Resources

Protocol development

• Melbourne Health protocol template
• SPIRIT 2013 Statement: This provides recommendations for a minimum set of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol.
• Consort Statement: Provides standards for reporting trials that should be considered in development of trial protocols.
• MH statistical review process and MH statistical review proforma
• Peer review process and Peer Review Proforma

Consumer Engagement

Reasons for involvement of consumers in research include:

1. It makes for better research
2. There is a strong moral case based on social justice for doing so
3. It is increasingly being demanded by funding bodies
4. it is a requirement of the National Clinical Trials Governance Framework

• RMH Consumer, Carer & Community Participation
• VCCC Consumer engagement toolkit
• Australian Clinical Trials Alliance Consumer Involvement & Engagement Toolkit
• NHMRC Statement on consumer and community involvement in health and medical research

Statistical support

Statistical input:

• should be appropriate to the study.
• be sought during the design stage of the project and prior to the submission of the project.
• will assist with development of the research question(s), selection of study design, sample size calculation and statistical analysis plan.

For RMH researchers, the RMH has made arrangements for the MISCH (Methods and Implementation Support for Clinical and Health), at the University of Melbourne, to provide statistical support.

MISCH can provide collaborative Biostatistics and Health Economics research support, research and grant development, analysis and publication. For more information or to contact MISCH visit the website.

Literature Review support

Comprehensive / systematic literature review support can be provided by:

• Health Sciences Library

Training at the RMH

• Good Clinical Practice training offered at RMH is listed on the Research Education and Training web page.