Observational Research Required Documentchecklist

Observational Research Required DocumentChecklist

All items must be made available to Waikato DHB Research Office prior to commencing any research involving patients, patient information, staff or sites of Waikato DHB. Documents can be made available via HDEC online application system (where appropriate) by authorising Waikato DHB to view your project file.

WaikatoDHB Registration# RD______

Documentation / Comments / Date
Project Registration / Register your research: You will be given a registration (RD) number.
Project Proposal/Protocol / Email to
Waikato DHB Approval of Research Form / Form will be emailed to researcher following registration. Emails from approvers are acceptable as electronic sign-off or return signed form. Usually Director, Clinical Director and Executive Director approval may be required depending on your study.
Waikato DHB Clinical Support Services Sign-off (if any)e.g. Clinical Records, Pharmacy, Labs, Radiology, / This is included in the Approval of Research form – see notes above.
Note: any study that includes the administration of medicines should use Interventional Research Document Checklist.
Ethics Application Form (if required)
HDEC Locality Approval / Complete form, located at:
For HDEC: must be selected as an authoriser in the online HDEC system. For other Institutional Ethics Committees: the final approved version is required.
Finance / Indicate the cost to the DHB of undertaking the research (such as researcher time, consumables.)
Procurement / For any study involving equipment or consumables not already approved by Waikato DHB, log a portal request #521. Include copy of approval email with Approval of Research form. Guidance available from Research Office.
Participant Information Sheetand Consent form (if any) / Final Waikato DHB version required.
Participant questionnaire or interview schedules (if any) / Final Waikato DHB version required.
Participant advertisements/ letters of invitation (if any) / Final Waikato DHB version required.
Funding Contract (if any) / Required only if signed by Waikato DHB. The Director Quality & Patient Safety must sign all research contracts on behalf of Waikato DHB. Send to
Evidence of cultural consultation (if required) / Go to website and complete required form(s). Any queries, please contact research office,
Waikato DHB Access to Information Declaration / Required for any non-Waikato DHB staff accessing Waikato DHB patients, patient information or premises.
Letter of approval from researcher’s Institution / Letter of approval and acceptability where PI is a student researcher not employed by Waikato DHB and is accessing Waikato DHB patient information or premises.

Any queries should be directed to Waikato DHB Research Office by email