Research

Forms, templates and guidelines

Initial Application

 

·         New Application Payment Form

·         Human Research Ethics Form (HREA)

·         VSM (Victorian Specific Module)

·         NSW Privacy Form

·         CTN Lodgement Fee Form

·         CTN Template Form

·         Audit or Quality Improvement Application Form

·         Database Registration Form (DRF)

·         Database Access Form (DAF)

·         Austin Health Departmental Sign offs (Pharmacy, PathologyRadiologyNuclear Medicine/PET Centre, Therapeutic Devices & Health Information Services)

 

Governance (SSA) Applications

 

·         Cover Letter and Checklist

·         SSA (Site Specific Assessment Form)

Information Statements and Consent Forms

 

 

·         Person Responsible Oral Information and Consent template, SOP 006 

·         AH logo and barcode

·         Complaints section PICF contact details guidelines – Austin Health Single Site Study

·         Master PICF Complaints Section contact detail guidelines

·         Complaints section contact details – Austin Health Accepting Site

·         Consenting Non-English Speaking Patients into Sponsored Human Health Research

 

·         https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/how-to-make-an-hrec-application-for-clinical-trials -

 

Participant Information and Consent Form (PICF) templates for interventional clinical trial research projects and for genetic clinical trial research.

·         PICF interventional for self

·         PICF interventional for parent & guardian

·         PICF interventional for person responsible

·         PICF Participant Partner Pregnancy

·         PICF genetic for self

·         PICF genetic for parent & guardian

·         PICF genetic for person responsible

 

Participant Information and Consent Forms for other research related to clinical trials

·         PICF non-interventional for self

·         PICF non-interventional for parent and guardian

·         PICF non-interventional for person responsible

·         PICF health and social science for self

·         PICF health and social science for parent and guardian

·         PICF health and social science for person responsible

 

Existing Applications

 

·         Amendment Payment Form

·         HREC Amendment Form

·         Change of Research Personnel Form 

·         Waiver of Consent Request Form – Existing Study

·         HREC progress report: Project Form 

·         HREC progress report: site report

·         Final Report Form

·         Protocol deviation or violation report form

·         Safety Report

·         Online form to notify the TGA of completion of trials of medicines, biologicals and medical devices conducted under the CTN and CTX Schemes.

 

 

Authorised Prescriber

Visit the Therapeutic Goods Administration (TGA) website for the required documentation.