☐RAH –Royal Adelaide Hospital Research Ethic Committee
☐TQEH –The Queen Elizabeth Hospital Human Research Ethics Committee (TQEH/LMH/MH)
☐Requesting Approval Extension– 1 year ☐3 years ☐5 years ☐Annual Progress Report only☐
HREC Reference Number:HREC/// / CALHN Reference Number: / Site Name:(separate forms to be completed for each site)
Study Title
Site Principal Investigator / Name: / Email:
Dept & Institution:
Trial Coordinator / Name: / Email:
ETHICS APPROVAL DATE AND LAST PERIOD OF APPROVAL
Original Approval date: / Last Period of Approval:
Status of the project for this site: Please complete brief report on reverse, or attach report.
☐Ongoing Date of anticipated completion: // ☐Completed Date of completion: //
☐Not Commenced: If not commenced, will the project recommence?☐Yes approx. date: // ☐No
STUDY DOCUMENTS
Current Approved Study Protocol (version/date):
Current Approved Investigator Brochure (version/date):
Current Approved Participant Information Sheet(s) (version/date):
Does this study collect samples:☐Yes ☐No If yes, will samples be stored for future research use? ☐Yes ☐No
Does the PICF request consent for storage and future use☐Yes ☐No, if no please contact HREC office to discuss
PARTICIPANT MONITORING
Overall number of participants randomised into study.
Patients: / Staff: / Healthy Volunteers: / Others:
Number of participants withdrawn from the study by investigators/sponsor.
Please give reason(s) for each withdrawal.
Number of participants who withdrew themselves from study voluntarily.
How many possibly-related Serious Adverse Events have occurred?
Have they been reported to the HREC? ☐Yes ☐No, If not, please attach details
How many Protocol Deviations/Violations have occurred?
Have they been reported to the HREC? ☐Yes ☐No, If not, please attach details.
Give a brief progress report, or completion report:
INVOICE BILLING DETAILSIt is the responsibility of the PI to advise HREC office of any changes to billing details
Have study billing details changed ☐Yes ☐No ☐N/A
If Yes, please complete details below.
Company Name:
Company Address:
Study Coordinator: / SC Contact No:
Company Protocol # / Invoicedetails required by Sponsor / Sponsor Site Code
Email Address:
Contact Name: / Contact No:
SITE PRINCIPAL INVESTIGATOR:
I certify that this research project, of which I am a Principal Investigator has complied with the conditions (and any applicable specified conditions) of ethical approval including GCP (Good Clinical Practice), ICH and NHMRC guidelines, maintenance and security of records and procedures for consent. / COORDINATING PRINCIPAL INVESTIGATOR:
I certify that this research project, of which I am a Principal Investigator has complied with the conditions (and any applicable specified conditions) of ethical approval including GCP (Good Clinical Practice), ICH and NHMRC guidelines, maintenance and security of records and procedures for consent.
NAME: / NAME:
DATE: / DATE:
Please ensure that both the Site PI and the CPI are cc’d into the submission email in lieu of signatures
Once completed, please send this form to the lead HREC:
CALHN, Version 2, dated 30 May 2017