PROTOCOL SUGGESTED FRONT PAGE – ALL RESEARCH STUDIES

FULL STUDY TITLE

SHORT TITLE OR ACRONYM

LAY DESCRIPTION OF THE PROJECT (2-3 LINES ONLY)

WORDING TO STATE STUDY WILL BE CONDUCTED IN COMPLIANCE RELEVANT LEGISLATION AND GUIDANCE DOCUMENTS

STUDY INVESTIGATOR(S)

Name / Phone / Email / Institution / Study Role (e.g. Principal Investigator)

SUGGESTED RESEARCH PROTOCOL TEMPLATE HEADINGS(delete those not applicable)

  1. INTRODUCTION
  2. BACKGROUND
  3. AIM(S) OF STUDY
  4. Primary Aim(s)
  5. Secondary Aim(s)
  6. OBJECTIVE(S)
  7. Primary Objective(s)
  8. Secondary Objective(s)
  9. HYPOTHESI(E)S
  10. Primary Hypothesi(e)s
  11. Secondary Hypothesi(e)s
  12. STUDY DESIGN
  13. STUDY SETTING/LOCATION(S)
  14. STUDY DURATION
  15. STUDY POPULATION
  16. Recruitment Process
  17. Inclusion criteria
  18. Exclusion criteria
  19. Potential for Risk, burdens and benefits
  20. STUDY OUTCOMES
  21. Primary Outcome
  22. Secondary Outcome(s)
  23. STUDY PROCEDURES
  24. Recruitment and consent of participants
  25. Withdrawal of participants from a study

11.2.1 Participant withdrawal from study procedures

11.2.2 Participant withdrawal from a study

11.3Randomisation

11.4Measurement tools used

11.5Study involvement by participants

11.6Data management

11.7Safety considerations/Patient safety

11.8Data monitoring

  1. SAMPLE SIZE AND DATA ANALYSIS
  2. Sample size and statistical power
  3. Data analysis plan
  4. ETHICAL CONSIDERATIONS
  5. DISSEMINATION OF RESULTS AND PUBLICATIONS
  6. OUTCOMES AND SIGNIFICANCE
  7. GLOSSARY OF ABBREVIATIONS
  8. REFERENCES

Recommended protocol templates:

TownsvilleHospital and Health Service clinical trial protocol.

Based on QH GCP SOP 4: Protocol and Investigational Brochure Content, Design, Amendments & Compliance Prepared by the Research Ethics and Governance Unit May 2010 1. Based on, and with permission of the Victorian Managed Insurance Authority – VMIA GCP SOPS: (Templates: General templates: Study protocol template)

SPIRIT

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol:

Mater Research – UQ

This research protocol guidance document aims to offer researchers a generic guide suitable for a broad range of research studies: (Mater guidelines: Guide to writing a research protocol)