June 2019 - ERM update
Coordinating Office for Clinical Trial Research
Department of Health and Human Services, Victoria
provided by Coordinating Office for Clinical Trial Research - Department of Health and Human Services, Victoria
Changes to the ERM Site Audit Report form are being released today (31/5/2019). The form has been modified in accordance with the advice of the ERM Working Group. Updates are as follows.
- Addition of questions relating to current protocol:
- Protocol version
- Protocol date
- Addition of statements in the Investigator Self-audit section:
- Training and delegation logs are completed and maintained for this project. Ongoing training for new personnel or for protocol amendments has been completed and documented as required.
- Collection, access, use and/or storage of tissues is carried out in accordance with the protocol and participant consent.
Researchers may be prompted to update their application forms in ERM in order to revise to the newest version. Advice for researchers is published at https://au.forms.ethicalreviewmanager.com and a copy is below. Please provide this guidance to any researchers who have enquiries about updating their forms. Our office (details below) and Infonetica helpdesk (02 9037 8404, helpdesk@infonetica.net) will also be able to advise.
Guidance
You will see a warning message to update your project at the top of the form if your form was included in the update.
We advise that for any un-submitted or un-locked form(s), complete the signatures and submit the form WITHOUT updating the project to avoid losing data and re-signing the form.
This will mean any NEW questions added to the form or new rules will not apply to that version of the form. Please remember to update the project AFTER you have submitted.
Last updated 4 June 2019