St Vincent’s Hospital (Melbourne)
Research Governance Unit
Human Research Ethics Committee
Supplementary Cover sheet for SERP applications – Request for Amendment
NOTES:
1. This supplementary form should be completed and submitted with the CCHRE amendment form:
http://www.health.vic.gov.au/cchre/downloads/hrec_amendment_form.pdf
2. If the amendment only relates to the addition or removal of a member of the research team then please
complete the ‘Change Members of Research Team’ Form
http://www.svhm.org.au/research/governance/Documents/form_change_res.doc
1
Does the proposed amendment(s) involve the collection, use or disclosure of personal
information not considered in the original application or a subsequent amendment?
Yes
No
If yes, then also attach Module 3 of the Victorian Specific Module.
2.
Does this Request for Amendment also include changes to the research team
Yes
No
If yes, then also complete the ‘Change Members of Research Team’ Form
3
Please identify if the proposed amendments also involve amendments to the following
documents and then follow the instructions
Tick Yes
or No:
Yes
Document:
Instructions – Paper Copies:
NEAF
Amend all relevant sections of the current version of the NEAF and/or
Victorian Specific Module submit:
1. 2 highlighted/marked sections which have changed (NEAF)
and/or Victorian Specific Module
2. 1 clean copy of the amended pages
No
Yes
No
Victorian
Specific
Module
Yes
SSA
No
Note: Version number and date of the document must be updated
Amend all relevant sections of the current version of the SSA
1. 2 copies of the amended pages with track changes (CAF) or
highlighted/marked sections which have changed (NEAF)
2. 1 clean copy of the amended pages
Electronic
Copies:
1 clean copy
uploaded onto
the on-line
forms website
1 clean copy
uploaded onto
the on-line
forms website
1 clean copy
uploaded onto
the on-line
forms website
Note: Version number and date of the document must be updated
Yes
PICF
No
Amend the current version of the PICF and submit:
1. 2 copies with track changes
2. 1 clean copy
1 clean copy
uploaded onto
the on-line
forms website
Note: Version number and date of the document must be updated
consistently in all places throughout the document.
Yes
Investigators
Brochure
No
Changes to the Investigator’s Brochure (IB) must be clearly
presented.
This can be achieved by either:
 Submit 2 copies of the revised IB with all changes track
changed, highlighted or marked throughout the IB.
Or
 Submit 2 copies of a summary of the exact changes and 1
copy of the updated IB.
Note: The Summary of Changes must list the relevant section heading by
number and name followed by a heading ‘Text was previously’ (or similar
heading) then [insert previous text] followed by a heading ‘Text is now’ (or
Version: v3.0
Amended by: Jacqui Hastings
Page 1 of 3
Date: 30August 2010
1 clean copy
uploaded onto
the on-line
forms website
similar heading) then [insert revised text].
Note: A track changed, highlighted or marked copy of the IB is not required if
an exact summary of changes is provided. If an exact summary of changes
is not provided then a track changed, highlighted or marked copy is required
to assist the committee member(s) identify where the changes are located
within the document.
Yes
Clinical
Protocol
No
Changes to the Clinical Protocol (CP) must be clearly presented.
This can be achieved by either:
 Submit 2 copies of the revised CP with all changes track
changed, highlighted or marked throughout the CP.
Or
 Submit 2 copies of a Summary of Changes and 1 copy of the
updated CP.
1 clean copy
uploaded onto
the on-line
forms website
Note: The Summary of Changes must list the relevant section heading by
number and name followed by a heading ‘Text was previously’ (or similar
heading) then [insert previous text] followed by a heading ‘Text is now’ (or
similar heading) then [insert revised text].
Note: A track changed, highlighted or marked copy of the IB is not required if
an exact summary of changes is provided. If an exact summary of changes
is not provided then a track changed, highlighted or marked copy is required
to assist the committee member(s) identify where the changes are located
within the document.
Yes
No
4
Other, please
specify (eg
questionnaire,
patent diary)
If a new document, please attach 2 copies of the new document.
If the document is amended, please attach:
1. 2 copies with amendments track changed, highlighted or
marked
2. 1 clean copy of the document
1 clean copy
uploaded onto
the on-line
forms website
Institutional Overheads Charge
Note: An IOC is charged for amendments for commercially and some collaborative group trials.
Institutional Overheads Charges
Commercially funded study amendment (both reviewing and
participating sites)
Addition of another site for which St Vincent’s Hospital
(Melbourne) will be responsible for
Commercially funded study administrative amendment (including
minor changes to the IB which do not result in changes to the
Participant Information and Consent Form/Clinical Protocol, both
reviewing and participating sites)
Collaborative group study amendment (both reviewing and
participating sites)
5
AUD$650.00 + GST
AUD$100 + GST
AUD$100 + GST
AUD$600.00 + GST
Payment
Payment to be made by sponsor
Provide Invoice details below so that a complying tax invoice can be generated.
Payment to be made by Principal Researcher affiliated with BOBIM
An invoice will be sent automatically to BOBIM after each HREC deadline.
Payment to be made by Principal Researcher affiliated with external organisations
Provide Invoice details below so that a complying tax invoice can be generated.
Payment to be made by Principal Researcher affiliated with SVH Departments
Complete Internal Costing Transfer details below
Version: v3.0
Amended by: Jacqui Hastings
Page 2 of 3
Date: 30August 2010
Invoice details
Institution name:
Department:
Name:
Postal address:
Phone number:
Fax number:
Email address:
Internal Costing Transfer details
The fee is being paid from this account, ie DEBIT FROM (add expense to):
Department:
Cost centre
Subjective code
Signature
Amount
Authorised by
Date
RGU use only:
The fee is being paid to this account, ie CREDIT TO (remove expense from):
Cost centre
Subjective code
Amount
Authorised by
RS207
38510
Signature
Date
Finance department – Please identify as HREC Protocol No:
Report
_______________ on the Finance
RGU use only:
Confirmed by HREC Secretary
Version: v3.0
Amended by: Jacqui Hastings
Page 3 of 3
Date: 30August 2010