Calvary Health Care Bruce
Human Research Ethics Committee
Request for extension for HREC review - research projects/clinical trial
(Please type in your responses and send the completed form to ethics@calvary-act.com.au)
HREC Reference number
Full title of submission
Original applicant
Current applicant
Contact person
Contact details
Address:
Phone:
Fax:
E-mail:
Original approval dates
......./........../.........
Subsequent approval dates
......../........../..........
Do you have interim results
Yes □
No □
If no, when do you expect interim / final results? If yes,
please provide a brief summary
Page 1 of 4
Is the project being conducted in
accordance with the approved
protocol
Yes □
No □
Does the project involve participant
recruitment
Yes □
No □
Have there been significant events
that impact on the study (SAEs,
SUSARs) in the past 12 months
Yes □
No □
Summarise changes
Have findings of ethical significance
arisen at this site or elsewhere
Yes □
No □
Is recruitment to continue
If Yes, please explain:
Yes □
Have participants been informed of
these events
Yes □
If yes, please provide a
brief summary
If No, detail the changes:
No □
N/A □
No □
Page 2 of 4
Current request extension dates
........./.........../..........
Can you explain in detail the
reasons for extension
Are there changes envisaged to:
Study personnel at Calvary
HCACT Yes □
No □
If yes, please provide brief
summary
Quality control
Yes □
No □
Monitoring /audit of
project Yes □
No □
Date informed: ...../..../.....
State changes:
Page 3 of 4
Insurance Yes □
No □
Compensation
Yes □
State changes:
No □
Supporting documents
(brochures, survey
questionnaire etc)
Yes □
State changes:
If yes, please provide the
clean and tracked versions
of the same
No □
New aims and / or
substantial changes in the
protocol
Yes □
No □
For the single-site studies - In the
continued research, will it develop
into a multi-site study?
Yes □
No □
Have you submitted all progress
and annual reports so far
Yes □
No □
If yes, please provide a
brief summary and a clean
and tracked versions of the
documents
If yes, name the sites and
mention if ethics approval
has been granted to
undertake research in
these sites
Applicant Signature
Applicant Name (print)
Date
......./........../..........
Page 4 of 4