Clinical trials require careful management. At the very minimum, the investigator has an obligation to meet the regulatory requirements of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the National Health and Medical Research Council's National Statement.

Standard operating procedures describe the various aspects of trial activity in a transparent way to ensure accountability and reproducibility of the research activities. Examples of standard operating procedures for various Australian studies are available. 

Data management is another major area of responsibility for research teams. Researchers need to consider what data management system they will use, what processes and audit trails they will establish, and what mechanisms are in place to ensure data security. The CareSearch Research Data Management System is one system that supports the data collection for clinical trials in palliative care and can be used for single or multi-site studies.

File management is a significant task for any research project. The ICH Guideline for Good Clinical Practice lists the essential documents that should be kept. For larger or multi-site trials, a more comprehensive filing system may be required. A file master index may be useful. This would include a full listing of all files both those held at the individual sites and those held centrally. Versioning of trial documents may also be important to track changes to documents and to ensure currency.

Each trial should establish Key Performance Indicators (KPIs) to monitor specific aspects of trials and trial progress. KPIs could include items such as:

There are specific requirements regarding the archiving of trial data. As well as national standards, there may be state or institutional requirements. The Australian Code for the Responsible Conduct of Research provides some information on this.

This page was created on 25 March 2008.
Last updated 8 January 2011