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

Protocol Template for Retrospective Studies

  • The following headings cover the requirements of thePeter 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 astatistician 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.
  • For further suggestions on protocol design see (R:\RESEARCH\Protocol & Grant Writing\How to write a Protocol.doc) or contact Suzie Roache.

TITLE

Version Number and Date

Research Number (obtain from Ethics secretariat)

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

Overview /Context

Current practice/theory

Literature review

Rationale of current study

Significance - contribution to the broader field of study

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 ………).

4.2Measures

Describe primary and secondary endpoints. Identify all data that will be collected for use in evaluating project outcomes.

4.3Procedures

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 dataaccess and destruction

Examples of wording:

•The patient data 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 data will be accessed only by the named investigators.

•Electronic records of research data will be retained on password protected computer(s) in databases requiring password access. This data will be stored separately from the master list of patient names.

•Any hard copies of data 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

(Statistical analyses; 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 and the World Medical Association Declaration of Helsinki 2008.

7. REFERENCES

  1. APPENDICES

(Assessment forms, rating scales, questionnaires, surveys, data collection forms)

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