/ HUMAN RESEARCH ETHICS
Interventions, Therapies and Trials Module
Ethics ID:
Project Title:
  1. Types of Trial

Will the proposed research involve drugs or therapeutic devices or both?
Note: if your proposed research will involve both drugs and therapeutic devices, you should complete both section 2 and section 3 of this form.
Drugs (CompleteSection 2)
Therapeutic devices(CompleteSection 3)
Both drugs and therapeutic devices(Complete Sections 2 & 3)
  1. Projects Involving Drugs

  1. Drug usage
/ Provide details of how the drug will be used.
Phase I / Phase II / Phase III / Phase IV
First use in humans? / First use in patient?
  1. Registration of drugs
/ Is the drug registered in Australia by the Therapeutic Goods Administration?
No(Proceed to question D)
Yes(Give details below)
If Yes, under what name is the drug registered?
  1. Dosage administration
/ Is the dosage, administration, indications for use or age group of participants proposed for this project different from the Australian approved product information?
No (Proceed to question D)
Yes(Give details below)
If Yes, provide justification, including a summary of the most up-to-date information, to support the unapproved use in this project.
  1. Regulatory authorities for this indication
/ Has the drug been registered/licensed/approved for marketing for this indication by an accepted international regulatory authority (other than the Australian Therapeutic Goods Administration)?
No (Proceed to question E)
Yes(Give details below)
If Yes, identify countries and/or regulatory authorities that have registered, licensed or approved the drug.
  1. Regulatory authorities for other indications
/ Has the drug been registered, licensed or approved for marketing for other indications by an accepted international regulatory authority (other than the Australian Therapeutic Goods Administration)?
No (Proceed to question F)
Yes (Give details below)
If Yes, identify countries and/or regulatory authorities that have registered, licensed or approved the drug and give details of the other indication(s) for which the drug is registered, licensed or approved.
  1. Drug review
/ Has the drug been reviewed for investigational or research uses by an international regulatory authority?
No(Proceed to question I)
Yes(Give details below)
If Yes, provide evidence of the review (including country and, if applicable, the regulator’s drug identification number, e.g. the IND if the authority is the FDA) and answer questions G and H.
  1. Drug objections
/ Did the international regulatory authority raise any objections?
No
Yes (Give details below)
If Yes, provide details of any objections.
  1. Drug issue resolution
/ Have all issues raised by the international regulatory authority been satisfied?
No(Give details below)
Yes (Give details below)
  1. Drug details
/ Complete the following information for the drug to be used in the research project.
Approved name:
Trade name (if any):
Manufacturer:
Supplier:
Approved therapeutic indication dosage in Australia:
Believed mode of action:
Dosage regimen:
Mode of excretion:
Known adverse events:
Known contra-indications or warnings:
  1. Pharmacy Department
/ Have arrangements been made for the Pharmacy Department to receive or dispense the drugs involved in this project?
Yes
No(Provide details below)
If No, explain how the drugs will be received and dispensed for the purposes of the research project.
  1. Projects Involving Therapeutic Devices

The following questions apply to both investigational and non-investigational devices. If your proposed research will include more than one type of device, you should duplicate this section for each therapeutic device to be used.
Is this the first use of this therapeutic device in humans?
No
Yes
  1. Registration Status of Devices
/ Is the device included on the Australian Register of Therapeutic Goods (ARTG)?
No(Proceed to question B)
Yes (Give details below)
If Yes, under what name is the device registered?
  1. Use of Device
/ Is the application of the device proposed in this project different from the application(s) of the device included on the ARTG?
No(Proceed to question C)
Yes (Give details below)
If Yes, provide justification, including a summary of the most up-to-date information, to support the unregistered use in this project.
  1. Regulatory authorities for this indication
/ Has the device been registered/licensed/approved for marketing for this indication by an accepted international regulatory authority (other than the Australian Therapeutic Goods Administration)?
No (Proceed to question D)
Yes(Give details below)
If Yes, identify countries and/or regulatory authorities that have registered, licensed or approved the device.
  1. Regulatory authorities for other indications
/ Has the device been registered, licensed or approved for marketing for other indications by an accepted international regulatory authority (other than the Australian Therapeutic Goods Administration)?
No (Proceed to question F)
Yes (Give details below)
If Yes, identify countries and/or regulatory authorities that have registered, licensed or approved the device and give details of the other indication(s) for which the device is registered, licensed or approved.
  1. Device review
/ Has the device been reviewed for investigational or research uses by an international regulatory authority?
No
Yes(Give details below)
If Yes, provide evidence of the review (including country and, if applicable, the regulator’s device identification number).
  1. Device objections
/ Did the international regulatory authority raise any objections?
No
Yes (Give details below)
If Yes, provide details of any objections.
  1. Device issue resolution
/ Have all issues raised by the international regulatory authority been satisfied?
No(Give details below)
Yes (Give details below)
  1. Devicedetails
/ Complete the following information for the device to be used in the research project.
Approved name:
Trade name (if any):
Manufacturer:
Supplier:
Known contra-indications or warnings:

Research Ethics and Integrity | Human Ethics Page 1 of 5
Interventions, Therapies and Trials Module | Version 1.1 | March 2017