MSF1: CHECKLIST FOR RESEARCHERS FOR NEW PROTOCOL SUBMISSIONS
HUMAN RESEARCH ETHICS COMMITTEE
Please forward with your submission to
the Human Research Ethics Committee
1 NEAF (1 original and 17 copies) (completed and locked)
Ensuring all relevant signatures from Department Directors have been obtained
2 HREC - Application/Submission Form (1 original)
3 Participant Information & Consent Forms (1 original + 17 copies) Version,date + page number
including revocation of consent
4 For experimental drugs: CTX/CTN Form
Overseas Regulatory Status
Investigator's Brochure (4 Copies)
Indemnity Form (Draft)
Contract / Agreements (Draft)
Current Certificate of Insurance
5 Radiation Safety Committee Approval, if applicable.
6 Is this work towards a degree/diploma, etc? Yes / No
If so, include Supervisor's name and position and Supervisor's written approval
Questionnaires, diaries, advertisements, data collection forms, brochures
7 and product information included.
8 Submission documents are bundled , ready for distribution to HREC members
Bundle = 1 Cover letter, 1 NEAF, 1 Protocol, 1 PICF, etc
A copy of all submission documents has been kept by the PI for auditing and
10 On site sponsor arranged.
(enclose supporting letter signed by all relevant Heads of Department)
11 A Site Specific Assessment Form - SSA (signed by all relevant Directors of Department/s)
( https://www.ethicsform.org/au/SignIn.aspx )
12 Fully sponsored trials attract a Protocol Levy.
Is this Trial a fully sponsored trial? Yes / No
If yes, has an Invoice Memo been raised? Yes / No
(Invoice Request Memo to A Gavrillidis Director Research Development & Ethics, CHR)
Version 2, 10 June 2010