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EDGEv2 - A quick guide for Researchers - V1_2

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Research and Development Department
Version 1.2 – 23 February 2015 www.edge.nhs.uk
EDGE™Clinical Trials Management System
BACKGROUNDThe EDGE system was designed by the University of Southampton to assist in the collection of accurate and timely information for clinical trials, which incorporates finance, document management and SAE reporting.EDGE is a web based system and is totally secure, using 128 bit encryption SSL certification to ensure that all data transferred from the user to the server is encrypted.There is a complete audit trail of every activity carried out within EDGE, including time recording and date stamping every change within the system and a record of user log on and log off times.EDGE and the Data Protection Act (DPA) 1998Demographic data collection facilitated by EDGE allows NHS organisations to fulfil their duty of care to patients enrolled in clinical studies. The Research Governance Framework section 3.10 states that‘it is the responsibility oforganisationsproviding health or social care in England to be aware of all research undertaken in theirorganisation, or involving participants, organs, tissue or data obtained through theorganisation.’The Information Commissioner’s Office has confirmed thatSchedule 3(8) is likely to be an applicable condition for the collection and processing of the EDGE patient dataset. See appendix 2.Although the condition for processing outlined in Schedule 3(1) (“explicit consent”) of the DPA is likely to be impractical, this does not remove the overarching requirement of fairness under the First Principle of the DPA. In general, this means ensuring individuals are aware of how their data will be used. This is generally provided to individuals by way of a “fair processing notice” or “privacy notice” when their personal data is first collected. Trusts should as a matter of routine provide a generic statement on their public website or via leaflets on data handling and processing in their organisation.
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Portsmouth Hospitals NHS Trust and EDGE
How is the data used?
EDGE is also used in reporting to the Executive Team at QAH, MHRA and HIOW CLRN, who use the reports to decide on future funding and resources for on going facilitation for future trials.
Why does Portsmouth Hospitals NHS Trust use EDGE?
The Trust uses the EDGE system as it needs to be able to track patients recruited into clinical trials within the hospital and the PAS system has no way of recording this.
Why do I have to upload data in a timely fashion?
It is essential that the data in EDGE is as close to ‘real time’ as possible to give an accurate view of the number of patients involved in a clinical trial and to show researcher activity
What is EDGE?
EDGE is a revolutionary computer software system, which is transforming the way clinical research trials are managed in UK hospitals. It has won an NHS Innovations award.
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Adding a new patient
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Finding a lost patient?
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Updating patient details
Version 1.2 – 23 February 2015 www.edge.nhs.uk
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Updating patient details(Continued)
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Subsequent screening of a patient for the same study
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Locating documents
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Running recruitment reports
*A request has been made to the EDGE team to include pre-screened activity in the results
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Registering an Serious Adverse Event
*Currentlyyou are only able to record it as an ADVERSE EVENT but SERIOUS ADVERSE EVENT will be added shortly
Version 1.2 – 23 February 2015 www.edge.nhs.uk
NIHR Definitions
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Pre screening
Approached
Consent
Screening
Recruited / Randomised
** Due to the format of the default settings within EDGE currently, the following applies:Any patient recruited into a clinical trial at PHT needs to be uploaded to EDGE as far as recruited, only continue with the pathway if the patient is receiving treatment within the trial.
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NIHR Definitions(Continued)
Version 1.2 – 23 February 2015 www.edge.nhs.uk
Completed
On follow up
Treatment
Off Study(Rejected or Withdrawn)
** Reasons for withdrawal are currently under review by the EDGE Team

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EDGEv2 - A quick guide for Researchers - V1_2