Maintaining and reporting of adverse events and safety information in research will ensure that RMH complies with the NHMRC

Melbourne Health has implemented guidelines for monitoring & reporting safety which comply with the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016), NHMRC National Statement on Ethical Conduct in Human Research (2007), the Australian Therapeutic Goods Administration, and the Victorian Managed Insurance Authority, maintaining and reporting of adverse events and safety information in clinical research.

It is essential that all Principal Investigators are familiar with and comply with the requirements of the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).

Reporting time frames

Reporting time frames are defined in the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).

Researchers should also comply with MH policy and procedures for reporting adverse events including:

  • MH18 Research Policy
  • MH19 Risk Management Policy
  • MH19.02 Incident Reporting
  • MH14.08 Adverse Drug Documentation and Reporting
  • PCY08.03 Assessing and Processing Reported Adverse Drug Events

NHMRC safety reporting flowcharts

Instructions for reporting adverse events

MH researchers and clinicians reporting to Melbourne Health

What to report

Investigators should report the following safety information only for participants at MH sites to the Office for Research:

  1. All Significant Safety Issues (SSIs) reported as Urgent Safety Measures (USMs), as amendments or as a temporary halt/early termination of a trial; and
  2. SUSARs/USADEs that are considered possibly related, probably related or definitely related to study conduct.

How to report SSIs and SUSARs/USADEs to MH

  1. Click here to open the email template: HrecCorrespondence@mh.org.au
  2. Enter all information requested in the email template.
  3. Complete and attach the DHHS Safety Report form signed by the principal investigator.
  4. For SUSARs/USADEs ONLY - Also include the patient details and provide any supporting documents in the email. This will enable the Office for Research to report the events accurately to the insurers, VMIA.
  5. Ensure that you name the subject of the email so that it includes the project number, the type of document and the date it was sent (such as 2018.001 SUSAR 1 Jan 2018).

Acknowledgement

  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Office for Research staff in due course.
Investigator reporting to the sponsor

What to Report:

Investigators should report the following safety information to the Sponsor as per the Sponsor's protocols:

  1. SAEs as defined in the protocol;
  2. Any occurrences of congenital abnormality/birth defect arising from any pregnancy of a participant (or partner);
  3. USMs instigated by the site, and;
  4. Safety critical events as defined in the protocol.

Acknowledgement

  • You will receive an automatic email reply confirming receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Office for Research staff in due course.
Sponsor reporting to the MH HREC

What to Report:

Sponsors should report the following trial safety information to the HREC:

  1. Significant Safety Issues (SSIs) reported as Urgent safety Measures (USMs), as amendments or as a temporary halt/early termination of a trial;
  2. Annual Safety Reports (refer to Annual Safety Report section below) , and:
  3. Investigator Brochure updates and interim addenda (submitted as an amendment).

How to report SSIs to the MH HREC:

  1. All SSIs, annual safety reports, IB updates and interim agenda must be submitted by the Sponsor or delegate.
  2. Click here to open the email template: HrecCorrespondence@mh.org.au
  3. CC the CPI of the trial.
  4. Enter all information requested in the email template.
  5. Attach the DHHS Safety Report form signed by the principal investigator.
  6. Ensure that you name the subject of the email so that it includes the project number, the type of document and the date it was sent (such as 2018.001 SUSAR 1 Jan 2018).

Acknowledgement

  • You will receive an automatic email reply confirming receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Office for Research staff in due course.
Sponsor reporting to site investigator

What to Report:

Sponsors should report the following trial safety information to the Site Investigator:

  1. Significant Safety Issues (SSIs) reported as Urgent safety Measures (USMs), as amendments or as a temporary halt/early termination of a trial;
  2. All SSIs that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial;
  3. Investigator Brochure updates and interim addenda, and;
  4. SUSAR/line listings (only if required by the sponsor’s global SOPs).

Note: MH investigators are not required to review safety report from other sites.

Acknowledgement

  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Office for Research staff in due course.
Sponsor* reporting to the Therapeutic Goods Administration (TGA)

*Important Note: Where MH is the trial sponsor, the MH Principal Investigator is responsible for reporting to the TGA

What to Report:

  1. All SUSARs occurring in Australian participants,
  2. All SSIs that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.

Acknowledgement

  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Office for Research staff in due course.
Annual safety report

Melbourne Health has adopted the NHMRC's Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (2016) guideline.

This updated version has removed the requirement to submit individual reports of AEs, SAEs, external SUSARs/USADEs and six monthly line listings to institutions. Please refer to the information relating to line listings in the summary on page 3 and 'Note 1' on page 7.

Melbourne Health requires the sponsor to provide HRECs with an annual safety report.

How to submit an annual safety report

  1. Click here to open the email template: HrecCorrespondence@mh.org.au

  2. Enter all information requested in the email template

  3. Attach the Annual Safety Report Form
  4. Name the file and the subject of the email so that it includes:
  • the project number and/or HREC Reference number,
  • the type of document; and
  • the date it was sent

Example: 2017.999 HREC/17/MH/999 Safety Report 1 Jan 2017

Acknowledgement

  • You will receive an automatic email reply confirming receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Office for Research staff in due course.