A8 – Improving Investigational Site Operations

During this session we will explore improving investigational site operations via (1) Site metrics and their role in promoting your site (2) An update on the National PICF project (including pilot data) and (3) Risk based monitoring for investigator initiated clinical trials. Go to the ARCS website for full details of these topics.

Site metrics and their role in promoting your site

Over the past few years we have been told that Australian sites compare unfavourably with other countries. We are expensive, slow to start up and we frequently don’t reach our accrual targets. Sponsors tell us that this makes bring studies to Australia difficult. There are many reasons for this, some of which Australian Investigator Sites can address. Firstly there needs to be a change in how Investigator sites define themselves. Sites need to see themselves not only as deliverers of excellent clinical care but also as businesses. All successful businesses measure their business activities because they know that if they don’t measure they can’t manage. The business metrics a clinical trial unit needs to collect to sustain and grow your clinical trial units are associated with time, study subject accrual and money. Gathering these types of metrics will alert a manager to processes that need improving and enable a manager to showcase the sites strengths. In other words metrics enable managers to manage which leads to greater efficiency and growth.  ​

An update on the National PICF project (including pilot data)

There are two parts to an informed consent process – a verbal discussion plus a written component used to facilitate the discussion. The current written component of the informed consent process is not only long and complex, but often fails to accomplish its purpose – that is to provide information to a potential research participant and assist them in deciding if they wish to take part. In order to improve this very important aspect of informed consent for participants, a need has been identified to develop tools that provide all non-trial specific information in a friendly usable format (multimedia) to suit individual participant needs. Including: – Presentation of an updated PICF template comprising multiple parts. – Presentation of the results of pilot programmes. – Presentation of supporting materials including multi format and educational tools.

Risk based monitoring for investigator initiated clinical trials.

Risk based monitoring (RBM) is the practice of adjusting the frequency, type and quantity of monitoring of clinical trial data based on the levels of risk associated with the study protocol and site characteristics.  It has been gaining popularity over the last few years, with many sponsors incorporating RBM principles and practices into their management of sites. The Australasian Kidney Trials Network is an academic collaborative group with an established expertise in managing investigator initiated trials in kidney care.  Experience in this area has led to the development of effective risk based monitoring procedures which have been implemented and refined for use in their trials over the past 7 years.  In this presentation we will detail

  • the background in the development of RBM practices,
  • what is meant by risk based monitoring and how it is done,
  • the use of centralised remote monitoring technique including data quality audit
  • the advantages and disadvantages of RBM for both the sponsor and site,
  • how the “Risk” is calculated and how to reduce risk (and work load) at your site
  • Impact and outcomes of RMB in AKTN trials


Chairperson: Sue Mason, ARCS Australia