National and international policies, guidelines and regulations prescribe best practice to ensure research is conducted to the highest governance and ethical standards possible.

State and federal guidelines

The principal documents which govern human research in Australia are listed below:

Policy & guidelines

In addition to being familiar with the national guidelines, all researchers working at the RMH need to comply with the RMH Research Policy and Guidelines for Research Practice. The Research Policy and our guidelines are available to the RMH staff on the policy repository via the intranet.

The RMH guidelines

  • Archiving, retention and disposal of data
  • Data management in research
  • Data storage and security
  • Financial costing & payments 
  • Intellectual property
  • Handling complaints
  • Handling conflicts of interest
  • Monitoring and reporting of safety
  • Publications and authorship
  • Publication of case study reports
  • Research integrity 
  • Use of human tissue

Compliance with our Standards provides public assurance that the rights, safety and well being of research participants are protected and that clinical trial data are credible.

Standard operating procedures

The RMH Office for Research has implemented Standard Operating Procedures (SOPs) to achieve at least minimum good clinical practice standards in clinical trials and other clinical research. 

These SOPs are intended to provide the necessary tools to ensure that all research at the RMH is conducted in accordance with organisational requirements, ICH/GCP guidelines and applicable legislation and regulations.


  • SOP 001 - Documentation of investigational site qualifications, adequacy of resources & training records
  • SOP 002 - Study site master file and essential documents
  • SOP 003 - Communication with HREC, trial sponsor & insurer
  • SOP 004 - Protocol & investigational brochure, content, design, amendments & compliance
  • SOP 005 - Receipt and handling of investigational product
  • SOP 006 - Informed consent procedures and writing PICFs
  • SOP 007 - Case report forms, source documents, record keeping & archiving
  • SOP 008 - Site initiation & close-out
  • SOP 010 - Investigator responsibilities in research
  • SOP 011 - Sponsor responsibilities in investigator initiated studies
  • SOP 012 - Handling & shipping of infectious substances for clinical trials
  • SOP 013 - Creation implementation & revision
  • MH OFR SOP Data sharing & access plan
  • MH OFR SOP Clinical trial monitoring plans & monitoring visits
Contact us
Office for Research: Manager Research Governance
Mon, Tues & Wed
The RMH Parkville
300 Grattan St, Parkville, Victoria