Research and Development Department A Quick Guide to Using EDGE v2 for Researchers Version 1.2 – 23 February

EDGE™ Clinical Trials Management System BACKGROUND The 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) 1998 Demographic 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 of organisations providing health or social care in England to be aware of all research undertaken in their organisation, or involving participants, organs, tissue or data obtained through the organisation.’ The Information Commissioner’s Office has confirmed that Schedule 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

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

Adding a new patient From your home screen – select ADD A NEW PATIENT Select PROJECT required from drop down list For all non consented patients, ideally only use Patient Initials, Date of Birth and Date of Pre-Screened / Screened. Complete dates as required. (If you do not pre-screen or approach a patient then the same date as screened will need to be completed, as blank boxes will not be accepted). The trial may contain TREATMENT ARMS, if these are not already set up and they are required for the study, please contact the R&D Department who will arrange this. Version 1.2 – 23 February

Finding a lost patient? To find a pre-screened / approached / screened Patient Select the PROJECT from your recently viewed projects on the home screen (or search using the ‘Projects’ tab at top of page) You will now see the Project Main page details, you need to select sites from the left hand tab Select your hospital - you will now be on the ‘site’ level page for the project (red banner at top). Click on the ‘Patients’ tab under the red banner. You should then be able to select Filter by Patient status. If you choose the status required it will then filter to only show patients on your selected stage. Clicking on their name allows you to edit their details. Alternatively, you can use the search box and search by Surname, Hospital number etc. Version 1.2 – 23 February

Updating patient details You will now see the Project Main page details (green banner at top), you need to select sites from the left hand tab. Select ‘Filter by Patient’ status choose option required, it will then show you all your selected patients in that stage, then click on their name to enable editing. To change the edit patient’s name, date of birth or NHS number, select FULL Patient Record on the right hand side. Version 1.2 – 23 February Select the PROJECT from your recently viewed projects on the home screen (or search using the ‘Projects’ tab at top of page) Select your hospital - you will now be on the ‘site’ level page for the project (red banner at top). Click on the ‘Patients’ tab under the red banner. Continued overleaf.

Updating patient details (Continued) To change the patient’s hospital number or randomisation number, please select ‘edit details’ in the patient details section To change the patient status, select ‘edit patient’ to the right hand side Version 1.2 – 23 February

Subsequent screening of a patient for the same study Version 1.2 – 23 February If a patient has previously been screened and rejected for a study but may now be eligible again, the process for recruitment is slightly different. At the local number stage, when adding the patient, enter the patient’s hospital number and then add 2nd Screening. (For example – Q – 2 nd Screening For any future screening of the same patient, repeat the procedure but add 3 rd, 4 th screening etc.

Locating documents On the left hand side menu – select DOCUMENTS You will now see the Project Main page details, you need to select sites from the left hand tab. The current approved versions of all documents are on the front screen. There are three other files – CV / GCP / LOA (Researcher Certificates) PHT Approval Letters (Inc. Amendment Summary Forms Superceded Documents – All replaced documents Version 1.2 – 23 February Select the PROJECT from your recently viewed projects on the home screen (or search using the ‘Projects’ tab at top of page) Select your hospital - you will now be on the ‘site’ level page for the project (red banner at top). Click on the ‘Patients’ tab under the red banner.

Running recruitment reports * A request has been made to the EDGE team to include pre-screened activity in the results From the HOME page, select MY REPORTS Search for recruitment by selecting month or year that you wish to check Select MY RECRUITMENT The results will show the number of screened, recruited, rejected and withdrawn patients * Version 1.2 – 23 February

Registering an Serious Adverse Event * Currently you are only able to record it as an ADVERSE EVENT but SERIOUS ADVERSE EVENT will be added shortly From the patient details page, select EVENTS from the left hand side menu Go to the site level of the project, select the patient tab and find the patient required Complete the ADD PATIENT EVENT form details* Click ADD EVENT on the right hand side Version 1.2 – 23 February Select the PROJECT from your recently viewed projects on the home screen (or search using the ‘Projects’ tab at top of page)

NIHR Definitions Version 1.2 – 23 February Pre screening Approached Consent Screening A brief eligibility check prior to discussion and consent Discussed the trial with patient Date informed consent is taken Detailed study screening tests post consent to confirm eligibility and trial participation continues Recruited / Randomised Date entered into the trial (usually the same date as consent) ** 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. Continued overleaf.

NIHR Definitions (Continued) Version 1.2 – 23 February Completed When a patient has finished all involvement in the trial On follow up When a patient has finished treatment and is receiving follow up (may not be at PHT) Treatment At PHT this can only be completed for treatment trials, Off Study (Rejected or Withdrawn) EXAMPLES: 1. A patient has been pre- screened and rejected due to not meeting the Protocol criteria. 2. After the patient has been approached and they have refused to take part in the study (withdrawn) 3. A patient has consented to the trial but changes their mind, they are withdrawn. 4.A patient is no longer contactable and is therefore withdrawn from the study ** Reasons for withdrawal are currently under review by the EDGE Team