VMIA has consulted with a number of stakeholders and has received feedback on the revised VMIA Clinical Trials – Insurance and Risk Management Guidelines (Guidelines) published on 13 July 2012.
The updated Guidelines, version 2, September 2012, are now available.
The main updates include improved clarity regarding:
- The VMIA Minimum Insurance Requirements. These have been streamlined and the process requirements in relation to the certificate of currency submission have been simplified.
- SUSAR notifications. VMIA only requires the same form as submitted to the HREC committee. The form must be emailed to firstname.lastname@example.org at the time of notification of the SUSAR to the HREC.
- Mandatory requirements. It is no longer a mandatory requirement to provide the Clinical Trials Advice Form to VMIA and there is no retrospective application of this form.
- Use of the Participant Information & Consent Form (PICF) by VMIA clients. In respect to key point 10 of the 'Quick Reference Guide', reference to use of the PICF has been changed from 'must use' to 'should use'.
VMIA is committed to exploring further opportunities for ongoing improvement and is in the process of engaging with relevant industry peak bodies and other stakeholders.
If you have any queries please email email@example.com
Clinical Trials Insurance and Risk Management Guidelines [PDF, 703KB] [PDF, 202 KB] - September 2012
Clinical Trials Certificate of Currency Form [PDF, 60KB] - September 2012