Investigator initiated study eCTN Details Form

For Initial notifications complete all sections of the form. Changes to existing notification require only section 1 and the affected sections to be completed.

1. Contact details Epworth principal investigator: Phone Email: number: Epworth study contact: Phone Email: number:

2. Study details Protocol number: HREC number: (4 to 20 characters) Anticipated start Anticipated end Date: date:

Study title:

Study aim:

Lay summary:

Therapeutic Number of area: participants:

FTIH phase I phase II phase III phase IV Study phase: device bioavailability/bioequivalence

Yes Does the study involve the use of a medicine, the importation of which is

prohibited under the Customs (Prohibited Imports) Regulations 1956?

No

Page 1 of 4 3. Investigational product details

Medicine details (Duplicate as necessary) Trade name: Registered name: (if applicable) Is this a combination product? Yes No Dose regime:

Presentation (e.g. 50ml syringe, blister pack, 1ml ampoule) Route of administration:

Formulation-ingredient details: (including name, formulation, units)

Indication:

Dosage and frequency:

Intended use: comparator standard care therapy

investigational medicinal product

Is the medicine manufactured in Yes No Australia? Manufacturer details: (please provide name, address and/or GMP licence number or relevant exemption)

Placebo details Product name:

Route of administration:

Presentation (e.g. 50ml syringe, blister pack, 1ml ampoule)

Therapeutic or Medical Device details (Duplicate as necessary) Trade name: Registered name: (if applicable)

Page 2 of 4 Manufacturer details: (Please provide name, address and/or GMP licence number or relevant exemption)

GMDN search context: Name Code Global Medical Device Nomenclature: Description:

(details of design, composition, specification, mode of action and application, method of use)

Intended Purpose: Comparator Standard Care Therapy

Investigational Medicinal Product Other

If Other please specify:

Biological details (Duplicate as necessary) Trade/Product/Code Name:

Is this a combination product? Yes No

Presentation (e.g. 5 ml ampoule, 500ml bag)

Dosage form:

Route of administration:

Biologic Ingredient details: (Name, Quantity Unit, Country of Origin)

Product description:

For a biological not used in Phase I, is the biological Yes manufactured in Australia? No

Manufacturer details: (name, address and/or GMP licence number)

Genetically Modified Organism Description :

Gene Therapy

Page 3 of 4 Description :

Trial in other countries Description :

4. Site details

Epworth HealthCare Group sites (Duplicate as necessary) Expected site Epworth site: start date:

Site address:

Additional sites (Duplicate as necessary) Expected site Site name: start date:

Site address:

Reviewing HREC details: (Name, Code, Officer Contact details) Approving Authority details: (Name, Position, Contact details)

Page 4 of 4