Template

Decentralised Trials Research Governance Review Checklist

This Checklist is designed to support Research Governance Officers in reviewing submissions for governance authorisation of Decentralised or Teletrial studies by outlining the additional steps required. It may also assist researchers to prepare their submissions.

Key Takeaways

  • Designed to promote consistency in governance review processes for research studies that include one or more Decentralised Trial or Teletrial sites
  • Can be used by researchers and governance staff as a guide for submissions that require research governance review of clinical trials being conducted under the Decentralised Trials or Teletrial model
  • Indicates tasks relevant to either the Primary Site (PS) and/or Satellite Site (SS)

Who is this for?

The  Checklist is for anyone applying for governance authorisation for a Decentralised Trial or Teletrial. The Checklist should be used in conjunction with standard governance review checklists (see links at Related Resources below). It has been developed by Research Governance Officers for use at the following sites:

Central Coast Local Health District

Hunter New England Local Health District

Illawarra Local Health District

Murrumbidgee Local Health District

Mid North Coast Local Health District

Nepean Blue Mountains Local Health District

Northern New South Wales Local Health District

Northern Sydney Local Health District

South Western Sydney Local Health District

St Vincent’s Hospital

Sydney Local Health District: Concord Repatriation General Hospital Research Office

Sydney Local Health District: Royal Prince Alfred (RPA) RPA

The Sydney Children’s Hospitals Network

The Westmead Institute for Medical Research

Western Sydney Local Health District