St Vincent’s Hospital Sydney
Human Research Ethics Committee
Application Form for an Amendment to an Approved Research Project
Instructions
1.
Please DO NOT submit a cover letter with this form.
2.
This form should be filled in electronically, printed, and signed by the Principal/Coordinating Principal Investigator
only. Electronic signatures are not accepted by the Office.
3.
New sub-studies MUST be submitted to the HREC separately, as new studies, for review. New sub-studies cannot
be submitted as amendments.
4.
The proposed amendment must not be implemented without approval from the Lead HREC and authorisation
from the local Research Governance Officer (for studies reviewed after 1 July 2007)
5.
Information relating to fees and payment is available on the SVH Research Office website at:
http://exwww.stvincents.com.au/researchfees (SVH internal) www.stvincents.com.au/researchfees (external
users). Fees must be paid prior to submission.
6.
Incomplete submissions may be rejected or result in delayed review.
7.
Please submit both a hard copy and an electronic copy (both tracked and clean) of all amended documents.
Electronic copy to be sent to:
SVHS.Research@svha.org.au
The hard copy must have an original signature from the
site Principal Investigator.
Original to be sent to:
Research Office
Level 6, de Lacy Building
St Vincent’s Hospital
390 Victoria St
Darlinghurst NSW 2010
A copy of the signed form should be retained by the Investigator
Research Project Details
SVH File Number
xx/xxx
HREC Ref Number
HREC/year/SVH/xxx
Date of HREC approval expiry?
Date:
Is an extension required?
Yes
No
If YES, please include details for an extension to the study overleaf. If the study
involves recruitment of participants, please contact the Research Office to
discuss requirements for ongoing ethical approval, and possible re-submission.
Date of last annual report submitted?
Date:
Note: An Annual Progress Report must be submitted every year on the approval
anniversary date. The review of this amendment is subject to there being a
current Annual Progress Report on file in the Research Office.
Co-ordinating Principal Investigator
(This is synonymous with Principal Investigator for
single centre projects)
Study Title
Payment Attached
http://exwww.stvincents.com.au/researchfees
(SVH internal)
www.stvincents.com.au/researchfees
Yes
Fee Payment Ref #
N/A
Please attach payment confirmation as failure to do so will result in
delayed review
SVH Research Office Project Amendment Form – Dec 2010 (updated June 2015)
NSW Health GL2013_009, NSW Health GL2010_014, NSW Health GL2010_015
1
D/2014/36003
(external users)
Confirm Electronic Submission
Yes
All documents have been emailed to
SVHS.Research@svha.org.au
Is this a multi-centre study?
Yes
No
If yes, list all sites approved by SVH HREC:
Details of the current study status
(eg. recruitment ongoing, closed to recruitment, all
participants deceased, all participants completed
etc)
Project Amendment Details
List of all Amended documents
List all amended documents submitted including updated versions and date:
Guidance Note: List all documents
exactly as you require them to be listed
on the HREC approval letter and include
tracked and clean versions. For
Investigator Brochure or commercial
protocol amendments, a summary of
changes and clean final document is
sufficient.
Summary of issues relating to
the amendment
Guidance Note: Summarise the rationale
for the request and include relevant
details relating to the ongoing conduct
eg. safety update regarding change in
sample size; amendment to PISCF
clarifying adverse events etc
What are the ethical implications
relating to the amendment?
Guidance Note: Are there any
participants still receiving the study
drug/intervention, is the study closed to
recruitment, are all participants
deceased, is re-consent required, are
changes required to the PISCF?
Has the project commenced at
all sites?
Yes
No
If No, please indicate status at all sites:
Does the amendment require
changes to the Clinical Trial
Research Agreement
Does the amendment require
the TGA CTN form to be
amended?
Yes
No
NA
(If Yes, please forward CTA documents with a cover letter to the Research
Governance Officer for review.)
Yes
No
NA
(If Yes, please forward relevant documents with this form.)
SVH Research Office Project Amendment Form – Dec 2010 (updated June 2015)
NSW Health GL2013_009, NSW Health GL2010_014, NSW Health GL2010_015
2
D/2014/36003
DECLARATION
I confirm that this project has been conducted as originally approved by St Vincent’s Hospital Human
Research Ethics Committee (and subject to any changes subsequently approved as amendments).
I confirm that the above information is accurate, and that the project will continue in accordance with the
original HREC approved protocol, any approved amendments and in compliance with the NHMRC National
Statement on Ethical Conduct in Human Research (NHMRC, 2007).
_____________________________________
Signature of Coordinating Principal Investigator
_
_______
Date
Contact details for enquiries and electronic acknowledgement of this report:
Name:
Phone:
Email:
For projects reviewed by the HREC after 1 July 2007 a copy of the amendment approval letter must be
forwarded to Principal Investigators at each site conducting the project, along with a copy of the approved
documents, for submission to the local Research Governance Officer.
SVH Research Office Project Amendment Form – Dec 2010 (updated June 2015)
NSW Health GL2013_009, NSW Health GL2010_014, NSW Health GL2010_015
3
D/2014/36003