Overview

Institutional Review Board (IRB)

Research Programmes

	WHO SHOULD SUBMIT APPLICATIONS TO THE IRB
	REQUIREMENTS FOR IRB APPLICATION TO CONDUCT RESEARCH STUDIES
	CONTACT US

1. Investigator-initiated Clinical Trials only: For new study applications as well as protocol amendments, please submit 1 original hardcopy + 9 duplicate hardcopies + an email softcopy (of all documents including cover letter) to Lee.Y.H@nccs.com.sg. 2. For industry sponsored studies only: With effect from 1 Jan 2008, the IRB will impose a review fee of S$100 + prevailing GST for subsequent protocol amendments. 3. To access online CITI and GCP course: http://www.citiprogram.org/

1. Data through intervention or interaction with the individual or
2. Identifiable private information, including biological samples

1. Drug / devices / other clinical trials
2. Questionnaires / Surveys
3. Retrospective (records-based) Studies
4. Studies involving the use of biological samples (including cell lines)

For more enquiries on whether your study requires IRB approval, please contact the IRB Secretariat.

REQUIREMENTS FOR IRB APPLICATION TO CONDUCT RESEARCH STUDIES

Under the new SingHealth Institutional Review Board Standard Operating Procedures (IRB SOP) adopted on 10 Nov 2006, the following have been implemented in NCC:

• All studies will be granted up to 1-year approvals each time.
• For clinical trials, guidelines for safety reporting (Serious Adverse Events / Adverse Events) have been revised with immediate effect. Kindly see appendage below for more information.
  [Timelines and Procedures for Safety Reporting]
• With effect from 1 May 2007, all investigators* of clinical trials and research studies will be required to show proof that they have completed the SCGCP. Renewal of the certification is necessary whenever the GCP certification has lapsed. The GCP Course is available at the following website: https://www.citiprogram.org and the certification is valid for two years.
  
  * For GCP Course ONLY: Restricted only to all investigators (PI and co-Is) of clinical trials and all investigators of clinical research who have direct contact with patients, even if this is for blood-taking only

(1) New / Initial Submission
Please note that all IRB applications must reach the NCC IRB Secretariat by 4.00pm on the first working day of the month in order for the submissions to be reviewed at the IRB Review Meeting of the month. Only fully completed submissions sent by the stated deadline will be reviewed at the coming IRB meeting. Incomplete submissions will not be reviewed.

Therefore, it is strongly recommended that the applications be submitted at least 1 week before the deadline in order for the IRB Secretariat to check for any missing documents.

The IRB Review Meeting is held on every 3 rd week of the month, except December, where there will not be any meeting.

Guidelines for Submission

1. Completed and signed IRB / DSRB Application Form and applicable Annexes
2. Protocol (with version number, page number and dated)
3. Patient Information Sheet and Consent Forms with version number, page number and dated
4. Clinical Investigator's Brochure or drug monographs for clinical trials - compulsory for all new drugs/indications
5. Questionaires and diaries for subjects (with version number, page number and dated) - if applicable
6. Financial budget and agreement - for studies with financial support
7. Insurance and indemnity - for sponsored studies
8. Subject's compensation guidelines - for sponsored studies
9. Advertisements / Procedures for recruitment - if applicable
10. CV of Principal Investigator
11. CITI Certificates of all investigators
12. GCP Certificates of all investigators (PI and co-Is) of clinical trials and all investigators of clinical research who have direct contact with patients, even if this is for blood-taking only
13. Cheque payment for Industry Sponsored trials (S$500 + prevailing GST) – made payable to “National Cancer Centre”

IRB / DSRB Application Form Instructions
IRB / DSRB Application Form
Annexes	[ A ] [ B ] [ C ] [ D ] [ E ] [ F ] [ G ] [ H ]

(2) Amendment / Additional Document Submission
Amendments and/or additional documents of previously approved studies may be submitted to the IRB at anytime of the year. There is no deadline to submission under this category.

For industry sponsored studies: With effect from 1 Jan 2008, the IRB will impose a review fee of S$100 + prevailing for subsequent protocol amendments.

Required Documents for Submission:

1. Cover letter from the Principal Investigator, requesting for approval of amendment
2. Amendment summary template, detailing changes
3. Amended document with changes highlighted/tracked

Amendment Summary Template
Please note that for submission of amendments, an additional table of amendment summary is required to be attached together. A template of the amendment summary is provided below:

Amendment Summary Template

1. Location of amendment (with reference to the revised document)
2. Original Text
3. Revised Text (amendments in bold)
4. Reason for Change
5. Will change increase risk to participants?

All amendments should have the version numbers and / or dates changed accordingly.

(4) Where Do I Submit the Documents?

The address for all submissions is as follows:
Secretary, NCC Institutional Review Board (IRB)
C/o Division of Clinical Trials & Epidemiological Sciences
Level 4, National Cancer Centre
11, Hospital Drive
Singapore 169610


CONTACT US

Should you have any other enquiries with regards to the IRB, please contact the Secretary at 6436 8253 or the IRB Executive at 6436 8407 during office hours.

Office Hours (except Public Holidays):
Mon – Thu: 8.30am – 6.00pm
Fri: 8.30am – 5.30pm

Or write to us to:
Secretary, NCC Institutional Review Board (IRB)
C/o Division of Clinical Trials & Epidemiological Sciences
Level 4, National Cancer Centre
11, Hospital Drive
Singapore 169610