Mar 2022	Download
Centralised Institutional Review Board (CIRB) Researcher Handbook	v1.1, 14 Mar 2022	Download
Reporting Requirement and Timeline for SAE	v1, 19 May 2020	Download
Use of Thumb-print on Informed Consent Form	v2, 29 Mar 2022	Download
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 2015	Download
CIRB Comment	v1, 13 Jun 2016	Download

Others

Document Name	Version Number & Date	Link
Glossary of Lay Terms for Use in Consent Documents	v1, 26 Jul 2016	Download
FAQ: Duke-NUS & SingHealth Collaborative Research Ethics Review	v4, 20 Feb 2023	Download