Protocol Design for Prospective Studies and Clinical Trials

Divisions of Radiation Oncology & Cancer Imaging, Cancer Medicine and Cancer Surgery

Protocol Template for Retrospective Data Research Projects

 The following headings cover the requirements of the Peter Mac Ethics Committee. Delete sections that are not applicable and those in purple.  Add version number and date in footer.  Proposed studies should be discussed with a statistician while in the draft stages. It is recommended that the investigator also discuss the proposal with colleagues.  Proposals for all studies which involve patient contact should be presented to the relevant clinical unit/tumour stream for approval prior to submission.

TITLE Version Number and Date Research Number (obtain from Ethics secretariat when ready to submit for review) Principal Investigator & affiliation Associate Investigator(s) & affiliation(s) Supervisor & affiliation (if applicable) Statistician & affiliation

1. PROJECT DESIGN

2. STUDY OBJECTIVES Aims and Hypotheses (primary and secondary)

3. BACKGROUND Consider the following where appropriate to the project: Overview / Context Current practice / current theory Literature review Rationale of current study (why are you doing this study) Significance - contribution to the broader field of study/practice

4. RESEARCH PLAN/METHODOLOGY 4.1 Participants

Selection criteria (Source of patients, identification, inclusion and exclusion criteria, start and end dates of entry)

Participant (de-)identification procedures Suggested wording: Identifiable patient data will be replaced with a code/unique number. The master list of names and matching codes will be stored electronically and password protected by the PI / or kept in locked facilities of the Peter MacCallum Cancer Centre (in the Department of ………).

4.2 Measures Describe primary and secondary endpoints (if applicable). Identify all data that will be collected for use in evaluating project outcomes.

Version No. XX Date: day month year 1 Divisions of Radiation Oncology & Cancer Imaging, Cancer Medicine and Cancer Surgery

4.3 Procedures Consent process(es) (if applicable)

Privacy issues (if applicable): Consider issues such as collecting data from another centre, data being analysed by an external statistician.

Details of data collection, processing and analysis

Record keeping procedures, including storage of data access and destruction Please state: what data is being stored; where it is being stored; how it is secured e.g. password protected; who is responsible for security; how long is the information is being kept; who is responsible for destruction of the information. Examples of wording: • The patient will be kept strictly confidential according to the National Statement on Ethical Conduct in Human Research 2007 and the Australian Code for Responsible Conduct of Research 2007. • Patient research will be accessed only by the named investigators. • Electronic records of research will be retained on password protected computer(s) in databases requiring password access. This will be stored separately from the master list of patient names. • Any hard copies of will be kept in locked facilities of the Peter MacCallum Cancer Centre (in the Department of ………). • Any laptop computer will be password-protected and electronic records stored on it will be coded and in databases requiring password access. Only study investigators will have access to the data. • Patient data will be only be transferred and analysed in a coded form • Individual patients will not be identifiable from the presented or published material. • Patient and research data will be stored on hard disk and CD-ROM for a period of at least 5 years. After 5 years these files will be destroyed by erasure and/or incineration (for CD-ROM) unless further approval for retention is obtained.

5. STATISTICAL CONSIDERATIONS (Include detailed description of statistical analyses to be used; proposed publication or presentation of results)

6. ETHICAL CONSIDERATIONS The study will be conducted according to the NHMRC National Statement on Ethical Conduct in Human Research 2007 (and updates), and the World Medical Association Declaration of Helsinki 2013.

7. REFERENCES

8. APPENDICES (Assessment forms, rating scales, questionnaires, surveys, data collection forms)

Version No. XX Date: day month year 2