22.10.21 – ERM Forms Update

This update introduces a new form and a few miscellaneous bug fixes across other forms.

Please note that updating a form to version 1.24 will invalidate any active signatures on it. These will need to be requested again before submission.

 New sub-form – Additional Signature/Contact Request

• This form has been created for researchers to add additional signature requests and contacts which do not require HDEC approval to a study (e.g. additional investigators, Sponsor representatives or localities).
• If miscellaneous documents are required to be submitted to HDEC (e.g. for regulatory reasons) they can be included in this form.
• Please do not use this form to submit documents that were missed off a main application as they cannot be transferred across. Please contact the HDEC Secretariat if an application is submitted with missing documentation.
• This form can be used for both HDEC and SCOTT submissions. 

Sub-forms

• All sub-forms should now automatically be assigned to the parent committee of the main application by the system. This was an issue that was affecting some HDEC final reports.

HDEC Application Form

• Additional fixes and tweaks to the screening form. If you still encounter issues with two or zero pathways displaying please email: ethicsrm@health.govt.nz

 HDEC Amendment Form:

• Selecting the submission of non-standard conditions will now correctly display a document upload button.

 SCOTT Post-Approval Form

• The SCOTT annual progress form has been corrected to ask for total global numbers of participants only, not numbers for each site in the study.

Additional updates for the HDEC and SCOTT forms

HDEC Form:

More fixes to the screening section. If you still get no or more than one pathway please email: ethicsrm@health.govt.nz

The single line text fields for questions C2, D5, D6.1, D12, D13.2 and D15 have been replaced with multiline text boxes without character limits. Please note if you have answered these questions and not submitted your form your answer will likely disappear. It is recommended to export your application as a PDF before updating so you can copy and paste the answer in again.

HDEC Progress Report Form:

A text box has been added to question PR14 (insubstantial changes/protocol deviations).

HDEC Notification of Conclusion Form:

It is now possible to submit the form without uploading any supporting documents.

SCOTT Form:

Additional options for study categories have been added including not applicable. These are no longer mandatory to answer in order to submit the form.

SCOTT Post-Approval Form:

Miscellaneous / insubstantial documents can now be uploaded.