1. Eudragene Application EUDRAGENE meeting 3-4 June 2004

2. System requirements Browser: Browser: –Internet Explorer 5.5 –Mozilla 4.5 Internet Connection: Internet Connection: –Recommended 128 bps (ADSL,Cable,etc) Printer Intermec EasyCoder C4 Printer Intermec EasyCoder C4

3. Why Web-based solution? Advantages Simpler design Simpler design Reduced interoperability problems Reduced interoperability problems No software installation No software installation Less support needed Less support neededDisadvantages Security Security Limited user- interface options Limited user- interface options

4. System security Our server operates following SSL protocol. Our server operates following SSL protocol. All network will be encrypted using HTTPS. All network will be encrypted using HTTPS. Database and Server protected by FIREWALL Database and Server protected by FIREWALL You will need a valid username/password to access database You will need a valid username/password to access database Passwords are stored encrypted in our database Passwords are stored encrypted in our database

5. How far we are? Pilot Interface ready Pilot Interface ready First Securities Issues established First Securities Issues established

6. Site Navigation This applications is based on user privileges This applications is based on user privileges Different users have different views Different users have different views The whole website has a navigation bar to access the functions The whole website has a navigation bar to access the functions

7. User types This site has three levels of users: –Plain Users –Centre Administrator (just one per centre) –Master Administrator (LSHTM) Note: Just Master Administrators has access to create more users (security reasons)

8. Plain User Functions Login Login Reports Reports Documents Documents Change password Change password Logout Logout

9. Basic functions Login in application Login in application –You need a valid username/password for login. –After 2 hours of inactivity you will be asked to login again. –Application saves details of each connection and movements Change your password: Please change your password in your first connection. After that, we suggest you changing it again in six months. Can be automatic update. Change your password: Please change your password in your first connection. After that, we suggest you changing it again in six months. Can be automatic update. Logout: System will disconnect you after two hours of inactivity. However you must disconnect (logout) after finish to use the site. Logout: System will disconnect you after two hours of inactivity. However you must disconnect (logout) after finish to use the site.

10. Reports Create reports: Create reports: –Create new report just entering (Pharmacovigilance) Report ID and category of drug reaction. –Optionally you can add more patient’s details –By adding a report, software will generate a unique Eudragene Study ID. Edit reports: With a search engine you could find existing report to edit. Possible search criteria: Edit reports: With a search engine you could find existing report to edit. Possible search criteria: –Eudragene Study ID –Report ID and Centre –Surnames and Centre Delete reports: Deleting a report will automatically archive the report. Data will never be destroyed. Delete reports: Deleting a report will automatically archive the report. Data will never be destroyed.

11. Documents Existing search engine allows you to search a specified report. Existing search engine allows you to search a specified report. After to choose a report application fills up documents with information specified report. After to choose a report application fills up documents with information specified report. Documents available: Documents available: Patient Invitation letter Patient Invitation letter Physician Invitation letter Physician Invitation letter Main questionnaire Main questionnaire Labels (Blood Sample) Labels (Blood Sample) And more (additional questionnaire, etc.) And more (additional questionnaire, etc.)

12. Centre Administrative Functions All plain user functions All plain user functions Physicians data Physicians data More options in documents More options in documents

13. Physicians Create Physicians: Create Physicians: –Add Physicians by entering details above –Mandatory information: Surname and forenames –Optional information: Phone and email (recommended) Edit physicians: Drop down list shows existing physicians, can edit this information. Edit physicians: Drop down list shows existing physicians, can edit this information. Delete physicians: Delete physicians: –Application allows deletion of physician(s) information –However it will not be able to delete physicians involved in a report (security issue)

14. Documents As a centre administrator, it is your responsibility translate and send us all documents so we can update the website: Edit documents: Edit documents: –Select a document to edit and change this values. –Application shows to you all the fields you need to translate for each document selected. –Save it once finished Pre-view: To be sure your translation is correct, you can pre-view this document before printing. Pre-view: To be sure your translation is correct, you can pre-view this document before printing.

15. Master Administrative Functions All Centre administrative functions All Centre administrative functions Users Users Centres Centres More options… More options…

16. Users Create Users: Create Users: –Add users just entering information requested. Username has to be unique –Mandatory information: Surname and forenames Surname and forenames Username and password Username and password Centre Centre Type of user Type of user Edit users: Selecting a centre from drop down list shows current users. Select one to edit. You can change all information except username. Edit users: Selecting a centre from drop down list shows current users. Select one to edit. You can change all information except username. Delete users: Application allows deletion of user details at any time. Delete users: Application allows deletion of user details at any time.

17. Centre Create Centre: Create Centre: –Add centre just entering details requested –Mandatory information: centre ID, Centre Name, Language –Optional information: Complete address details (recommended) Edit Centre: Select a centre from drop down list to edit Edit Centre: Select a centre from drop down list to edit Delete centre: Delete centre: –Application allows deletion of information about centres. –However it will not be able to delete centre involved in a report (security issue)

18. More options Full access to details from others centres. Full access to details from others centres. –Users –Reports –Physicians Full access to edit documents in all the languages Full access to edit documents in all the languages

19. What’s going on? Next steps of the project are: Document data entry Document data entry Reminders Reminders Statistics (response from doctors and patients). Statistics (response from doctors and patients). ADR category, drug category, ethnicity ADR category, drug category, ethnicity

20. Contact details Ferran Orsola, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK Email: ferran.orsola@lshtm.ac.uk ferran.orsola@lshtm.ac.uk Telephone: +44 (0)20 7636 3841 Fax: +44 (0)20 7580 6897 Please discuss security details with me before sending any confidential data via email.

21. Thank you very much