NSLHD HREC Annual Final Report Form

Northern Sydney Local Health District (NSLHD) Human Research Ethics Committee (HREC)

Annual Progress Report and/or Final Report Form

1. Submission of Annual Reports is a condition of ongoing approval. Reports are due every year on 30 August until the study is complete. 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 for NSLHD Research Governance Officer is not required) 3. This form should be filled in electronically, printed, and signed by the Principal/Coordinating Investigator. Handwritten forms are not accepted by the office. 4. Edit this form by typing in the GREY fields. Delete guidance text prior to submission. 5. FINAL STUDY REPORTS: all sections of this form, including SECTION D must be completed when the study is closed and completed at all sites. 6. Please submit both a hard copy and an electronic copy of the completed report

Hard copies of applications, with original signatures, are to be sent to: Mailing address: Research Office Level 13, Kolling Building IN PERSON – Call x64590 from building reception and a Royal North Shore Hospital team member will come and collect submission from you Pacific Highway Kolling Building - Level 4 (street level reception desk) St Leonards NSW 2065 Royal North Shore Hospital

In addition, an electronic copy of ALL documents submitted must be emailed to [email protected]

A PROJECT DETAILS 1 NSLHD File Number eg. RESP/xx/xx or xxxx-xxxM 2 HREC Reference number eg. HREC/year/HAWKE/xxx 3 Project title

4 Approval date

5 When does HREC approval expire? Date: Refer to original HREC approval letter Is an extension required? YES NO If YES, please submit an amendment request form for consideration of extension to the study. If the study involves recruitment of patients, please contact the Research Office to discuss requirements for ongoing ethical approval, and possible re-submission.

6 Coordinating Investigator name: This is synonymous with Principal email: Investigator for single site studies

NSLHD HREC – September 2014 ANNUAL PROGRESS AND FINAL REPORT FORM (NSW Health GL2010_014 NSW Health GL2010_015) Page 1 of 8 phone: postal address: 7 List Principal Investigators + respective Investigator Site and current site status sites - list all sites approved by NSLHD HREC

8 Research coordinator / contact person name: email: phone: postal address:

9 Have there been any changes to research YES NO personnel since the project was approved? If YES, have these changes been forwarded to the HREC or relevant site Research Governance officer for review? YES NO N/A If NO, please include a Notification of Change of Personnel Form with this report.

B PROGRESS SUMMARY 1 Status of the project PROJECT STATUS DATE If completed prematurely, please If the project has been completed, COMMENCED terminated or abandoned, please provide details: ONGOING complete Section D Final Report COMPLETE

2 Have you received interim results YES NO from the project? If YES, please include details with this form.

3 Does the project involve YES NO N/A (if N/A, continue to question 4) recruitment of participants?

Site name Number of participants ie. direct recruitment via a PISCF consented to date

Have there been delays in recruitment? YES NO If YES, please provide details.

Is recruitment complete? YES NO

NSLHD HREC – September 2014 ANNUAL PROGRESS AND FINAL REPORT FORM (NSW Health GL2010_014 NSW Health GL2010_015) Page 2 of 8 Are participants still actively involved in the study (eg. in follow-up) YES NO

Number of participants withdrawn from study: Provide details of withdrawal: 4 Is this project a data/tissue bank? YES NO (if NO continue to next section) eg. banking/storage of human specimens and/or clinical data Do participants provide informed consent? YES NO If NO please detail why not.

Is clinical information/sample collection ongoing? YES NO Expected date for completion of sample collection:

Are samples linked to personal and/or health information? YES NO

Are samples and/or clinical information sent to other organisations? YES NO

If YES is the information “de-identified”? YES NO

Is there data linkage with other data sources (eg. death or cancer registries)? YES NO

Has a Material Transfer Agreement been executed if the project involves collecting tissue samples from any NSLHD sites and transferring them to another site? YES NO N/A If NO, please detail why not.

C RESEARCH CONDUCT 1 Is the project being conducted in YES NO compliance with the originally approved protocol? Have details of any protocol deviations/violations been forwarded to the HREC Executive for review? YES NO If NO, please do so as soon as possible.

2 Amendments and current Have there been any amendments to the project in the last 12 months?

NSLHD HREC – September 2014 ANNUAL PROGRESS AND FINAL REPORT FORM (NSW Health GL2010_014 NSW Health GL2010_015) Page 3 of 8 approved study documents. YES NO

If YES, have you forwarded them to the HREC Executive Committee for review? YES NO If NO, please do so as soon as possible.

List all currently approved study documents including version/dates and the HREC approval dates for each:

3 Participant Information Sheet and Signed originals of the PISCFs kept in patient medical record? Consent Forms (PIS&CFs) YES NO N/A (if N/A, continue to question 4) If NO, please detail why not: This section is N/A if the study does not involve recruitment of participants with a PISCF Have participants been given a copy of the signed PISCF? YES NO If NO, please detail why not:

Has a ‘research participation’ sticker been placed on the participant’s medical record? YES NO If NO, please do so.

4 Access to Medical Records N/A (please continue to question 5)

Please specify who has access to the Medical Records:

5 Serious Adverse Events (SAEs), Have there been any SAEs, including SUSARs, or otherwise significant events that including SUSARs impact on the study in the last 12 months? YES NO N/A (if N/A or NO, continue to question 6)

If YES, have you informed the HREC of these events? YES NO If NO, please forward these to the HREC immediately.

6 Line listings of SAEs and SUSARs Have line listings been received from the sponsor at least 6-monthly? For commercially sponsored YES NO N/A (if N/A, continue to question 7) studies only If NO, please detail why not:

If YES, have all listings been reviewed by the CI and events of significance reported to the HREC Executive? No, listings not reviewed No, listings reviewed but significant events not reported yet Please report listings to the HREC promptly

NSLHD HREC – September 2014 ANNUAL PROGRESS AND FINAL REPORT FORM (NSW Health GL2010_014 NSW Health GL2010_015) Page 4 of 8 Yes, reviewed but nothing to report Yes, reviewed and reported Insert dates of events reported to the HREC:

7 Issues of ethical significance Have findings of ethical significance arisen at this site or elsewhere? YES NO (if NO, continue to question 8) If YES, please provide details:

Have all participants been informed of these events? YES NO If NO, please detail why not:

8 Data Safety and Monitoring Board Has the DSMB been constituted? YES NO N/A (DSMB) (If N/A, continue to question 9)

Is the DSMB independent of the sponsor? YES NO How many times has the DSMB met? Please describe the key outcomes of the meeting/s and/or attach report if it has not already been submitted to the HREC:

9 Privacy and Confidentiality of Please describe how security and confidentiality of data (includes electronic and Data hard copy) is maintained:

THIS SECTION MUST BE Please list people, by role, who have access to data storage area: COMPLETED FOR ALL STUDIES

Please list people, by role, who have access to data:

10 Quality Control N/A (please continue to question 11)

Please provide details of the quality control checks undertaken, relating to equipment/lab services that are being used in the project, and their frequency:

11 Registration Has the trial been registered with a WHO-accredited clinical trials registry? YES NO N/A (if N/A, continue to question 12) If YES, please provide registration number: If NO, please detail why not:

12 Monitoring / Audit Has the project been audited? YES NO If YES, please attach the auditor’s report:

Has the project been Monitored?

NSLHD HREC – September 2014 ANNUAL PROGRESS AND FINAL REPORT FORM (NSW Health GL2010_014 NSW Health GL2010_015) Page 5 of 8 YES NO If YES, please provide details:

13 Insurance Is the Insurance Certificate current? YES NO N/A (if N/A, continue to question 14) If YES, please provide current certificate number and expiry date:

If No, a current Insurance Certificate must be obtained from the Sponsor and forwarded to the site Research Governance Officer/s directly. 14 Compensation Have any compensation payments (damages) been awarded to any participants as a result of their participation in this study? YES NO N/A If YES, please provide details:

D FINAL REPORT Not applicable

1 Project completion date

2 Lay summary of findings must Please attach an abbreviated clinical summary report per ICH GCP, if applicable. be provided in order for the final report section of this form to be completed. 3 Total number of participants N/A (continue to question 4) recruited at all sites approved by NSLHD HREC

Please list by site, if applicable. 4 Details of publications or reports If no publications arose from study, please detail why not. (including funding reports) accepted or in press.

5 Details of any presentations N/A (continue to question 5) given.

6 Have study participants been YES NO NA informed of the results? Please If YES, please provide details: give details.

7 Have participants been YES NO NA informed which treatment they received? 8 Archiving Period Indefinite Interventional TGA/CTN Scheme; Gene Therapy (after 2000) 15 years Interventional/Clinical research

NSLHD HREC – September 2014 ANNUAL PROGRESS AND FINAL REPORT FORM (NSW Health GL2010_014 NSW Health GL2010_015) Page 6 of 8 Select one option only 5 years Non Interventional/Low Risk projects 12 months Short term/Student projects

3 years Other (eg. Project never commenced, projects were not approved, no participants enrolled)

E. SIGN-OFF I confirm that this project has been conducted as originally approved by NSLHD Human Research Ethics Committee (and subject to any changes subsequently approved as amendments).

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.

Date Name of Coordinating Investigator

Signature of Coordinating Investigator

Contact details for enquiries relating to this report: Name / phone / email

NSLHD Research Office use only – HREC Date Reviewed by HREC Executive:

Action:

Name: Signature:

Designation: Research Ethics Manager | Ethics Officer | HREC Chair/Deputy Chair NSLHD Research Office use only – RGO Date Reviewed by Research Governance Officer:

N/A - no study sites under NSLHD RGO jurisdiction Action:

NSLHD HREC – September 2014 ANNUAL PROGRESS AND FINAL REPORT FORM (NSW Health GL2010_014 NSW Health GL2010_015) Page 7 of 8 Name: Signature:

Designation: Research Governance & Compliance Manager | Research Governance Officer

NSLHD HREC – September 2014 ANNUAL PROGRESS AND FINAL REPORT FORM (NSW Health GL2010_014 NSW Health GL2010_015) Page 8 of 8