NEAF Submission checklist – SCHN HREC

  • Please ensure that you have read and understood the NEAF quick submission guideline available on the SCHN Research Ethics Internet pagewhen preparing your application.
  • This checklist is for new NEAF applications only.
  • Submission is fully electronic – no hard copy is required.
  • Applications that are incomplete or do not follow the submission guideline will not be accepted for review.

Date / Click here to enter a date. /
Project Title / Click here to enter text. /
Study Type
Please refer to this link for definitions of each study type. / Choose an item. /
Department & Institution / Click here to enter text. /
Principal Investigator/s / Click here to enter text. /
Associate Investigator /s / Click here to enter text. /
Sites for review by the SCHN HREC / Click here to enter text. /
Contact for Application / Click here to enter text. /
Contact Email(organisational) / Click here to enter text. /
Contact Telephone / Click here to enter text. /
Type of Funding / Choose an item. /
Is this study a Multi-jurisdictional low and negligible risk (LNR)? / Choose an item. /

Investigator Initiated Studies Only

-Have your study protocol and scientific documentation been peer reviewed by the SCHN Scientific Advisory Committee?

☐Yes☐No

Your application is not ready for submission. Please refer to the SCHN

HREC NEAF Quick Submission Guideline available on the SCHN Research Ethics’ Internet page.

-Have the Peer Reviewers endorsed your project and confirmed to you that they will submit their Reviewer reports on this submission closing date?

☐Yes☐No

Your application is not ready for submission. Please liaise directly with your Peer Reviewers to make appropriate arrangements.

-What is your study’s peer review reference number? (This number would have been issued to you by the Research Ethics Office during the peer review process) Click here to enter text.

Clinical Trials

The trial is being conducted through:

☐CTN ☐CTX☐Other

Please specify: Click here to enter text.

Indicate the phase of your clinical trial:

☐Phase I ☐Phase II ☐Phase III ☐Phase IV ☐Other (e.g. pilot)

Please specify: Click here to enter text.

What is the current status of the trial’s drug/device/therapeutic good in Australia? Click here to enter text.

Document SubmissionChecklist

Investigator Initiated / Commercially Sponsored, Large Collaborative Group and NHMRC Funded / Multi-jurisdictional low and negligible risk
National Ethics Application Form (NEAF) / ☐ / ☐ / ☐ /
Electronic signatures or scanned signature page including the Heads of Departments signature / ☐ / ☐ / ☐ /
Protocol / ☐ / ☐ / ☐ /
Investigator Brochure/Product Information (if applicable) / ☐ / ☐ /
Master Participant/Parent Information Sheets and Consent Forms (if applicable) / ☐ / ☐ / ☐ /
All Research Tools that will be used (for example, questionnaires, focus group questions, surveys) / ☐ / ☐ / ☐ /
All Advertising Materials that will be used (if applicable) / ☐ / ☐ / ☐ /
For applications involving radiation in excess of Clinical Care, a report from the Radiation Safety Officer at the Sites within the SCHN at which the study will be conducted. / ☐ / ☐ /
Invoicing Authorisation Form (if applicable) / ☐ / ☐ / ☐ /
For all Victorian sites - The Victorian Specific Module / ☐ / ☐ / ☐ /
Application for Waiver of Consent form (if applicable) / ☐ / ☐ / ☐ /
For NHMRC funded projects only – the NHMRC grant approval letter / ☐ /
For commercially sponsored, multi-centre studies that involve non-SCHN sites - Medicines Australia Form of Indemnity (HREC review only) / ☐ /

Document Submission List

IMPORTANT

-Please save your documents according to the following naming convention:

Type of document (e.g. protocol) – version number – date

Examples: Protocol – Version 2 – 1 October 2016

Parent Info Sheet & Consent – Master V2 – 20Sep2016

-Please make sure that each document (excluding the NEAF) has the version number and date mentioned in the document footer/header. Documents without this information will be rejected.

Please list the submission documents in the below table:

Document / Version / Date
NEAF, Submission Code: / N/A

If the space provided above is insufficient to list all study documentation, please attach a separate sheet.

NEAF Submission Checklist - V2 - Dec 2016