A new suite of teletrial standard operating procedures (SOPs) have been developed to assist sites to conduct teletrials in accordance with Good Clinical Practice (GCP) and any relevant local and national requirements.
The Office for Health and Medical Research (OHMR) developed the SOPs for use in NSW public health organisations involving teletrial sites.
The SOPs help ensure that sites meet the dual requirements of GCP:
- to protect the rights, safety, and wellbeing of participants; and,
- to ensure the reliability of trial data.
Following consultation earlier this year, the SOPs have been updated to reflect the feedback, corporate recommendations from the Clinical Oncology Society of Australia’s (COSA) Australasian Tele-trial Model National Implementation Guide.
There will be an initial six-month review period and all users are encouraged to provide feedback and suggestions to the OHMR for improvement during this review period.
In light of COVID-19, many clinical trials are moving to use teletrials in their recruitment approach; building the support and tools for this capability is welcomed.
Lorraine Chiroiu, CEO, recently spoke to the Sydney Morning Herald, “There has been lots of talk at policy level about involving more rural and remote communities in clinical trials. There's a move towards trying to conduct telehealth consults wherever possible — it will be a great jump start to that," she said.
The voluntary suite of documents is available to anyone working in clinical trials. The suite of SOPs has been released on the OHMR website as part of the NSW Clinical Trials Toolkit.