Sydney Children’s Hospitals Network
Human Research Ethics Committee
Annual Progress and / or Final Report
Submission Instructions - Annual Report and / or Final Report
· Annual Progress Reports are due annually on the date of study approval until the study is completed.
· Submission of Annual Reports is a condition of ongoing ethics approval.
· A Final Report is due when the study is closed and completed at all SCHN approved sites.
· Please review and complete all questions relevant to your study.
· Please submit an electronic copy of this form only to .
PROJECT SPECIFIC DETAILS
HREC Reference NumberProject Title
Coordinating Principal Investigator (CPI)
Email for CPI (organisational)
Department & Organisation
Contact for Correspondence
Email for Correspondence (organisational)
Date of HREC Approval
Date Ethics Approval Expires
Is the study Multi-Centre / Single Centre? / Choose an item.
Reporting Period (Mandatory Field)
(please insert date range –
e.g. 01 January 2016 – 01 January 2017)
1. Please list all sites approved under this ethics approval and the Site Principal Investigator.
Site Name / Principal Investigator2. Have there been any changes made to study personnel or site(s) since initial approval that the SCHN HREC has not yet been advised of? ☐ YES ☐ NO
If yes, please provide details:
Click here to enter text.3. Is this study a registered Clinical Trial? ☐ YES ☐ NO
If yes, please provide the registration no.: Click here to enter text.
4. Does the project require an extension of ethics approval?
☐ YES – proceed to question 5. ☐ NO – proceed to question 6.
5. Do you anticipate that the project will be completed in less than 12 months after the current ethics approval expiry date? ☐ YES ☐ NO
· If yes, please submit an amendment application
· If no, please submit a renewal application
progress of project
6. Current Project Status: ☐ Not Yet Commenced ☐ In Progress ☐ Completed ☐ Terminated / Abandoned
7. Date Project Commenced: Click here to enter text.
8. How is the project being funded? ☐ Commercially Funded ☐ Competitive Grant Funded ☐ Self-Funded / No Funding
9. Are there sufficient funds available to complete the research? ☐ YES ☐ NO
If no, please outline what strategies are in place to manage the shortfall:
Click here to enter text.10. Does the project involve the recruitment of participants?
☐ YES – please complete the table below. ☐NO – proceed to question 11.
Please provide the number of participants recruited at each site to date. / Click here to enter text.Is recruitment on target? / Choose an item.
Is recruitment complete? / Choose an item.
Are participants still actively involved in the study (e.g. in follow-up)?
If yes, please describe the nature of their involvement. / Click here to enter text.
If recruitment is not on target, please explain why and detail strategies that will be utilised to address this issue. / Click here to enter text.
Have any participants withdrawn from the study? / Choose an item.
If yes, how many? Click here to enter text.
Have any participants been withdrawn by the investigators? / Choose an item.
If yes, how many? Click here to enter text.
Please explain the reasons / circumstances for the abovementioned participant withdrawals (if available). / Click here to enter text.
11. Please specify what data collection has been completed to date / yet to be completed.
· e.g. for medical record reviews please specify how many records have been accessed to date and how many total records are required for your research.
Click here to enter text.Research Conduct
12. What are the version details of the current protocol in use: Click here to enter text.
13. Date version approved: Click here to enter text.
14. Have there been any protocol deviations during this reporting period?
☐ YES - Please attach list of protocol deviations ☐ NO
15. Have all protocol violations been reported to the HREC?
☐ YES ☐ NO - Please report to the Research Ethics Office ASAP.
16. Have all amendments to the project been reported to the HREC?
☐ YES ☐ NO - Please submit an amendment application to the Research Ethics Office ASAP.
17. Has the project been audited? ☐ YES – Please attach the auditor’s report. ☐ NO
18. Does your project involve contact with participants?
☐ YES - Please complete and attach an SCHN Annual Safety Report ☐ NO
Privacy and Confidentiality
19. Please describe how the security and confidentiality of data (including electronic and hard copy) is maintained:
Click here to enter text.FINAL REPORT ☐ Please select if NOT Applicable and proceed to Declaration
20. Project completion date: Click here to enter text.
21. Please attach a lay summary of findings as a separate document.
☐ Attached (Note: A Final report will not be accepted without a lay summary.)
22. Total number of participants recruited at SCHN sites and then all sites approved by the SCHN HREC:
Click here to enter text.23. Details of publications, reports (including funding reports) accepted or in press or presentations:
Click here to enter text.24. Have study participants been informed of the results? ☐ YES ☐ NO
25. Archiving (select one option only):
☐ Indefinite Interventional TGA / CTN Scheme; Gene Therapy (after 2000)
☐ 15 Years (or till youngest child reaches 25 Interventional / Clinical Research
☐ 5 Years Non-interventional / Low Risk Projects
Declaration
I confirm that this project has been conducted as approved (originally and through amendment) by the Sydney Children's Hospitals Network Human Research Ethics Committee.
I confirm that this project continues to be conducted in compliance with the NHMRC National Statement on Ethical Conduct in Human Research (NHMRC, 2007).
I confirm that this report accurately reflects the progress of the project.
Name of Coordinating Investigator: Click here to enter text.
Date: Click here to enter text.
Official Use: To be completed by SCHN Research Ethics Office
Acknowledgement of ReportThe Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC) acknowledges receipt of this annual / final report and notes that the general conditions of ethics approval have been satisfied
Supporting Documents Considered / Version / Date
Next Report Due
Name: / Click here to enter text. / Position: / Click here to enter text.
Signature: / Date: / Click here to enter text.
NB: Once acknowledged by the SCHN HREC, a copy of this report must be forwarded to the Research Governance Officer at each site for governance Consideration
Annual Report Form – v4 – 26 October 2017