Managing Data

This can be divided into 2 areas,

  1. The Data Management Plan – which is part of the study protocol.

  2. Data Management – for the collection and management of your study data.

Data Management Plan (DMP)

National Statement guidance

The National Statement (external site) (Section 3) provides guidance on what needs to be covered in the Data Management Plan for clinical trials. The section is most helpful when read in its entirety. Below is the specific section that can be used as the DMP outline.

Element 4 – Collection, Use and Management of Data and Information. The key questions include:

  • What data or information are required to achieve the objectives of the project?
  • How and by whom will the data or information be generated, collected and/or accessed?
  • How and by whom will the data or information be used and analysed?
  • Will the data or information be disclosed or shared and, if so, with whom?
  • How will the data or information be stored and disposed of?
  • What are the risks associated with the collection, use and management of data or information and how can they be minimised?
  • What is the likelihood and severity of any harm/s that might result?
  • How will the collection and management of the data or information adhere to the ethical principles in Section 1 of this National Statement?

Template options and further guidance

Data Management

WA Health supports the use of REDCap (external site) which is a secure web application for building and managing online surveys and databases. It is an internationally established model specifically set up to support online and offline data capture for research studies and operations.

REDCap was initially developed in 2004 by Vanderbilt University in the United States. The REDCap Consortium, also founded by Vanderbilt, has been created as a collaborative, international network of more than 2400 institutional partners in over 115 countries which freely contribute the ongoing development of the software. REDCap now has over 590,000 total end-users using the software for more than 450,000 ongoing research studies worldwide. REDCap is an open sourced application and is free to use by non-for-profit, or governmental institutions.

All REDCap databases are held on the Department of Health website.

REDCap Training

There are REDCap training sessions available. If you wish to be alerted to these and other research related training and seminars please email, SUBSCRIBE to scgh.research@health.wa.gov.au

Other related information

Last Updated: 29/09/2021