Section 4: If your project is a clinical trial investigating a drug or device

4a. Drug and/or Device Clinical Trial Documentation

Submit the following:

• Investigator's brochure (IB) – if conducting a drug, biologicals or device clinical trial, submit one copy of the IB.
• 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
  • 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

For drug trials

For multi-site commercially sponsored clinical trials, visit the Medicines Australia (MA) Clinical Trials website to complete and submit the MA HREC Review Only Medicines Australia Form of Indemnity for Clinical Trials.

For device trials

For multi-site commercially sponsored clinical trials, visit the Medical Technology Association of Australia (MTAA) website to complete and submit MTAA Standard Indemnity Form for HREC review only.

RMH information for indemnity forms

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

4b. Clinical Trial Notification (CTN) lodgement with the Therapeutic Goods Administration (TGA)

For externally sponsored CTN clinical trials

HREC and Approving Authority details for RMH involvement are:

RMH HREC code: EC00243
HREC Contact Officer: Manager, Ethics Office
Contact number: (03) 9342 8530
Contact email: research@mh.org.au
 
Approving Authority: The Royal Melbourne Hospital
Contact Officer: Director, Office for Research
Contact number: (03) 9342 8530
Contact email: research@mh.org.au

Sponsors are asked to provide the RMH Principal Investigator with:

• Confirmation of initial CTN notification/acknowledgment
  (as PDF of lodged CTN from)
• Any updates to the CTN

The RMH Principal Investigator (or delegated study Point of Contact) will forward these essential documents to ethics@mh.org.au or postapproval@mh.org.au on receipt from the sponsor.

For RMH-sponsored CTN clinical trials

The Office for Research will lodge the CTN on behalf of the RMH investigator.