As per other SingHealth institutions, please submit the entire IRB submission dossier for ethics review. This dossier should include the following i.e.

• IRB/ DSRB application form and relevant Annexes (if applicable)
• Study protocol
• Patient Info Sheet & Informed Consent Form (if applicable)
• Other trial-related documents (if any)

All industry-sponsored studies are required to pay the IRB review fees as well as administrative charges amounting to $2,625 for each sponsored studies.

Please be informed that the SNEC IRB approval process involves both scientific and ethical deliberations, hence kindly allow us a time-frame of around 6 to 8 weeks for the entire IRB review process. Nevertheless, rest assured that we will endeavor to process every application in a timely fashion.

Applicants are required to complete the main IRB/ DSRB application form and relevant Annexes (if any), and forward together with the study protocol, consent document and other trial-related documents (if any) to the SERI IRB Secretariat at the following address:

Please submit the original signed copy, 13 hardcopies as well as a soft-copy of the above-mentioned documents to us.

Additionally, for industry-sponsored studies, to note that the Clinical Trial Agreement and the Study budget have to be discussed and finalized prior to study commencement. However, this can be done concurrently with the IRB approval process.

Further to this, w ith effect from 1st May 2005, SingHealth stipulates that ALL investigators (PI and co-Investigators) submitting protocols to SingHealth cluster-wide IRBs for approvals and renewals, will be required to attach a Certificate of Completion of the CITI Course (Collaborative IRB Training Initiative) for each and every investigator listed.

Submissions without the certificates for ALL listedinvestigators will automatically be rejected.

The CITI course is available on-line through the SHS Research Internet at http://www.singhealth.com.sg/singhealth_research/