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Trial planning

Data management plan

A data management plan (DMP) is a critical tool for ensuring the quality, integrity and responsible management of data in a clinical trial.

Creating a good Data Management Plan will safeguard data quality, ensure regulatory compliance, and support rigorous analysis and responsible data sharing. It will also ensure that all of the elements of the research data plan are in line with the FAIR principles (Findable, Accessible, Interoperable, and Reusable).

Here are some of the tasks you’ll have to complete during this step of your clinical trial: 

Consider the elements and document

  • data quality and integrity
  • regulatory compliance
  • efficiency and risk management
  • participant safety and privacy
  • data sharing and accessibility
  • storage
  • access and ownership
  • archiving and disposal.

Consider statistics

  • sample size calculation
  • randomisation and allocation concealment
  • blinding and masking 
  • statistical analysis plan 
  • statistical hypothesis testing
  • interim analyses and data monitoring
  • handling missing data 
  • regulatory requirements.

Consider tools for capturing data

  • what tools will you use to capture your data?

Create your Data Management Plan

  • create your DMP, taking into consideration the steps above
  • share with a colleague or statistician for checking
  • submit with your ethics application.
Risk assessment profile Human research ethics application
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Further reading

Learn more about this topic with our helpful articles.

A guide to creating a clinical trial data management plan

External resources

A curated list of resources from trusted sources on the web.

NHMRC’s Management of data and information in research guide
Fair Data Assessment Tool
Data governance in health research
Considering Indigenous data in research
Indigenous data sovereignty in health research
Australian Clinical Trial Education Centre
Society for Clinical Data Management
Survey tools in research: REDCap and Qualtrics
Data management & analytics for health care
Australian National Data Asset (HeSANDA) program

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