Preparing Trial Documents

Once the trial design has been confirmed, the Sponsor-Investigator, or a delegated member of the trial team with the appropriate skills and expertise, can develop the following documents that will be included in the ethics application for the trial.

Protocol

Refer to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) for a checklist of items that should be in the protocol. Your institution may also provide a protocol template. 

Examples

• MCRI: Melbourne Children's clinical trial (drug or device intervention) protocol template
• MCRI: Melbourne Children's clinical trial (non-drug, non-biological, non-device intervention) protocol template

Participant Information and Consent Form (PICF)

For multi-centre studies, it is recommended that you use the standardised PICF templates available from the NHMRC.

For single-centre studies, check with your institution if they have their own template. Otherwise use the appropriate NHMRC PICF template. 

'Patient-facing' materials

Materials for participants, such as diaries, trial advertising materials or Patient Reported Outcomes (PROs) need to be provided to the reviewing HREC with the application.

Non-patient-facing materials

Additional materials are available through the following links for information only; ethics approval not required:

• MCRI: Risk Assessement & Management Plan, for further information see Trial Risk Assessment and Management
• MCRI: Project Data Management Plan Template, for further information see Data Management
• Melbourne Health: Clinical Monitoring Plan, for further information see Monitoring Trial Conduct

Obtain sponsorship approval

The Sponsor-Investigator must obtain approval from their institution to sponsor the trial before ethics approval can be granted. Depending on the process of the host institution, the sponsorship application/review and ethics application/review process may occur in parallel or sequentially, see Sponsorship Risk Assessment and Management.