inform4.6 module a intro to inform v1.0...

Introduction to InForm for CTC Studies Course version 1.0 [27 Feb 2013]

Notes:This course provides an introduction to InForm version 4.6, including key terminology and concepts, as well as b i kill h i tibasic skills such as navigation.

The course is suitable for CTC or external staff in the following roles:

Clinical Trials Assistant

Data Manager

Site Data Manager/Study Nurse

Trial Coordinator

Project Manager

Other staff who want some basic awareness of InForm user interface e.g. Biostatisticians, Clinicians, Investigator / Co-Investigator

Prerequisites

Basic knowledge of Clinical Trials and Randomisation processes.

Competence in using web based software applications.

© NHMRC Clinical Trials Centre, 2013 1


Notes:This course is divided into sections as listed above



Notes:This section will give you an overview of the terminology and important concepts used in InForm, and introduce

t th “l k d f l” f th li tiyou to the “look and feel” of the application.

Throughout this course we will use screen pictures and examples from the training study used in the workshop. Nothing in the course is specific to any particular study. The training workshop will provide you with examples to use for practical exercises that do not rely on prior knowledge of any particular study protocol.



Notes:These are the key terms used in InForm.

• A hospital or clinic is referred to as a Site.

• A participant in the study is referred to as a Patient.

•A Visit is an event in the study at which certain activities are expected to take place, e.g. Randomisation, tumour assessment, drug dispensing etc. An event can contain more than one eCRF.

•An eCRF is an Electronic Case Report Form. In InForm this is a tab that is equivalent to a paper CRF or a section thereof. This is also just called a Form. The structure of the eCRF may differ from the paper CRF.

A It ti CRF hi h i ht l ll fi ld•An Item means a question on an eCRF, which you might also call a field.

•The Data Value is the value entered for an item, so the answer to a question on an eCRF.

•An eCRB is an Electronic Case Report Book, which is a patients entire eCRF record, so all the eCRFs together make an eCRB. It’s also called a Case Book.

• Submitting is when you ‘save’ data in the system. Until you click on ‘submit’ data is not saved.

• Return means going back to the previous page, so the same idea as using the ‘back’ button in your browser.



Notes:These are the key groups of software functions in InForm 4.6.

• Enroll is used to Register new patients

• Patients is used to View and enter patient data

• Queries is used to View, answer and manage queries

• Monitor is used to Perform SDV

• Signatures is used to Sign SAEs and CRBs

• Documents is not used in CTC studies - study documents are accessed via the home page

• Listings is used to Create simple custom data reports

• Admin is used to Create and manage user accounts and sites

• Reports is used to Run pre-defined reports and create custom reports

Users will have access to these functions depending on their user role, for instance, only CTC monitors will have access to the Monitor functionaccess to the Monitor function.



Notes:The details of these roles and the precise privileges they have are defined for each study; the table above is an

l lexample only.

In addition there are other internal roles used for ‘back end’ tasks, e.g. Data Systems and Read-Only, e.g for audit.

User Accounts (usernames and passwords) will be maintained by CTC Trials Staff, following appropriate training.

Roles will be maintained by CTC Data Management.



Notes:InForm is a typical web-based application and runs within Internet Explorer. You do not need to install any

i l ft PCspecial software on your PC.


Course version 1.0 [27 Feb 2013]Introduction to InForm for CTC Studies

Notes:

8© NHMRC Clinical Trials Centre, 2013


Notes:On the log in screen, enter your username and password

If this is the first time you have logged in to InForm you may be asked to change your password. This is a security measure; the password issued to you by the CTC is for single use only. You have to change your password the first time you log in, and then every 90 days thereafter.

Password tips:

Both your User Name and Password are cAsE seNSitIvE.

Passwords must be at least 8 characters in length.

Passwords must contain both letters and numbers, but must start with a letter.

Passwords must be changed every 90 days and cannot be reused.

Passwords in a web-based system are equivalent to your written signature.

Passwords must never be shared.

The first time you log in please also complete your email address question and responseThe first time you log in, please also complete your email address, question and response.

If you forget your password, this email address will be used by InForm to email a temporary password to you.

Please be very careful: if you ever forget your password, you will need to enter the response exactly as you typed it here, including capitals/lower case/punctuation etc.

If you exceed 3 unsuccessful logon attempts, your account will become inactive, i.e. you will be locked out.

NB: The ‘Forgot Your Password?’ link will still work even if your account is inactive – your account will be automatically re activated when you login using the temporary password


automatically re-activated when you login using the temporary password.


Notes:This is the trial home page

The name of the trial and your name will appear in the top left corner

There are buttons for home (to return to this page), help, and logout.

The navigation bar at the left will show different functions, depending on your user role

There a range of navigation tools at the bottom of the page, which we will explore in detail later

Specific to each study, the home page also contains CTC contact details and links to the protocol and other study reference documents.



Notes:If you want to change your password when it has not expired, click on your name at the top left of the screen.

You will see the same fields as when you change your password when you first login.

Enter your current password, then your new password and confirm new password.

It is not necessary to change the password recovery information (email, question and response), unless you want to change it, or have not entered it previously.g , p y



Notes:If you forget your password, enter your username and click the ‘Forgot Your Password?’ link.

You will be shown your Question, and must enter the Answer.

If the Answer is correct (including capitals/lower case/punctuation etc.), a temporary password will be emailed to you.

On your next login, you will be required to reset your password.

When re-setting an expired password, it is not necessary to enter your email address, question and response g p p , y y , q pagain, unless you want to change them.

Although these fields will appear to be blank, the existing email address, question and response will continue to be used, unless you choose to update them.

If your account is inactive because you have exceeded 3 unsuccessful logon attempts, the ‘forgot password’ link will still work – your account will be automatically re-activated when you login using the temporary password.

If you forget your answer, or do not receive the password recovery email, contact the CTC to have your password reset.

If you have not previously set an email address, question and response, the ‘Forgot Your Password?’ link will not work. Contact the CTC to have your password reset.



Notes:



Notes:There are 4 ways to navigate to patient data from the home page:

A. The navigation bar on the left, by clicking the option ‘patients’.

B. The patient finder, just below the navigation bar, where you can enter the patient number and click ‘Go”

C. The eCRF history in the bottom left hand corner, where you can click on hyperlinks for the last four pages you visited.

D. The patient/visit selector at the bottom of the screen, which will show all entered visits for your patients. You can navigate to a visit by selecting the site, patient and visit, and click ‘Go’.



Notes:If you click on Patients in the Navigation Bar, you’ll see the Patient Case Book List

•There is a Site Selector at the top of the screen. Select a site or ‘All Sites’ that you have access to.

Users with access to only one site will not see the dropdown list, just the name of their site.

•The eCRF Status Selector can be used to highlight forms that are started, incomplete, have queries, are frozen or are locked by selecting the relevant box.

•Each patient is listed on a separate line, with a set of traffic lights for each visit

•The page shows up to 12 patients per page, with a Page Selector at the bottom to access subsequent pages



Notes:Clicking a patient number will take you to the Time and Events Schedule for that patient

• The Time and Events Schedule lists all eCRF which need to be completed for each patient

• Each row shows the full title of the eCRF and the short name that will appear on the eCRF tab

• The eCRFs are arranged in columns corresponding to study visits

• The traffic lights depict completion status of each eCRFg p p

• Clicking on a traffic light will take you directly to that eCRF



Notes:Traffic lights indicate completion status of an eCRF or visit

Traffic lights update automatically upon submission of data

• No Lights means the form contains no data, i.e. not started

• A Red Light means that there is at least one open query

• A Yellow Light means the form is only partially complete, i.e. contains missing data

• Red and Yellow Lights means that there’s missing data and at least one open query

• A Green Light means all items in the form are complete• A Green Light means all items in the form are complete

• A Yellow flag means there is an answered query for CTC review



Notes:Traffic lights indicate the summary status of a visit in the Patient Case Book list.

NB: A green light means the visit is complete, not that the data is clean and correct.

It is the user’s responsibility to have and follow a data management plan to ensure clean and correct data.



Notes:Traffic lights indicate the status of each eCRF in the Time & Events Schedule



Notes:



Notes:Clicking on a traffic light in the Time and Events Schedule will take you directly to that eCRF.

•At the top of the eCRF is the visit ribbon. Click on a visit in the visit ribbon to navigate to that visit.

•Each visit contains eCRFs displayed as eCRF tabs. Click on any tab to navigate to that eCRF.

•On the eCRF, items are displayed in rows, with the question to the left and the data value to the right.

•Each item has a number of icons at the far right, and there are also icons at the top of the eCRF and the top of the screen.



Notes:This is an overview of icons. These will be covered in detail in Module B. But even then, you won’t need to learn th b h t if h i ith th i ill tithem by heart - if you hover over an icon with your mouse, the meaning will appear as a screen tip.

•Grey comment icon - No comments have been entered. Click to add a comment.

•Yellow comment icon - A comment has been entered. Click to view or edit the comment.

•The same icons appear at the top right of the form to indicate form level comments. A form level comment applies to all items on the form.

•Grey query flag - No query has been raised for the item. Add a query by clicking on the flag (CTC staff only)

•Yellow query flag - A query is open or answered. Click to view, answer or close the query, depending on your user rights.

•Green query flag - A previous query has been closed. Click on the green flag to view the query history.

•The Eraser icon indicates that data has not been submitted yet. Click to erase a value before it is submitted.

•Once you have submitted data, the eraser icon is no longer visible on the eCRF. But you can still access theOnce you have submitted data, the eraser icon is no longer visible on the eCRF. But you can still access the eraser icon to edit incorrect information in the data value, query or comments screen (detailed in Module B of this training)

•Grey audit trail icon - indicates that the current value is the initial data entry. Click to view the audit trail.

•Yellow audit trail icon - indicates that changes have been made to the item. Click to view the audit trail.



Notes:These are some icons that don’t do anything if you click on them, they’re just indicators

•An exclamation mark on an eCRF tab indicates that there is work to be done on that form, which might be missing data and/or open query and/or answered query for review by the CTC.

•An asterisk next to an item number indicates that the item is required, and you’ll probably find that the vast majority of items are required in CTC Inform studies

•A tick next to a form or visit traffic light indicates that the form has been at least partially SDVed. These ticks will only be visible to CTC monitors.

•A snowflake next to a form or visit traffic light means that the form or visit has been frozen, which means that data cannot be amended unless unfrozen by CTC.

•A padlock next to a form or visit traffic light means that the form or visit has been locked, which means that no further amendment is possible.



Notes:There are a number of ways to navigate within / between eCRFs.

•Click on a visit in the visit ribbon to navigate to that visit.

•Within a visit, click on any eCRF tab to navigate to that eCRF.

•The yellow arrow at the top left of the page navigates ‘up’ one level, e.g. from eCRF to Time and Events Schedule.

•The ‘Home’ link in the navigation bar navigates to the study home page.

•The ‘Return’ button at the bottom right of the screen navigates ‘back’ to the previous level, e.g. from eCRF to Time and Events Schedule.



Notes:Repeating eCRFs:

Some eCRFs are repeating, i.e. more than one instance of the eCRF can be entered by clicking ‘New’

Repeating eCRFs contain a Repeat Selector that can be used to view an individual instance or a Summary View.

Repeating Visits:

Some visits are repeating, i.e. more than one instance of the visit can be entered by clicking ‘New’.

Repeating Visits contain a Visit Selector that can be used to navigate to the relevant visit by selecting the date of visit.



Notes:Clicking on any icon next to an item, or the data value itself, navigates to the item details.

Every item has 4 screens in this view:

• Data Value(s): used to edit an item value

• Queries: to respond to a query on the item

• Audit Trail: to review the history of the item

• Comment: to add or review comments on the item

These functions will be covered in detail in Module B

•The yellow arrow at the top left of the page navigates ‘up’ one level, e.g. from the item details to the eCRF

•The ‘Return’ button at the bottom right of the screen navigates ‘back’ to the previous level, e.g. from the item details to the eCRF



Notes:



Notes:To print an eCRF, click the dropdown arrow next to [Select Action] at the bottom left of the screen

Select [Print Preview] and then click Apply



Notes:Patient, site and visit identifiers are added to every page of the eCRF, even if the eCRF prints on multiple pages

Click Print at the bottom right

Once the eCRF has printed, click Return to return to the normal eCRF view



Notes:Some items, sections and forms are programmed with specific help text. These will be underlined to indicate that h l t t i il blhelp text is available.

Click on the underlined text to access the help.

This text is study-specific, i.e. programmed specifically for the trial.



Notes:To access the InForm Help menus, click on Help, then select ‘InForm and Trial Reporting’.

This is standard help on the InForm software and is NOT study-specific, but it may be of interest.



Notes:When logging out of the system, it is important that you use the logout button, located in the left navigation bar.

Please DO NOT use the red X, as this leaves your session open in cyberspace, and leads to network congestion.

The logout button is located in the navigation bar. Logging out this way will ensure that your session is correctly terminated.



Notes:
