Northern Sydney Local Health District (NSLHD)
Annual/Final Research Report to Institution
1. Submission of Annual Reports is a condition of ongoing ethics and/or governance approval. Reports
are due every year on the 30 August until the study is completed and a summary of results of available.
2. For multi-centre studies with lead ethics approval by NSLHD HREC, one report (incorporating information
relating to any sub-studies conducted under the same file number) should be submitted by the Coordinating
Investigator (a separate report to the NSLHD Research Governance Officer is not required)
3. For studies with lead ethics approval from an HREC other than NSLHD HREC (ie. governance only), this report
must be completed in addition to any reports which must be submitted to the lead HREC.
4. This form should be filled in electronically and emailed to the Research Office. One hard copy must also be
submitted. Electronic signatures are acceptable, however, if a study coordinator is submitting on behalf of the
Principal Investigator (PI), the PI must be cc’d on any correspondence.
5. YOU MAY NOT NEED TO COMPLETE ALL SECTIONS OF THIS REPORT. DELETE SECTIONS THAT DO
NOT APPLY TO YOUR STUDY
A. Administrative details: complete for all reports
B. PROGRESS SUMMARY B: Complete for studies which involve participant recruitment
PROGRESS SUMMARY B.1: Complete for studies which involve tissue banking
C. PROGRESS SUMMARY C: Complete for studies which do not involve direct participant
recruitment (use of banked tissue and/or data banking, anonymous surveys, medical record
review etc)
D. PROGRESS SUMMARY D: Complete for all clinical trials, or other studies sponsored by a
commercial entity or collaborative research group
E. FINAL REPORT: complete for all completed studies, in addition to other relevant sections
This report, with Coordinating/Principal Investigator
signature (electronic or scanned) must be emailed to
NSLHD-Research@health.nsw.gov.au.
A
1
Please also submit one hard copy:
Post: Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
In person
Kolling Building level 4 (ground
floor lobby)
ADMINISTRATIVE DETAILS: complete for all projects
What type of report is this?
Annual ☐
Section E cannot be left blank if this
Final ☐
is a final report
2
3
4
5
6
7
8
B
1
2
NSLHD File Number
eg. RESP/xx/xx or xxxx-xxxM
HREC Reference number
eg. HREC/year/HAWKE/xxx
Project title
HREC approval expiry date
Coordinating/Principal
Investigator
Current status at all sites
approved by NSLHD HREC or
RGO
Investigator
name at site
Site name
Current status (active, not yet
active, complete, terminated,
abandoned)
If a site has not yet commenced, or
has been terminated/abandoned,
please provide the reason.
Please confirm that any personnel
changes in the last 12 months
have been submitted for HREC
and/or RGO review
☐Yes – all notifications submitted previously
☐Yes – submitted with this report (completed per instructions on Change in
Personnel Form)
☐No – no changes in personnel in last 12 months
PROGRESS SUMMARY B: Complete for studies which involve participant recruitment (please list
information for all NSLHD sites, AND, if applicable, sites approved by NSLHD HREC)
Date of first patient recruited at NSLHD
Is recruitment on target per the anticipated number in the
Site Specific Assessment and/or feasibility assessment?
NSLHD Institutional Research Report – July 2015 v1
DELAYED
☐- provide reason for delay
Page 1 of 4
ON TARGET
COMPLETE
3
4
5
☐
☐
Total number of participants enrolled (by site, if
applicable)
Number of participants withdrawn from study (provide
reason for withdrawal)
Number of participants screened but not enrolled
Does the study involve tissue banking?
6
☐No – delete section B1
☐Yes – storage and use of tissue is dealt with in study
contracts (eg. formal commercial or
collaborative group CTRA is in place)
DELETE section B1
☐Yes – study without formal contracts which cover
tissue use/banking
COMPLETE section B1
B1
1
2
TISSUE BANKING
Number of specimens collected to-date
Location at which specimens are stored
Have the specimens been used for other research
projects?
3
C
1
2
3
4
5
☐No
☐Yes – please provide the following:
 HREC approval number for use of tissue
(NSLHD reference #, or if not approved by
NSLHD HREC, attach relevant HREC approval
letter)
 Copy of Material Transfer Agreement (if
specimens transferred to another institution)
 Number of specimens used to-date
PROGRESS SUMMARY C - Complete for studies which do not involve direct participant recruitment
(use of banked tissue and/or databases, medical record review etc)
Please list information for all NSLHD sites, AND, if applicable, sites approved by NSLHD HREC
Date study commenced at NSLHD
Total number of records accessed in database OR
Total number of specimens accessed
Number of records screened prior to use in dataset or
specimen use
Source of data/tissue (eg. medical records, or approved
research database/tissue bank – specify which
database/tissue bank)
Specific location at which data is stored/held (eg.
Departmental computers on NSLHD servers, specific
locked filing cupboard, University servers etc)
1
PROGRESS SUMMARY D - Complete for all clinical trials, or other studies sponsored by a commercial
entity or collaborative research group
Insurance certificate number and expiry date
2
Clinical trial registration number
3
Please confirm that all DSMB/safety monitoring reports
from the last 12 months have been submitted
☐Yes – all reports submitted
☐No – submitted with this report
☐No – no safety/DSMB reports in last 12 months
4
If the study has been audited, either by the sponsor or by
an external regulatory body, at any NSLHD sites (or sites
under the jurisdiction of NSLHD HREC), please confirm
that the audit report has been submitted
☐Not audited
☐Audited and report submitted previously
☐Audited, report submitted with this progress report
5
Please confirm that any interim analyses from the last 12
months have been submitted
☐Yes – all reports submitted
☐No – submitted with this report
☐No – no analyses conducted in last 12 months
D
NSLHD Institutional Research Report – July 2015 v1
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If N/A, delete this section - The final report should not be submitted if data
E
FINAL REPORT
1
Project completion date
2
Lay summary of findings
analysis is ongoing. If a global study sponsor requires ongoing submission of
regulatory documents for review by the HREC, even if a study has closed in
Australia, do not submit a final report.
Provide details of publications,
presentations given or reports
(including funding reports)
accepted or in press
3
Archiving Period (per NSW
State Records Act GDA17)
Please note that these periods
apply from the date of final
publication or termination of the
study
4
☐Indefinite
☐15 years
☐5 years
☐3 years
Interventional TGA/CTN Scheme; Gene Therapy (after 2000
– per Code for Responsible Conduct of Research)
Interventional/Clinical research (GDA17 8.1.1)
Non Interventional/Low Risk projects (GDA17 8.1.2)
Other (eg. Project never commenced, projects were not
approved, no participants enrolled) (GDA17 8.1.5)
Select one option only
F SIGN-OFF BY COORDINATING/PRINCIPAL INVESTIGATOR
By signing the declaration below, you are confirming the following:
1. This project is being/has been conducted as originally approved by the relevant ethics committee
(and subject to any changes subsequently approved as amendments)
2. This project continues to be conducted in compliance with the NHMRC National Statement on
Ethical Conduct in Human Research (NHMRC, 2007) and relevant institutional requirements of
NSLHD
3. All amendments have been submitted for HREC and/or RGO review prior to implementation
4. All relevant safety reports have been submitted for HREC and/or RGO review
5. All protocol deviations/violations have been reported (per NSW GL2010_014 section 11)
6. The HREC and/or RGO have been notified of any changed in personnel in the last 12 months
7. This report accurately reflects the progress of the project
Name of Coordinating Investigator
Signature of Coordinating
Investigator
Date
Contact details for enquiries relating to this report:
Name / phone / email
NSLHD Research Office use only – HREC
Date Reviewed by HREC Executive:
NSLHD Institutional Research Report – July 2015 v1
Page 3 of 4
Action:
Name:
Signature:
Research Ethics Manager | HREC Chair | Ethics Officer | RCGM
NSLHD Research Office use only – RGO
Date Reviewed by Research Governance Officer:
Action:
Name:
Signature:
Research Governance Officer | RCGM
NSLHD Institutional Research Report – July 2015 v1
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