ERM Update - Version 1.30
This update introduces a few changes across several forms. Please note that updating a project will invalidate any active signatures on it and these will need to be reobtained. This update is not mandatory - if your study is authorised for submission you do not need to update first.
If you encounter any difficulties with the new forms please email ethicsrm@health.govt.nz
HDEC Application Form:
- Local site options for Te Whatu Ora and university localities will be triggered by the applicable response in question B14.3. These will display in Section H5 of the form and are now shared with the locality authorisation form.
- The question on Māori consultation has been renamed Māori engagement.
- An optional ethnicity field for the Coordinating Investigator has been included.
- An option to indicate sponsor authorisation will occur during the locality process has been added for studies sponsored by Te Whatu Ora
- In the screening section observational studies involving tissue that do not involve identifiable health information will now correctly be allocated to the expedited pathway
Protocol deviation/violation form:
- An option to indicate the deviation/violation concerned urgent safety measures has been included.
HDEC Amendment Form
- An introduction has been included with guidance on substantial and non-substantial submissions
Locality Authorisation Form
- The 'additional locality' form has been renamed 'Locality Authorisation'. A new field has been included for the site name and an optional field for contact details of the person authorising the study for the locality.
- The local sponsor/locality question from the main application is now shared with all locality authorisation forms and may be updated when new localities are added.
- A document upload button has been included to upload scans of paper-based authorisations.
SCOTT / GTAC Form
- An optional signature authorisation question has been added.
Change of Details [SCOTT]
- A new change of details form has been created to amend the name of the coordinating investigator and study title that displays on letters. Please note changing the coordinating investigator requires SCOTT approval if the new CI is not an already approved investigator.