Checklist for implications of Data Protection

Data protection framework

• Register under the Data Protection Act with host institution
• Consider if waivers are required for collaboration outside the EU
• Consult with Commissioner if there is any uncertainty about the process

Implications for staff

• Ensure confidentiality clause in staff contracts
• Develop procedures for breaches of confidentiality
• Ensure staff aware of data protection protocols with trial office
• Identify lead person for DP issues

Implications for participants

• Must give consent to process all personal information
• Must be given accurate information regarding the use of data/samples collected both now and in the future
• Access to all information held, via a process developed by the trial office. The process will ensure correct participant identification. Use NHS systems where possible

Day to day management

• Only collecting data fit for purpose and approved by ethics committee and registered under the Data Protection Act
• Ensuring adequate security and restricted access to both the office and the computer network
• Ensure information held on participants is anonymised as soon as practically possible, depending on the trial design. That may be when an individual’s data collection is completed, and it is considered that the risk of emergency unblinding is minimal
• Document the reason for the timing of anonymisation of data

Simple solutions - paper

• Forms can be designed to include participants identifiers and data
• Store in locked (fire proof) filing cabinets
• Never leave data out on a desk overnight (or take out of the office)
• Plan access and archiving procedures (kept for up to 20 years) with your host institution

Simple solutions - electronic

• Password protected systems and email addresses
• Daily back-up - stored off site
• Consider encryption, coded identifiers

No simple solutions

• Electronic data collection
• Internet transfer
• Randomisation on the web

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This page was last updated 29th September 2003.