Reporting templates

Page contents: Amendments to research projects | Adverse events | Annual reports/final reports

Amendments to research projects

Researchers must inform the Committee of any modifications to the approved protocol. Generally, the Committee only notes minor modifications, while more significant modifications may require further consideration prior to approval. In most cases, amendments are presented for consideration at the next scheduled HREC meeting. Provisional approval of protocol amendments may be provided between meetings by the Chair or his/her nominee, but must be ratified by the full HREC at its next meeting. Researchers should provide sufficient detail to allow the Committee to understand the background and rationale for the amendment.

Researchers wishing to amend an approved project should download the Amendment Request Form and forward the completed form, together with supporting documents, to the Executive Officer, DH HREC. Amendments may be submitted in hard copy or by email. The deadline for submission of amendments is two weeks prior to the scheduled meeting of the HREC as per the listed meeting and submission dates.

Amendment Request Form - February 2010 (34kb, MS Word)

Adverse events

All adverse or unforeseen events must be reported to all HRECs that approved the project. To report these events to the DH HREC, researchers should download the Adverse Event Report Form and forward the completed form to the Executive Officer, DH HREC as early as possible following the event. Reports may be submitted electronically.

Adverse Event Report Form - February 2010 (46kb, MS Word)

Annual reports/final reports

Researchers must submit progress reports at regular intervals for the duration of the project. The DH HREC requires annual reports. If the project has ended within any given twelve-month period, the final annual report should state the outcome(s) of the project. Researchers should download the Annual Report Form and forward the completed form to the Executive Officer, DH HREC. Reports may be submitted electronically.

Annual Report Form (2006 Version) (54kb, MS Word)

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