Introduction

1. Who? Advantages? Why? Introduction What? Purpose?

2. Imperial College Mission Statement • Imperial College embodies and delivers world class scholarship, education and research in science, engineering, medicine and business, with particular regard to their application in industry, commerce and healthcare. We foster interdisciplinary working internally and collaborate widely externally. • Healthcare research is essential to this mission

3. What is InForm? • An Integrated Trial Management tool designed to make data management of clinical trial data easier to handle and manipulate. • A web-based electronic data capture tool that enables site staff to enter data on research participants into electronic Case Record Forms to eliminate paper trails. • InForm™ has been adopted for the following reasons: • Increasing level of legislation and regulation covering healthcare research • Increasing expectations from funders about quality of trial and data management • Regulators increasingly target data management in inspections • Supplier of the product is the market leader with over 3000 trials in over 100 countries worldwide

4. What does InForm do? 1. Collects data from clinical trials Validates the entries 2. Allows monitoring and oversight of clinical trials Source data verification checks Freezing and locking data 3. Creates an audit trail Data entered/modified (who, when etc.) Queries raised/resolved Monitoring undertaken 4. Facilitates Reporting

5. Advantages of InForm at Imperial College London • Facilitates Governance - Imperial has to move to a consistency in approach • Trial Oversight - InForm is proven to be a robust system regardless the size, simplicity or indeed complexity of the trial, whether it be 3 or 300 patients • Audit functionality built in - Improved data retention, minimises missing data (including security and back up facilities) • Proven product - Ability to spread best practice in design of eCRFs, which will make auditing more effective

6. Advantages of InForm for the Individual User • Can be accessed from anywhere in the world where there is Internet • Validation functionality built in – regardless of the different individuals working on one trial, data will be consistent because the system will run according to certain rules • Data validated in real time • Improved in-trial monitoring. This will ensure consistent quality checking so that trial staff can take more ownership of their data. • Automatic audit trail creation for each individual data item so you can see all changes to data made by users • Intended to minimise administration by streamlining the data collection, data retrieval and queries

7. Imperial College InForm Users • There are different roles within clinical trial teams. In line with the regulations the configuration of InForm at Imperial College reflects the most common roles • Data Entry • Responsible for enrolling patients into the system and entering patient data • Typically a study nurse or researcher • Data Sign Off • Responsible for signing off data: • Typically this is the CI • Data Checker • Responsible for closing queries and source data verification • Typically a trial monitor • Read Only • Responsible for sponsor oversight of a trial • Typically a research manager

8. The InForm Environment • The following slides will show you some of the common • screens • features • functions • icons • status indicators • within InForm to prepare you for your e-learning modules

9. Log In • All users have a separate log in and password • Remember you must not • share user names • or passwords

10. Password Management • You will need to update your password when it expires • You will also need to re-log in after periods of inactivity

11. Home Page • The Home Page is the first page you will see when you log into your trial At the side in the Navigation Pane you see the main functions you can perform The design of the home page will be specific to your trial Details of sites and contacts are also provided At the bottom of the screen you can filter by site, patient and visit

12. The Navigation Pane • Always sits on left side of the screen • Clicking on one of the feature buttons takes you to the main InForm functions • You can also click on Help or Logout at any time and Home to go back to the Home Page • The functions available differ for the different types of users • The next few slides will show you about these main functions

13. Screening Log • Clicking on the button in the Navigation Pane takes you to the Screening Log • You can view • enrolment data • or add patients • to the trial • depending on • your role • Note that this is • screening for the • system only. • Clinical screening • screening comes later

14. Patients Page • Clicking on the button in the Navigation pane takes you to the Patients page • You can view • the status of all • the patients at • your site or in • the trial • depending on • your role • The traffic light • icons offer a • quick visual • overview of patient status

15. Traffic Lights • Blank Traffic Light - no data has been • entered for this visit yet • Green Traffic Light - data for the visit • is complete • Amber Traffic Light - data for the visit • is incomplete • Red Traffic Light - data for the visit • has queries • Red and Amber Traffic Light - data for • the visit is incomplete and has queries

16. Patients Page • You can filter for patients by site and status • You can highlight visits/traffic lights at different stages, for example, visits with queries • You click onto a • patient reference • to find the status • of all CRFs for • That patient

17. Patients Time and Events Schedule • Clicking on the underlined patient reference takes you to the Time and Events schedule • Traffic light icons • here show you • the status of • individual forms • within a visit • Again you can • use highlights to • help you go to • the forms you • need

18. Queries • Clicking on in the Navigation Pane will take you to the Queries page • You can view • trial queries • and filter by • site, patient, • status and • issuer • Queries can • be raised • automatically • or manually • by a Data Checker

19. Query Icons These will be shown against individual data items Blue flag – no queries exist Yellow flag – open query Green flag - There were queries in the past but these have now been resolved and closed

20. Signatures • Clicking on in the Navigation Pane allows you to view the Case Books and forms which have been signed off or still need signatures • If your role includes • signature rights • you will be • able to move from • this page to • sign off the Case • Books and CRFs • that require it

21. Documents and Admin • The two remaining links on the Navigation Pane are not used so frequently • Clicking on Documents will take you to an area where trial documents can be stored, for example, the protocol or list of FAQs • Clicking in Admin will take you to system admin information which you may never or rarely need to access

22. Additional Functions for Data Checker Users • Additional functions are available in the Navigation Pane for Data Checker users • Monitor takes you to Source Data Verification activities • Listings allows you to create data listings during the course of the trial • Reports provides you with comprehensive trial management reporting capability You will be provided with information on these functions if you need to use them in your role

23. Audit Trail • As soon as you submit your data to InForm by clicking an audit trail is created from the initial entry onwards • This icon indicates This icon indicates an entry • just an initial entry exists has been changed • The InForm audit trail contains the following headings: • Server on which the entry was created • Date and time of the data entry • User that created the entry • Content or value of what was entered • Reason for the entry

24. Reason for Change • Whenever an item of data is changed, the user is always prompted to provide a reason for the change • This change is reflected in the Audit Trail screen

25. Other InForm Icons • Some of the other common icons you will see when using the InForm system • A form or visit is frozen For Data Checkers only • while it is checked • Form or visit is verified A form or visit is locked • and ready for sign off • No comment has been • made on the item Yellow flag means answered queries that need to be resolved and A comment has been made closed • on the item

26. Other InForm Status Indicators • The exclamation mark indicates a form with queries or missing data • The yellow highlighting indicates The pink highlighting and red missing data underlined text indicate a query

27. Pop ups • InForm also has helpful pop ups that appear for example... • When you try to enter data in the wrong format • When you try to submit data that has not been • changed • When you try to submit a change but provide no • reason • Where you try to move to another form without • submitting data you have changed • Where you update a comment

28. Hover Help • Hover help pop ups also appear as reminders of functions and status as you hover your mouse over underlined and highlighted links and traffic lights

29. Next Steps • Thank you for your attention • You now need to go back to the web page to click on the next e-learning link