at University Hospitals Bristol NHS Foundation Trust V Page 1

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1 edge Quick Start Guide for Users at University Hospitals Bristol NHS Foundation Trust V Page 1

2 Introduction This document is not intended as a replacement for the edge User Guide but to enable research staff to quickly reach a stage where they are able to enter participant recruitment data into the edge system to meet their obligations to the Trust. Actions which need to be taken, as opposed to general information, are in bold type. The more the system is used the more useful it will become so we would encourage all staff expecting to remain active in research in the South West to spend time getting to know the system and its capabilities. Throughout this document you will be referred to the User Guide which can be found in the Global Documents on the edge system; and asked to direct queries to an Administrator. See list below. Anyone requiring access to the system either because they do not have an account or were unable to authenticate their details within the seven day timeframe should contact an administrator to activate their account Administrators Trial Units JCRU Tristan Grey BHOC CTU Jane Shackleton SH&N Trials Unit Christine Wood Eye Hospital Unit Andrew Nolan CTEU/Cardiac BRU David Hutton MCRN Marianne Jeffries Research Management Facilitators in R&I Debbie McPhee Genna Lettieri Karen Morgan Tom Parsons Emma Stoica Jess Bisset Katharine Wale Robyn Jackson V Page 2

3 Home Page From here you can update your contact details and manage your login. You are advised to check and update these details immediately From here you can track your recruitment across all projects Shortcuts to recently viewed projects You can enter details of your qualifications and training here. In particular we expect GCP training to be entered. General Documents contains organisational documents; Information Sheets, Workflows, SOPs, user guides and pro formas can all be found here Once you have logged in the system will open up on your homepage. Links found on this page relate to information of interest specifically to you V Page 3

4 Projects Tab Projects Tab Projects you are assigned to work on Projects happening across UHBristol Keyword search Other Search Options Click Project name to open the project record The default view on the Projects tab is to those projects you are assigned to. By clicking Organisation Projects you are able to view all projects taking place at UHBristol. V Page 4

5 Global Project Information The Green title bar relates to the overarching project level. Information that would be the same if the study were run at multiple sites can be found here. Contains information from overarching organisations eg sponsor, NIHR or networks Project level documents can be found/stored here Information at this level can only be edited by members of the project team (with manager access) at the organisation that owns the study If you are the Chief Investigator or Trial coordinator for a study run by UHBristol and do not have an Edit option, please contact an Administrator for this to be set up When viewing a study to which you are not assigned, only the Details page will be visible. Tabs and items in the sidebar will not be available to staff not working on the study. If you wish to develop a new study or join a study led by another organisation please contact an Administrator. V Page 5

6 Site Listing Click on site name to access site information V Page 6

7 Local Project Information Additional Local information regarding the project can be found here eg R&D number, application status Local workflows can be added/viewed here allowing for transparent processing An overview of recruitment (no patient details) can be found here The Red title bar relates to information about the project which is only relevant to the named site (UHBristol) Site level documents can be found/stored here Communication threads about the project can be posted in the notes field, and will be used for communication throughout processing Information at this level can only be edited by members of the project team (with manager access) at the named site If you are the Principal Investigator or Trial coordinator at UHBristol and do not have an Edit option, please contact an Administrator for this to be set up This is where information related to the processing and conduct of the study at this site can be found. All data should be completed and kept up to date by the Principal Investigator or local trial co ordinator. Changes to this information should be notified to the R&I Department, where possible to the member of staff named as the RMF Allocated on the attributes page. V Page 7

8 Set up Study Team Click to add staff to the project team. Staff Tab Local Project Team If members of the team do not appear on the list of users they will need an account creating. Please contact an administrator to do this. Tick if appropriate Staff with Manager access are able to edit the project record Tick if appropriate Staff with Clinical access are able to recruit participants and view patient level data Start typing research team member s name and select from options Select the member of staff s role from the dropdown When setting up a study the Administrator will give manager access to a member of the project team; usually the Principal Investigator or Trial co ordinator. It will then be their responsibility to add other members of the project team to the study and assign the appropriate access rights. V Page 8

9 Adding a Patient to a Study Whilst it is not mandatory to keep any patient identifiable data in the system, the more information that is kept the more useful the system will be. There is also the potential for improved patient safety enabling access patient related trial information in the event of an emergency. Patient data can be as little as a single reference number to complete contact information and some demographic data The Patients tab will only be visible/available to local members of the project team with Clinical access Click to add a patient Click on the patient name to access their details. Please refer to the User Guide for information about the Full Patient Record (including appointments) All participants recruited into studies at UHBristol from 1 st April 2012 must be reported through the edge system. If you wish to also include participants recruited to the study prior to that date, you may either add them manually or contact an administrator to arrange an import to the system of recruitment data. V Page 9

10 Recruiting a Participant 1. Enter a unique patient identifier This is the only mandatory patient data and may be whatever is sensible for a given project eg NHS number, Hospital number, randomisation code or study ID 2. Enter the patient contact details Completion of this information is not mandatory but completion of some, or all, will assist in making the system more useful to the research team 3. Enter additional patient related data Completion of this information is not mandatory but completion of some, or all, will assist in making the system more useful to the research team V Page 10

11 Entering Recruitment Data Enter patient recruitment data All dates above the participant s current status must be completed in date order. If for example there is no pre screened or approached stage then a date earlier than the consented date must be used. In general a default of 01/01/1900 is used If completing data on behalf of another (Clinical) member of the study team they can be selected from the dropdown If you are the chief investigator for a study you can select which of these items you wish to be collected at the project set up stage. Please refer to the User Guide or discuss with an Administrator Whilst it is only mandatory to enter the Recruited/Randomised date, full completion of recruitment information will allow accurate tracking of patient status and an indication of workload (eg studies that may require large numbers screened to find a few potential participants, or studies with high dropout rates) V Page 11