CENTRAL ADELAIDE LOCAL HEALTH NETWORK

Central Adelaide Local Health Network Human Research Ethics Committee
(CALHN HREC)

HREC ANNUAL REVIEW REPORT
The HREC Annual Review Report must be completed by each site for all research studies annually, commencing 12 months from the date of approval, and continuing thereafter annually for the duration of the study. For Annual Progress Report, Extension Request, or Final Report submissions, all sections in the report must be completed in full. For Annual Safety Reports, sections 1 through 3 must be completed. The completed report is to be submitted to the CALHN HREC via
Review reporting is mandatory for all research studiesand is required to be completed at least annually in accordance with the National Health and Medical Research Council (NHMRC) ‘National Statement on Ethical Conduct in Human Research (2007)', theNHMRC ‘Safety monitoring and reporting in clinical trials involving therapeutic goods (2016)’, and as directed by the CALHN HREC

1.STUDY DETAIL

HREC Reference Number: / CALHN Reference Number:
Site Name
*Separate forms must be completed for each Site
Study Title
Site Principal Investigator / Name: / Email:
Department:
Employer:
Trial Coordinator / Name: / Email:
Department:
Employer:

2.ORGINAL APPROVING HREC

☐CALHN HREC
☐RAH REC
☐TQEH/LMH/MH / Central Adelaide Local Health Network Human Research Ethics Committee
Royal Adelaide Hospital Research Ethics Committee
The Queen Elizabeth Hospital/Lyell McEwin Hospital/Modbury HospitalHuman Research Ethics Committee

3.REPORT INTENT – *Mark all boxes that apply

☐Annual Progress Report
☐Annual Safety Report – sponsored studies (Only complete sections 1 through 3 – attach report)
☐Extension Request☐1 year ☐3 years ☐5 years
☐Final Report

4.ETHICS APPROVAL AND STATUS

Study approval period dates / From / To
Last Annual Review Report approval period dates / From / To
Status of the Study for this site / ☐Ongoing
☐Not commenced
☐Terminated
☐Site closed
☐Study complete / Date of anticipated completion
Date of anticipated commencement
Date of termination
Date of Site closure
Date of Study completion

5.RECORD MAINTENACE AND SECURITY

a)What is the current approved Study Protocol version?
b)What is the current approved Investigator Brochure version?
c)What is the current approved Master Participant Information Consent Form(s) (PICFs) version? / Version / Date
d)Are all Study records maintained and stored in accordance with common law, legislative, ethical, and current best practice requirements?
Contact HREC for clarification / ☐Yes
☐No► / Contact HREC immediately

6.STANDARD OF CARE

a)Has a change procedure for Standard of Care occurred during the course of this study? / ☐Yes
☐No► / Go to 7a
b)Have the Protocol and / or PICF(s) above been amended accordingly? / ☐Yes
☐No► / Attach updated documentation

7.STUDY SAMPLES

a)Does the study involve the collection of samples? / ☐Yes
☐No► / Go to 8a
b)Will samples be stored for future research use? / ☐Yes
☐No► / Go to 8a
c)Does the PICF(s) request consent for storage and future use? / ☐Yes
☐No► / Attach updated documentation

8.PARTICIPANT MONITORING

a)How many participants have been recruited into the Study? / Number of patients
Number of staff
Number of volunteers
Others
b)Have any participants been withdrawn from the Study by the investigator or sponsor? / ☐Yes►
☐No / Number of participants
c)Have any participants withdrawn themselves from Study voluntarily? / ☐Yes►
☐No / Number of participants
d)Have any related, or possibly-related Protocol Deviations / Violations (PD/Vs) occurred? / ☐Yes►
☐No► / Number of PD/Vs
Go to 8f
e)Have they been reported to HREC? / ☐Yes
☐No► / Attach documentation
f)Have any Serious Adverse Events (SAEs) have occurred? / ☐Yes►
☐No► / Number of SAEs
Go to 9a
g)Have they been reported to HREC? / ☐Yes
☐No► / Attach documentation

9.PROGRESS UPDATE

Provide a brief update on the progress to date, or outcome in the case of completed research
* If the study has not commenced, rationale must be provided
*If the study has been terminated prematurely, a statement confirming that no participants will be disadvantage as a result of thetermination should be documented where possible
*If any participants have been withdrawn from the study by the investigator or sponsor, rationale must be provided

10.ENDORSEMENT

SITE PRINCIPAL INVESTIGATOR
I certify that this Study, of which I am a Principal Investigator has complied with the conditions, and any applicable specified conditions, of ethical approval including; Good Clinical Practice ‘GCP’, International Council for Harmonisation ‘ICH’, and National Health Medical Research Council ‘NHMRC’ guidelines, maintenance and security of records, and procedures for consent / COORDINATING PRINCIPAL INVESTIGATOR
I certify that this Study, of which I am a Principal Investigator has complied with the conditions, and any applicable specified conditions, of ethical approval including; Good Clinical Practice ‘GCP’, International Council for Harmonisation ‘ICH’, and National Health Medical Research Council ‘NHMRC’ guidelines, maintenance and security of records, and procedures for consent
Name: / Name:
Date / Date

The Site Principal investigator and the Coordinating Principal Investigator must be copied into the submission email in lieu of signatures

Enquiries to

Version 5.0, March 2018

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