<p>Investigator initiated study eCTN Details Form</p><p>For Initial notifications complete all sections of the form. Changes to existing notification require only section 1 and the affected sections to be completed.</p><p>1. Contact details Epworth principal investigator: Phone Email: number: Epworth study contact: Phone Email: number:</p><p>2. Study details Protocol number: HREC number: (4 to 20 characters) Anticipated start Anticipated end Date: date:</p><p>Study title:</p><p>Study aim:</p><p>Lay summary:</p><p>Therapeutic Number of area: participants:</p><p>FTIH phase I phase II phase III phase IV Study phase: device bioavailability/bioequivalence</p><p>Yes Does the study involve the use of a medicine, the importation of which is </p><p> prohibited under the Customs (Prohibited Imports) Regulations 1956?</p><p>No</p><p>Page 1 of 4 3. Investigational product details</p><p>Medicine details (Duplicate as necessary) Trade name: Registered name: (if applicable) Is this a combination product? Yes No Dose regime:</p><p>Presentation (e.g. 50ml syringe, blister pack, 1ml ampoule) Route of administration:</p><p>Formulation-ingredient details: (including name, formulation, units)</p><p>Indication:</p><p>Dosage and frequency:</p><p>Intended use: comparator standard care therapy</p><p> investigational medicinal product</p><p>Is the medicine manufactured in Yes No Australia? Manufacturer details: (please provide name, address and/or GMP licence number or relevant exemption)</p><p>Placebo details Product name:</p><p>Route of administration:</p><p>Presentation (e.g. 50ml syringe, blister pack, 1ml ampoule)</p><p>Therapeutic or Medical Device details (Duplicate as necessary) Trade name: Registered name: (if applicable)</p><p>Page 2 of 4 Manufacturer details: (Please provide name, address and/or GMP licence number or relevant exemption)</p><p>GMDN search context: Name Code Global Medical Device Nomenclature: Description: </p><p>(details of design, composition, specification, mode of action and application, method of use)</p><p>Intended Purpose: Comparator Standard Care Therapy</p><p>Investigational Medicinal Product Other</p><p>If Other please specify:</p><p>Biological details (Duplicate as necessary) Trade/Product/Code Name:</p><p>Is this a combination product? Yes No</p><p>Presentation (e.g. 5 ml ampoule, 500ml bag)</p><p>Dosage form:</p><p>Route of administration:</p><p>Biologic Ingredient details: (Name, Quantity Unit, Country of Origin)</p><p>Product description:</p><p>For a biological not used in Phase I, is the biological Yes manufactured in Australia? No</p><p>Manufacturer details: (name, address and/or GMP licence number)</p><p>Genetically Modified Organism Description :</p><p>Gene Therapy</p><p>Page 3 of 4 Description :</p><p>Trial in other countries Description :</p><p>4. Site details</p><p>Epworth HealthCare Group sites (Duplicate as necessary) Expected site Epworth site: start date:</p><p>Site address:</p><p>Additional sites (Duplicate as necessary) Expected site Site name: start date:</p><p>Site address:</p><p>Reviewing HREC details: (Name, Code, Officer Contact details) Approving Authority details: (Name, Position, Contact details)</p><p>Page 4 of 4</p>