Managing Data

Data Management Plan (DMP)

National Statement guidance

The National Statement (external site) 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

• Research Data Management Toolkit: Planning (external site)
• Stanford Libraries - data management plans (external site)
• Data Management Plan template (Word)

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.