Conduct of clinical trials

• Australian Code for the Responsible Conduct of Research
  A framework for ethical, high-quality research that builds public trust
• National Statement on Ethical Conduct in Human Research
  Ethical principles and guidelines for all human research in Australia
• Australian Clinical Trial Handbook
  Practical guidance for designing and conducting clinical trials in Australia
• CT:IQ Beyond the Form Toolkit
  Guidance to help bridge the communication gap between study investigators and trial participants

Reporting of clinical trials

• SPIRIT Statement & Extensions
  Minimum content for trial protocols, including early-phase, factorial, and N-of-1 trials
• CONSORT Statement & Extensions
  Minimum set of recommendations for reporting results of clinical trials, including adaptive, cross-over, and cluster designs
• EQUATOR Network
  A global resource for reporting guidelines across study types
• International Committee of Medical Journal Editors (ICMJE)) Recommendations
  International standards for trial registration, authorship and manuscript preparation
• ACTA & CT:IQ Plain Language (Lay) Summaries
  Tips and tools for writing in plain language
• CT:IQ Beyond the Form Toolkit – reporting research outcomes
  Guidance to help communicate trial findings to trial participants

Further dissemination of results – open access policies

• NHMRC: requires immediate open access to all funded research upon publication
• MRFF: generally aligns with NHMRC’s policies
• ARC: allows open access within 12 months of publication
• NIH (USA): mandates immediate open access for funded research (starting from July 2025)