30 Mar 2010 ~ NEW MINIMUM REQUIREMENT FOR PI - SG GCP
With effect from 1 April 2010, the minimum training for Principal Investigators (PIs) conducting
clinical trials within SingHealth will include completing the Singapore Guidelines for Good
Clinical Practice Program Course (in addition to the current requirement for CITI) when making
a submission to the CIRB.  However, a grace period of 3 years will be granted for PIs to obtain
this requirement.  Thus, CIRB will continue to accept and review applications from PIs that have
yet to complete the SGGCP course till 31 March 2013.  But by 1 April 2013, CIRB will not grant ethics
approval for clinical trials applications until receipt of PI's proof of completing the SGGCP course.

12 Jan 2010 ~ CITI CERTIFICATION
With effect from 1 January 2010, renewal of the CITI certification is not required for CIRB application.
___________________________________________________________________________

CIRB FORMS

Initial Submission/ Application:

Instruction Sheet

CIRB Application Form Instruction Sheet *Updated as of 2 Feb 12*

Application Form

CIRB & DSRB Application Form *Updated as of 27 Mar 12*

Annex

1) Annex A - Placebo use
2) Annex B - COI Declaration Form
3) Annex C - Biological Materials Storage
4) Annex D - Industry Sponsored Studies
5) Annex E - Waiver of Informed Consent
6) Annex F - Research involving Pregnant Women, Foetuses and Neonates
7) Annex G - Research involving Children
8) Annex H - Research involving Prisoners

Extra Page

1) Study Team members extra page
2) PI's Declaration extra page
3) Study Team members' endorsements extra page
4) HOD's Endorsement extra page
5) IR's Endorsement extra page
6) Characteristics of Target Study Participants extra section 

Renewal/Closure:

             CIRB Study Status Report Form *Updated as of 27 Mar 12*

Reporting to CIRB:

             CIRB SAE Reporting Form 

Templates/ Others:

             1) Participant Information Sheet and Informed Consent Template *Updated as of 15 Mar 12*
             2) Assent Form Template
             3) SGH Study Drug Form (Only for SGH Drug Trial)

GENERAL INFORMATION

            1) Timelines and Procedure for Reporting SAE-AE *Updated as of 9 May 12*
            2) List of Institution Representatives *Updated as of 2 Feb 12*
            3) The Five Review Boards of CIRB
            4) 2012 CIRB Meeting Dates *Updated as of 24 Apr 12*
            5) Data Security Guidelines for Personally Identifiable and other Confidential Data in Research - Electronic Data  NEW