HeSANDA consultations with clinical trials researchers – governance and other IT requirements

Virtual consultation workshops

As part of its National Data Assets program, ARDC seeks to facilitate and catalyse the development of a Health Studies Australian National Data Asset (the HeSANDA program).

The long term goal of HeSANDA is to build the national infrastructure required to support the sharing and reuse of health research data in a way that would bring value to the research community, increase the impact of research, and provide benefits for the health of Australia’s population.

ARDC will take an incremental approach to HeSANDA. The initial focus is on sharing and reusing data from publicly-funded clinical trials research conducted in the academic sector. As the first step in this journey, ARDC seeks to establish consensus amongst clinical trials researchers interested or involved in data sharing about how they would use a national data asset to support and improve their research activities.

ARDC invites interested parties to participate in a series of consultation workshops to help establish the research uses, data requirements, and feasibility of a national data asset created from clinical trials research data. These topics will be addressed via a series of consultation workshops on the basis of four themes:

• Theme A – Research purpose
• Theme B – Data content & quality requirements
• Theme C – Existing data standards & practices
• Theme D – Governance, IT, & other considerations

The priority for the workshops shall be to address Themes A, B, and C in order to identify the research purpose, contents, and data standards of the data asset. The Theme D workshop shall provide the initial opportunity to discuss the range of other topics important for the successful implementation of a data asset (e.g. governance, ethics, etc), however, the topics identified in Theme D shall be explored in a separate consultation series (to be announced soon) to consider these issues and requirements in greater depth.

The outcomes of these consultations will be documented and used to inform the criteria for funding of infrastructure to support the national data asset.

How will it work?

A series of open workshops will be held every 3 weeks to address the themes as follows:

• 11 Aug – Research purpose
• 1 Sep – Data content & quality requirements
• 22 Sep – Existing data standards & practices
• 13 Oct – Governance, IT, & other requirements

Each theme will be supported by:

• Background documentation & structured feedback form
• A moderated workshop with Q&A and breakout sessions

Repeat workshops may be organised subject to demand. Interested parties who are unable to attend the workshops may be allowed to contribute to the consultations by providing written submissions and feedback via the workshop forms. All interested parties should register for this event regardless of whether they can attend the workshops.

Who is this for?

For this first consultation series, ARDC seeks the expertise and experience of clinical trials researchers in Australia who are involved in data sharing (as either a data producer and/or user) to establish their data requirements, needs, and specifications as outlined above.

Please note, this first consultation series will have a narrow focus on the research purpose and contents of the data asset. A separate consultation series will be announced soon that will focus on the implementation and operational requirements for data sharing (governance, ethics, security, etc) and will be aimed at health researchers, institutions, organisations, and policy makers involved in clinical trials research more broadly.

How do I find out more information?

Visit HeSANDA or contact ARDC

NOTE:

This is an open event and any interested party may register to attend. However:

• ARDC reserves the right to limit attendance as appropriate, subject to resources and demand.
• ARDC was established to support the Australian research sector. In the case of oversubscription to this event, priority will be given to those living in Australia and/or working for Australian health research organisations.

Event details are subject to change at ARDC’s discretion.