For Initial Notifications Complete All Sections of the Form

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?

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)

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

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)