Concerned about your own or
someone else’s drug use?


New evidence
based knowledge

Clinical Research Resources

Clinical research: design, development and reporting

Below are some links to important guidelines for conducting clinical research in Australia. Another useful resource will be the Human Research Ethics Committee (HREC) you plan to submit your project to for review. We recommend contacting the HREC (or associated research office) early in the development of your clinical research protocol. They will be able to provide further information on the submission process, as well as local policies and requirements. Often, additional resources pertaining to clinical trials pharmacies, radiation exposure requirements, etc., will also be available from the office to which you are submitting your research project for review.

Developing a Participant Information Sheet and Consent Form

Standardised Participant Information and Consent Forms

If you are developing a clinical research project, you will need to have a Participant Information Sheet and Consent Form. In Australia, The National Health and Medical Research Council (NHMRC) has developed basic templates that can provide an initial framework for researchers when writing the patient information sheet and consent form. For definitions of Informed Consent, refer to the ICH-GCP guidelines or The National Statement.


Developing a Research Protocol

The SPIRIT Statement

When developing your clinical trial protocol in line with The National Statement and ICH-GCP, the SPIRIT statement can be used as a guide for what to include. SPIRIT stands for Standard Protocol Items: Recommendations for Interventional Trials. The SPIRIT statement provides recommendations for a minimum set of scientific, ethical and administrative elements that should be addressed in a clinical trial protocol.


The Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network

Guidance for writing a protocol for non-clinical trial research (e.g. a qualitative or case-control study) as well as additional links to reporting guidelines.


Critical Appraisal Toolkits

Critical appraisal skills enable you to systematically assess the trustworthiness, relevance and results of published papers.

The Joanna Briggs Institute

The Joanna Briggs Institute’s critical appraisal tools assist in assessing the trustworthiness, relevance and results of published papers.


UofA JBI Logo

The Critical Appraisal Skills Program

The Critical Appraisals Skills Programme (CASP) has 25 years of significant and unrivalled expertise in the delivery of training to healthcare professionals.


CASP – Critical Appraisal Skills Programme Logo

Reporting Study Results

When reporting Clinical Research (i.e. preparing a manuscript for a peer-reviewed journal), there are specific guidelines to follow when analysing and writing up your results. Some journals will explicitly state which guidelines authors should follow. Well recognised reporting guidelines for Randomised Controlled Trials (RCTs), Observational Studies, and Systematic Reviews / Meta-analyses are listed below.



The CONSORT (CONsolidated Standard of Reporting Trials) guideline for RCTs was developed by the CONSORT group and contains a checklist and flow-diagram for authors and reviewers.


STROBE The STrengthening the Reporting of OBservational Studies in Epidemiology (STROBE) Statement is a guideline for reporting cohort, case-control, and cross-sectional studies. A checklist and flow-diagram is available for authors and reviewers.


PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) is a minimum set of items for reporting systematic reviews or meta-analyses. A check-list and flow diagram is available for authors and reviewers.

Trial Registries

Clinical Trials should be registered, and without registration peer-reviewed journals can refuse to publish the study results. For example, the International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial. Studies are required to be publicly registered prior to enrolling any participants. In Australia, trials can be registered with the Australian and New Zealand Clinical Trials Registry, the United States National Library of Medicine, or both.  

Australian and New Zealand Clinical Trials Registry

The Australian and New Zealand Clinical Trials Registry (ANZCTR) is an online registry of research being undertaken in Australia, New Zealand and elsewhere. It is a free trial registry recognised by the World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) as a primary registry (see the WHO ICTRP here: http://apps.who.int/trialsearch/)



The US National Library of Medicine ClinicalTrials.gov Trial Registry An online registry and global database of clinical trials. It is a free trial registry recognised by the World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) as a primary registry (see the WHO ICTRP here: http://apps.who.int/trialsearch/)


Research databases

The TRIP Database is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice and/or care.


Trip database - a different way to find evidence - Students 4 Best Evidence

The Cochrane Libraryis a collection of databases that contain different types of high-quality, independent evidence to inform healthcare decision-making. This includes: The Cochrane Library of Systematic Reviews which is the leading resource for systematic reviews in health care; The Cochrane Central Register of Controlled Trials (CENTRAL); and Cochrane Clinical Answers (CCAs).


Cochrane Library logo


The Open Access Button provides access to free, legal research articles delivered instantly or automatically requested from authors.


The PubMed database contains more than 32 million citations and abstracts of biomedical literature. It does not include full text journal articles; however, links to the full text are often present when available from other sources, such as the OpenAccess Button (above)


pubmed logo

Other research resources

The Australian Clinical Trials Alliance creates and hosts a number of varied clinical research resources, for their members and the public. These range from consumer toolkits to statistics advice, trial design guidance to advice on research during the time of COVID-19.


ACTA – Australian Clinical Trials Alliance

The James Lind Library uses material from history to illustrate the principles underlying fair tests of treatments and their development and application over time, and how these relate to the interests of today’s patients. It is an interesting resource which illustrates the evolution of principles of fair tests of treatments, and the application of these principles, in practice.


Consumer involvement and engagement

If you are interested in taking part in a clinical trial

Australian Clinical Trials

The Australian Government provides information for people who are considering or who have been invited to take part as a participant in a clinical trial. Information and resources are provided to consumers as well as health care providers, researchers and industry.


The National Institutes of Health (US) Clinical Trials and You

The NIH Clinical Trials and You website is a resource for people who want to learn more about clinical trials. The website covers most of the frequently asked questions, breaking down how the research process works, who the key stakeholders are and what are the kinds of clinical research.


National Institutes of Health (NIH) - Turning Discovery into Health


The Australian Clinical Trials Alliance have developed a Consumer Information Pack which describes what it means to be involved in health research and the many ways you can get involved.


Consumer Involvement and Engagement Toolkit for Researchers and Organisations

This Toolkit is a joint initiative between the Australian Clinical Trials Alliance (ACTA) and Clinical Trials: Impact & Quality (CT:IQ). It is an interactive map that provides information on how researchers and research organisations can involve and engage consumers to help shape research throughout its lifecycle. The primary focus of the Toolkit is clinical trials, although much of the content is relevant to other types of health research.


Australian Clinical Trials Alliance