Sydney Children’s Hospitals Network

Human Research Ethics Committee

Annual Progress and / or Final Report

Submission Instructions - Annual Reportand / 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 allquestions relevant to your study.
  • Please submit an electronic copy of this form only to .

PROJECT SPECIFIC DETAILS

HREC Reference Number
Project Title
Coordinating Principal Investigator(CPI)
Email for CPI(organisational)
Department
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
(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 Investigator
  1. 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. /
  1. Is this study a registered Clinical Trial? ☐YES ☐NO

If yes,please provide the registration no.:Click here to enter text.

  1. Does the project require an extension of ethics approval?

☐YES – proceed to question 5. ☐NO – proceed to question 6.

  1. Do you anticipate that the project will be completed in less than 12 months after the current ethics approval expiry date? ☐YES ☐NO
  2. If yes,please submit an amendment application
  3. If no, please submit a renewal application

progress of project

  1. Current Project Status:☐Not Yet Commenced ☐In Progress ☐Completed ☐Terminated / Abandoned
  1. Date Project Commenced: Click here to enter text.
  1. How is the project being funded?☐Commercially Funded☐Competitive Grant Funded☐Self-Funded / No Funding
  1. 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. /
  1. 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. /
  1. Please specify what data collection has been completed to date / yet to be completed.
  2. 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

  1. What are the version details of the current protocol in use:Click here to enter text.
  1. Date version approved: Click here to enter text.
  1. Have all protocol deviations / violations been reported to the HREC?

☐YES ☐NO- Please report to the Research Ethics Office ASAP.

  1. Have all amendments to the project been reported to the HREC?

☐YES ☐NO- Please submit an amendment applicationto the Research Ethics Office ASAP.

  1. Have all adverse events, including SUSARs, protocol deviation or violations that have impacted on the conduct of the study or patient safety in the last 12 months been reported to the HREC?

☐YES ☐NO

If no, please provide details:

Click here to enter text. /
  1. Has a DSMB been constituted?☐YES – proceed to question 18 ☐NO / NA – proceed to question 21.
  1. Is the DSMB independent of the sponsor? ☐YES ☐NO
  1. Please provide details of any key outcomes or relevant safety concerns identified by the DSMB that may affect ethics approval:

Click here to enter text. /
  1. Have any of these key outcomes or relevant safety concerns not yet been reported to the Committee? ☐ YES – Please report these ASAP ☐NO
  1. Has the project been audited? ☐YES – Please attach the auditor’s report.☐NO

Privacy and Confidentiality

  1. Please describe how the security and confidentiality of data (including electronic and hard copy) is maintained:

Click here to enter text. /

FINAL REPORT☐Pleaseselect if Not Applicable and proceed to Declaration

  1. Project completion date: Click here to enter text.
  1. Please attach a lay summary of findings as a separate document.

☐Attached(Note: A Final report will not be accepted without a lay summary.)

  1. Total number of participants recruited at SCHN sites and then all sites approved by the SCHN HREC:

Click here to enter text. /
  1. Details of publications, reports (including funding reports) accepted or in press or presentations:

Click here to enter text. /
  1. Have study participants been informed of the results?☐YES ☐NO
  1. Archiving (select one option only):

☐IndefiniteInterventional TGA / CTN Scheme; Gene Therapy (after 2000)

☐15 Years (or till youngest child reaches 25Interventional / Clinical Research

☐5 YearsNon-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.

Annual Report Form – v3 – 20 September 2017