Australian Clinical Trial Ethics Application

Streamline Your Australian Clinical Trial Ethics Applications

Navigating the complex landscape of clinical trial ethics approval in Australia requires meticulous attention to detail and comprehensive documentation. This Australian Clinical Trial Ethics Application template is designed specifically for researchers, clinical trial sponsors, and healthcare institutions submitting applications to Human Research Ethics Committees (HRECs) while ensuring compliance with TGA (Therapeutic Goods Administration) regulations and the National Statement on Ethical Conduct in Human Research.

Built for Australian Regulatory Standards

This form template guides you through every essential component of a clinical trial ethics submission, from protocol summaries and investigator qualifications to participant information sheets and consent procedures. Whether you're submitting to a public hospital HREC, university ethics committee, or private institutional review board, this template ensures you capture all the required information in a structured, professional format.

The template accommodates various trial phases and study designs, collecting critical details about TGA approval status, clinical trial notifications (CTN), trial registration with ANZCTR (Australian New Zealand Clinical Trials Registry), and WorkCover or insurance arrangements specific to Australian requirements.

Paperform: The Smart Choice for Clinical Research Administration

Paperform transforms complex regulatory submissions into streamlined digital workflows. Unlike static PDFs or basic survey tools, Paperform's document-style editor lets you create professional, on-brand application forms that match your institution's standards while maintaining the rigorous structure required for ethics submissions.

With conditional logic, you can show or hide relevant sections based on trial type, phase, or approval status—ensuring applicants only see questions relevant to their specific study. Collect supporting documentation through secure file uploads, and use calculation fields to automatically validate protocol numbers, ABN details, and trial registration information.

Automate Your Ethics Review Workflow with Stepper

Once your ethics application is submitted through Paperform, you can use Stepper to automate your entire review process. Route applications to the appropriate HREC members based on research category, trigger automated acknowledgment emails with reference numbers, update your research management database, and create approval letters—all without manual data entry.

Stepper workflows can notify relevant stakeholders when applications are received, track review timelines, and ensure compliance with NHMRC guidelines for review timeframes. This automation means your research governance team can focus on substantive ethical review rather than administrative tasks.

Designed for Research Institutions and Clinical Trial Sponsors

This template is ideal for:

• University research offices managing multiple HREC submissions across faculties
• Hospital research governance units coordinating clinical trial applications
• Contract research organizations (CROs) submitting on behalf of sponsors
• Pharmaceutical and biotech companies conducting trials in Australia
• Principal investigators preparing comprehensive ethics applications

With SOC 2 Type II compliance and robust data security, Paperform provides the professional infrastructure needed for sensitive research documentation. The platform's Australian data residency options ensure your ethics applications and participant data remain within appropriate jurisdictions.

Replace cumbersome Word documents and email chains with a modern, efficient digital process that maintains the rigor and professionalism expected in clinical research while dramatically reducing administrative burden.