Section 5: For clinical trials investigating a drug and/or device

5a. Drug and/or Device Clinical Trial Documentation

For all trials submit:

• Insurance certificate: For commercially sponsored clinical trials, submit a copy of the sponsor's certificate of insurance. This should comply with the requirements for clinical trials insurance as outlined in the VMIA Guidelines for Clinical Trials for Victorian Public Hospitals.
• Investigator’s Brochure (IB): IB or product information for investigator initiated trials that do not have and IB.
• GCP training certificates: Evidence of GCP training for all members of the RMH trial team.
• Data Safety Monitoring Board (DSMB) or other safety monitoring processes: For randomised controlled trials, the protocol or ethics application should enable the HREC to determine the following:
  • If a DSMB is to be convened, what its main role and function will be and provide (or confirm if it is provided in the protocol or other documents):
    • The DSMB is constituted and functions in line with the NHMRC Data Safety Monitoring Boards (DSMBs) guidance
    • Provide the Terms of reference
    • List of DSMB members, role and affiliations
  • If a DSMB is not to be convened, confirm the alternative mechanism for monitoring trial safety and whether this is justified given the nature of the trial (refer to Section 10 of NHMRC Data Safety Monitoring Boards (DSMBs) guidance)
  • That appropriate (risk‑based) processes for monitoring trial safety and data integrity are planned.

Note: if the DSMB has not been established by the submission of the HREC application, confirm this in the cover letter and provide the information in the research

For drug trials

Visit the Medicines Australia (MA) Clinical Trials website to download, complete and submit all the following:

• MA Clinical Trial Research Agreement (CTRA): A draft copy of the applicable MA CTRA; and
• Indemnity forms: For commercially sponsored clinical trials, a copy of the following documents (as applicable):
  • MA Standard Medicines Australia Form of Indemnity for Clinical Trials;
  • MA HREC Review Only Medicines Australia Form of Indemnity for Clinical Trials

Find out more about financial management and information regarding invoicing and payment clauses to be included in the clinical trial research agreement.

For device trials

Visit the Medical Technology Association of Australia (MTAA) website to download, complete and submit the following documents:

• MTAA Standard Clinical Investigation Research – A draft copy of the MTAA Standard Clinical Investigation Research Agreement (CIRA); and
• Indemnity forms – For commercially sponsored clinical trials, a copy of the following documents (as applicable):
  • MTAA Standard Indemnity Form for a clinical investigation
  • MTAA Standard Indemnity Form for HREC review only

Find out more about financial information regarding invoicing and payment clauses to be included in the agreement.

RMH information for agreements & indemnity forms

Clinical Trial/Investigator Research Agreements

For all agreements where Royal Melbourne Hospital is a party, complete the “Institution” details as per below:

Indemnity

For all indemnities given by sponsors to RMH, please complete the “To” or (“the Indemnified Party”) section on page one as follows:

5b. Site selection dates for externally sponsored clinical trials

For commercially sponsored clinical trials, enclose a copy of the correspondence from the sponsor confirming selection of RMH as a participating site in the trial – include the corresponding Project number.

5c. Clinical Trial Notification (CTN) information

For externally sponsored CTN clinical trials

External sponsors may be commercial, a collaborative group or another hospital.

On receiving the HREC approval from the reviewing HREC, external sponsors can lodge the CTN directly with the Therapeutic Goods Administration (TGA), online. Sponsors are asked to provide the RMH Principal Investigator with a copy of the TGA's confirmation/acknowledgement of the CTN together with a PDF copy of the lodged CTN application to forward to ethics@mh.org.au as soon as this is available.

For RMH sponsored CTN clinical trials

This applies where investigator-initiated trials have no external sponsor and it has been agreed that the RMH will sponsor the trial.

On receiving Site Specific approval letter from the RMH, researchers need to make an appointment with the Research Support Officer to lodge the CTN application online together.

The fees associated with the CTN submission will be set against the applicable research cost centre.

Direct any questions about the CTN submission scheme to the Research Support Officer.