Confidentiality of Information

Confidentiality of information

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Daslne Data Monitoring Plan

Daslne is the database of children with an autism spectrum disorder diagnosis living in the North East of England (Northumberland, Tyne and Wear). Its aims are to inform service planning through providing an overview of numbers and needs of children, and to support representative recruitment to high quality research studies. Daslne is a partnership between parents, professionals and researchers. At the end of 2014, there were 1500 children on the database.

Daslne has a Data Monitoring Committee (DMC), with independent Chair and membership. Their role is oversight and monitoring of the conduct of Daslne to ensure confidentiality of participant data and the validity and integrity of the Daslne database.

The database functions include:

  • confidential registration of participant details and levels of consent,
  • storing the parent-provided and professional-provided information about each child (gathered either by paper or entered by parents through the secure website).
  • updating information on individual children as finance allows, by approaching families again.
  • downloading non-identifying summaries of data.
  • sifting groups of families to be approached on behalf of approved research studies, and sending prompts to non-responders.
  • sending information and newsletters (paper or electronic) to families who opt to receive this.

Principles of monitoring data

  • Monitoring should be commensurate with risks
  • Monitoring should be commensurate with size and complexity

 

Practical and Implementation Issues:

Responsibilities of DMC

  • The DMC is responsible for oversight of monitoring. Oversight of monitoring activities is distinct from the monitoring itself which is the responsibility of the Daslne Director.
  • Oversight of monitoring ensures that data monitoring plans are in place, and that the quality of these monitoring activities is appropriate.
  • The DMC receives and evaluates an annual report from the Daslne Director.

Responsibilities of Daslne Director

  • Prepare, in conjunction with the database IT specialist (Richard Hardy), a written plan for data and safety monitoring.
  • Follow a timetable for ongoing monitoring of the database functions.
  • Oversee monitoring activities.
  • Respond to recommendations that emanate from monitoring activities, and record actions taken in a confidential spreadsheet.
  • Inform the DMC chair annually of the outcomes of monitoring, and actions taken in response to recommendations.
  • Ensure that data confidentiality is maintained during all phases of monitoring, and response to monitoring recommendations, by ensuring no information which could potentially identify individual families is recorded in monitoring documents.

Performance of Data Monitoring

  • The integrity of the online data entry by participants will be reviewed in terms of accuracy and completeness annually, by the Daslne IT specialist (Richard Hardy) in conjunction with Newcastle University IT Department (Steve Williams, Director).
  • The safety of the electronic database will be checked in the same way.
  • A rolling programme of double data entry will be followed, to check for inaccuracy of basic data entry by the Daslne project team, and also additional entry such as recruitment to research projects.
  • Adverse events will be logged, such as when participants’ preferences for mode of contact have been overlooked. Analysis of actions required to prevent re-occurrence will also be logged.