Introduction

Why?Who?

Purpose?What?

Advantages?

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

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

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

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

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

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

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

Log In

All users have a separate log in and password

Remember you must not

share user names

or passwords

Password Management

You will need to update your password when it expires

You will also need to re-log in after periods of inactivity

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

At the bottom of the screen you can filter by site, patient and visit

Details of sites and contacts are also provided

The design of the home page will be specific to your trial

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

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

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

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

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

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

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

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

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

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

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

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

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

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 verifiedA 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

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

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

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

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