Manual

MediCase eCRF is an easy, efficient and user friendly web-based eCRF system. It is entirely run in your common web browser and there is no need to install any new software on your computer. It does, however, require that you are on-line at all times that you are working with MediCase eCRF.

This manual assumes that you are familiar with research and clinical trial basic concepts and terminology. The manual is generic and does not provide information specific to your study protocol or registry.

The manual is divided into main chapters for different user scenarios. This chapter (INTRODUCTION) is intended for all users, while other chapters may be primarily intended for certain user roles (see User Roles for more information about user roles). The user role(s) for which each main chapter is primarily intended for is noted at the top of each chapter.

MediCase eCRF supports most common modern web browsers:

• Chrome
• Edge
• Firefox
• Safari
• Modern mobile devices

If you are using another web browser than those listed above, full functionality cannot be guaranteed.

This manual should answer most questions you may have regarding how to use MediCase eCRF. Each study or registry will also have a designated support point of contact who you should turn to if you are in need of additional user support.

Every user must have a valid user account in order to log in and use MediCase eCRF. When you are invited to a study, you will receive an email with instructions on how to create your account.

MediCase eCRF is entirely web-based, and you login at https://login.medicase.se.

When logged in, you can open the eCRF for the studies you participate in

Once logged in, you can open the eCRF for the studies you participate in in the list of studies. In the left menu you find links to update your profile, change password and setup 2-Step verification. Here you can also logout from the site, including all studies you have open.

Clicking the ‘My study profile’ links next to each study let’s you view the user roles your are assigned in the study and configure your personal settings in the study, e.g. if you wish to receive ‘SAE notifications’. The settings available depend on the study configuration.

2-step verification (often referred to as two-factor authentication) is a way of increasing the protection of your account. If 2-step verification is activated, a user must verify their login with a second step (read more about the seconds step below), besides the username and password. In this way, an unauthorized user is prevented from accessing the eCRF by just knowing the password. However, to simplify the login procedure, the browser can “remember” the login so that on that computer it is sufficient to have username and password for 30 days before a new verification is required.

Study setting

Most studies require 2-step verification for all users. Even if the study isn’t setup to require it, we strongly recommend all users to activate 2-Step verification for enhanced security.
The requirement for 2-step verification does not apply to subjects who log into the ePRO function. Subjects may log in with username and password only, or using a login link included in an email or SMS notification, but they will of course only be able to enter forms in their own patient surveys.

Configuring 2-step verification

2-step verification is configured in the user portal, by clicking the ”2-Step Verification” option in the menu.

Configure 2-step verification by clicking ”2-Step Verification” in the menu.

Click ”Enable” on the next page, and then verify your password. On the password displayed, you may configure the method, or methods, you wish to use as your second step at login. You may specify more than one method for verification and may then choose which method you want to use at login. We recommend that you always configure the SMS method, even if you want to normally want to use a different method, because SMS is a good backup method.

The 2-step verification configuration page

SMS

With the SMS method you receive a verification code in an SMS message sent to your phone at login. You enter the code on the MediCase eCRF login page when you have logged in with username and password.

With the SMS method, you get a code sent as an SMS message at login. Enter the code on the login page to complete login.

Authenticator app

You can install an authenticator app on your phone or tablet, which will generate a code you use to verify your login. MediCase currently supports the apps Google Authenticator and Microsoft Authenticator. The app will be uniquely linked to your account and can only be used to login your own user.

With the Authenticator app method you read a code in an app on your phone at login. Enter the code on the login page to complete login.

Smart card

You may use a so called “smart card”, a plastic card with a chip used for login, to verify your MediCase login. For the cards to work with MediCase, the cards must be issued by an organization trusted by MediCase’s security system. Currently SITHS cards are supported, being the dominant card issuer in Swedish health care. If you have the need to support other smart cards, please contact us at MediCase.

The computer you are using must have a card reader. We recommend that you also configure the SMS method to login on devices without a card reader.

If you have a SITHS smart card, enter it in the computer’s card reader at login and enter the PIN card for your card.

Login options

When you verify your login using your 2-step verification method you may choose to check “Remember this device”. If so, MediCase will not ask for your 2-step verification method on that specific device and web browser for 30 days.

There is also a ”More options” link that you can use if you want to use another verification method than your default method, or if you need help resetting your 2-step verification.

What happens if I can’t login?

When you have activated 2-step verification for your account and don’t have access to your phone or your smart card you use to verify your login, MediCase can’t send you reset information to your email address for security reasons. However, we have added a way to reset the 2-step verification. If you request reset a “user manager”, i.e. a user that has permissions to add and manage users in a study you participate in, may help you login to your account and re-configure the 2-step verification. Click “More options” on the 2-step verification login screen and then click “Reset 2-Step verification”.

Users are added, edited and deleted in the “Users” management page, located in the “Administration” section. To manage users, you must be assigned the  “User Manager” role. A user manager may add User Manager roles to other users, delegating the responsibility to manage users for the study.

The “Users” management page

There are various user roles, and each user account may be associated with one or several roles. The functions and options available to you when using MediCase eCRF will differ depending on the user role(s) associated with your account for the current study or registry.

Most user roles may be applied in study scope or site scope.

Study scope

A study scope role is applied to all subjects on all sites in the study.

Site scope

A site scope role is applied only to subjects on a specific site only.

Subject data and personal identifiers

The term subject data is used to group most information stored about a subject, such as initials, demography, informed consent and entered forms.

However, certain pieces of information are marked as personal identifiers, because they maybe used to easily identify the individual connected to a study subject. Personal identifiers include the subject’s full name, personal identification number (such as Swedish “personnummer” or any other national identification number or social security number), email address and phone number. If any of these identifiers are entered in the eCRF, access to these identifiers are covered by specific user roles (see “Personal Identifier Viewer” and “User Manager (personal identifier roles)”). A user role given read access to subject data doesn’t give read access to personal identifiers, unless states otherwise.

User roles are assigned in the User Manager tool, available for all users with any “User manager” user role. The user manager tool is found by clicking “Admin > Users”.

Click on the user you wish to manage, and then “Edit roles” on the user information page being displayed.

Manage user roles by clicking “Edit roles” on the user information page.

You then enter the “Edit user roles” page. On this page, you assign new roles or delete existing ones. Click “Save” to save the assigned roles.

To add a new role, you click on the role you want to add in the “Add role” section.

When assigning a user role in the User Manager, first select the role to assign.

In the next step, a description of the role is displayed, and you can select for which site the role should be assigned.

When you select a role that can be assigned study wide (for all sites), you may select the option “All existing and future sites”.

From the start only the most common user roles are listed in the “Add role” section. Click “Show all roles” to display all available roles in the study.

When viewing any user, you can see a description of their assigned user roles by clicking the information icon.

To add a new user, go to the “Users” page in “Administration” (you need the “User Manager” role to access the Users page), and then click “Add new user”.

Add a new user from the Users page in Administration

On the “Add user” page, enter the email address of the new user, assign which role the user shall have in the study and then click “Save”.

To add a new user, enter the email address of the new user.

Then, select the user role(s) the user should have in the study in the “Add role” section, following the same instructions as in “Assign user roles”. Several roles may be added.

Select the user role(s) the user should have in the study in the “Add role” section.

Click “Save” to add the user to the study.

When the user is added, the user will receive an email with instructions on how to access the eCRF. If the user doesn’t already have a MediCase account, the email will include a link to register for a new account.

Users marked as “demo only” only have access to the “Demo mode” of the study, and can not view or edit any real study data.
If a draft version of the eCRF is available for preview, demo only users also may preview the draft (accessing only test subjects).

A user is marked as “demo only” by clicking the “demo only” checkbox when adding the user.

Adding a “demo only” user

You can change the “demo only” setting for existing users in the “Edit roles” section.

The layout of MediCase eCRF, once logged in to a study

On smaller devices, such as smart phones, the layout is more compact

Once logged in, you may navigate the site using different menus.

The page header contains a navigation menu, the study name and the logged in user, linked to a profile menu.

Clicking the navigation menu button opens the navigation menu. The navigation menu contains links to all sections in MediCase eCRF.

The navigation menu

Clicking on your name to the right in the page header opens the profile menu. This menu contains links to your profile settings, the list of all MediCase studies you participate in, and a link to logout from the system.

The profile menu

To the left of the page content, a sidebar is displayed. The sidebar contains shorthand links to the most used sections of the system. The sidebar is not displayed on small screens like smartphones.

The sidebar

Click on the expand icon (double arrow) at the top of the sidebar to expand the menu and see the section names.

Click on the expand icon to show the section names in the sidebar

MediCase eCRF has a demo mode, allowing users to safely learn how to use the system or to try things out without interfering with data for real subjects.
To access demo mode, select “Demo mode” in the navigation menu (or in the sidebar menu).

Select “Demo mode” in the navigation menu to enter demo mode

When in demo mode, there is a red banner on the top and bottom of the page to aware you of this. To exit demo mode, press the ‘exit demo mode’ button in the demo mode banner, as shown below.

In demo mode, a red banner in the page header is always displayed

As it says in the banner, only demo subjects are displayed. This means that you do not have to worry about accidentally making any changes for real subjects.

Data is entered into forms, and sets of forms are in turn grouped together into visits.

The visits may (depending on the study setup) be further divided into stages:

• Screening
• Study visits
• Follow-up

In order for a subject to move from the Screening to the Study visits stage, all data entry items involved in any criteria for subject inclusion must be completed (these criteria will differ by study and how the study is set up, but at minimum it will include given Informed Consent and fulfilling all inclusion/exclusion criteria).

When data entry is completed in all Study visits, the subject enters the Follow-up stage.

The data collection process follows a flow, where each form (for a given subject and visit) has its’ own status within this flow. The goal is to eventually get all forms for all subjects to “Completed” status. The flow, i.e. the path to “Completed” status, differ between different setups, specifically between studies and registries.

The progress status of a form is displayed using a bar of one, two or three colored boxes, depending on the study’s use of monitoring and signing.

Example of a form progress status

Each box in the bar shows the status for a specific step. Data entry is always the first step. Other steps are monitoring and signing, which both are optional. If the study uses both monitoring and signing the status bar contains three boxes, where the left box is data entry, the center box is monitoring and the right box is signing. If the study contains only signing only two boxes are displayed (data entry and signing) etc. If you point at a status bar with the mouse, a description of the steps is displayed.

Point at a status bar to view an explanation of the status colors

Icon	Status	Status description
	Horizontal bar	The boxes show the status for the steps data entry (left), monitoring (middle) and signing (right).
	Vertical bar	The boxes show the status for the steps data entry (top), monitoring (middle) and signing (bottom).
	Not started	A blank box means that the step is not started.
	Ongoing	A half-filled yellow box means that the step is started, but not completed.
	Completed	A green box means that the step is completed.
	Warning	A red triangle means that the step contains a warning, e.g. a form that is rejected by the monitor.
	Locked	When a data manager has locked the form or visit, a padlock symbol is displayed.

When a subject’s visit is displayed in the subject list or on the subject page, a progress status bar is displayed visualizing the total progress status of the forms in that visit.

Icon	Status	Status description
	Not started	None of the visit’s form is started
	Ongoing	At least one of the visit’s forms is started, but not all are completed (and no form has status “Warning”)
	Completed	All the visit’s forms are completed
	Warning	At least one of the visit’s forms has status ”Warning”

Primarily intended for site staff (user roles ‘Data Entry User’, ‘Local Investigator’, and ‘Form Entry User’).

When opening the eCRF, the start page contains general information about ongoing activities in the study and links to the most common sections.

The start page is always accessible using the “Home” icon in the menu.

The sections displayed on the start page depend on your user roles in the study. In the “Subjects” section you have links to the latest added subjects, a quick subject search function and a link to the complete subject list.

In the “Subject” section you can search for subjects by their subject and/or screening numbers.

Other sections like “Monitoring”, “Queries”, “Adverse events”, “Signing”, “Locking” and “User Management” will be displayed based on your user roles, and contain summarized information about tasks to be done.

What sections are displayed on the eCRF start page depend on your user roles.

Access the subject list using the “Subjects” icon in the sidebar menu

By clicking the “Subjects” icon in the sidebar, or selecting “Subjects” from the navigation menu, a subject list will be displayed. You will only see subjects from the site(s) to you have access to.

At the top of the subject list there are features to filter the list (under the headers Subject, Site, Group and Status).

In the Visits column you can see the subject’s progress in the data row. There is one progress status bar for each visit (tip: hover the mouse over an icon to see which visit).

In the Warnings column various system generated warnings may appear.

Refer to the status/warnings icon legend at the bottom right of the page

To add a new subject to the study, click “Add a new subject” on the start page. You can also click “Add a new subject” from the subject list.

You may add a new subject directly from the start page

You may also add a subject from the Subject List.

When adding a subject, enter the basic information that you are prompted for about the subject, and click Save.

Clicking a subject in the Subjects List (see Subject List), will open that subjects home page. An example of which is shown below:

On this screen you can see a graphical presentation of the visits applicable for the subject:

In the lower part of each visit box the date the visit was either opened or planned is displayed (or ‘No date planned’ if the visit is not yet neither opened nor has a planned visit date). A visit that is open(see Open Visit) will have a green color indication. A visit that has a planned date that has passed without the visit yet has been opened will have a red color indication.

By clicking a visit, details about that visit, including all forms that visit contains, will displayed in the lower section of the page.

If the study uses multiple study phases, like “Run-in”, “Study”, “Follow-up”, the study phases are displayed as bars above the corresponding visit boxes. By clicking the study phase bars, you can expand or collapse visits in that phase.

The study phases are displayed in bars above the visit boxes. Click the study phase names to expand or collapse the visits in that phase.

Click the ‘View subject details’ link to open a window that displays information about the subject.

A dialog will be displayed containing detailed information about the subject:

The subject details dialog

In the subject details window, you may click the ‘Edit’ button to edit some basic subject details (such as subject initials).

If the study/registry is using the ePRO module (i.e. any questionnaire that the subjects answer themselves directly in MediCase eCRF), you can click “Log in as this subject” in the subject details dialog to switch to subject mode (i.e. log yourself out, and log in the subject instead).

Clicking “Log in as this subject” in the subject details dialog will open the eCRF in subject mode

Once logged in as the subject, a special interface will be displayed where only the subject’s forms and questionnaires may be answered. You can then safely hand over the device to the subject, the logged in user has no permission to modify any other data than the subject’s forms.

If the page gets locked while in subject mode after using “Log in as this subject”, you can use both the subject’s password and your own password to unlock the page. The subject will still be logged in though, even if you enter your own password.

Note that if you yourself want to continue using MediCase eCRF with your own permissions once the subject is done, you will need to log out and then log in again.

The subject may also log in to MediCase eCRF from another computer or device, e.g. from their home or mobile, using a username and password. See “4.1 Subject Login” for more details.

Before data can be entered into the forms of a visit, that visit must be opened. To open a visit, first select it by clicking the applicable visit box in the graphical presentation on the Subject Page (see Subject Page) and then click the ‘Open visit’ button below the visit description.

The visit date is pre-filled with today’s date, but you can enter any date in the ‘Visit date’ field. You can change the visit date later in the ‘Visit information’ form.

In order to enter data, first go to the subject’s Subject Page (see Subject Page), and in the graphical visits presentation click the visit for which you want to enter data. If the visit has not previously been opened, then go ahead and open it (see Open Visit).

Click ‘Enter’ for the form that you want to enter data into:

The form will open up for data entry. Refer to the sub-chapters below for further details about data entry features available.

NOTE: You must save each form by clicking either of the ‘Save as completed’ or ‘Continue later’ buttons found at the very bottom of the form (for further details, see Save & Continue Later).

Depending on the setup of each field, there may be warnings and errors that will trigger if illogical, unlikely or incorrect values are entered.

Warnings flag for value that might be correct but that are unusual/unlikely. If a warning is triggered, a warning message will be displayed (yellow background) next to the field. You should verify that the value is correct and not simply a mistype or some other kind of mistake. If any warnings remain on the form when you try to save it then you will be notified, but you have the option to continue saving with the values as they are.

When a warning is displayed, the form can be still be saved as completed

Errors flag for values that cannot possibly be correct. Errors will also be triggered if mandatory fields are left empty, or values that are fundamentally wrong for the field (e.g. if you try to enter a text value into a field that is expecting a numeric value). In all cases, MediCase eCRF will not accept a value that has triggered an error. If an error is triggered, an error message will be displayed (red background) next to the field. Forms that contain errors cannot be saved as completed (see Form Flow, and Save & Continue Later).

When an error is displayed, the form can’t be saved as completed, but can be saved using “Continue later”

If a (mandatory) field cannot be completed with a relevant/correct value (e.g. a measurement failed to produce a result, the subject was not willing or able to perform a specific procedure, or something was simply missed out by mistake) so that you do not have a value to enter, you can mark that field as omitted, unless the field is included in eligibility criteria, randomization rules, stratification rules etc. You do this by selecting “Omit value” in the form field action menu, and entering a comment explaining why the value is missing.

Most values can be omitted when entering a form.

When a field is omitted, the input section is grayed out, and an omit panel is displayed, including icon buttons to edit the omit comment and un-omitting the field.

When a field is omitted, an omit panel is displayed, with icons to edit the comment and un-omit the field.

For studies started before June 2020, the form entering page may look slighly different when entering forms. In those forms, values are omitted by clicking the “cross” icon () in the right margin. When omitted, the icon will be colored red ().

If you want to enter a data entry comment regarding an entered value, select “Add a comment” in the form field action menu, and then enter your comment. The comment will be visible for any user viewing the entered form, and also be included in audit trail.

Add a data entry comment by selecting “Add a comment” in the form field action menu

When a field is commented, the comment will be displayed in a comment panel below the field value. The panel includes icon buttons for editing and deleting the comment.

When a data entry comment is added, the comment is displayed in a panel below the value

For studies started before June 2020, the form entering page may look slighly different when entering forms. In those forms, values are omitted by clicking the “cross” icon () in the right margin. When a comment is added, the icon will change to a comment icon ().

Once data has been entered into a form, the form must be saved.

If you are finished with the form, use the ‘Save as completed’ button (at the bottom of the form). If there are any errors on the form (see Errors & Warnings) you will not be allowed to save using this button without first correcting the errors. If there are any warnings on the form, you will be notified and given the option to make any edits before saving. When the form is saved, the form will be set to status ‘To be monitored’ (if the study uses monitoring), ‘To be signed’ (if the study doesn’t use monitoring) or ‘Completed’ (if neither monitoring nor signing is used).

If the form is not fully completed (e.g. if there are some values that are not yet known, or if there are errors on the form that cannot be corrected until later), use the ‘Continue later’ button. When using this button, the form will be saved regardless of any missing values or errors, and the be set to ‘Ongoing’ status (see Form Flow)

Save and continue buttons when entering a form

In some forms, the questions are divided into several pages. In such forms, the pages are displayed as blue boxes above the questions. You may click a page box to go to a specific page, but the normal flow is to answer the questions on the first page and then click ‘Next page’ to view the next page.

Entering a multi page form

On the last page there is a ‘Save as completed’ button which will save the form as completed.

The “Save completed” button on the last page of a multi-page form

On all pages, you may use the ‘Continue later’ button to save the form as uncompleted and continue entering the form at a later time.

The current page number is displayed in a page bar above the form  fields. To the right is a menu button, that will open the page menu. The page menu displays the entering status of all pages (a green check mark indicates that the page is completed). By clicking a page in the page menu will open that page. Your changes on the current page will be saved.

The page menu in a multi-page form

Adverse Events (AEs) are entered in a somewhat different way than how other forms are filled out. To add an adverse event, select the “Adverse events” box in the “Additional forms” section. Click the “Add adverse event” link.

Adding an adverse event

Once adverse events have been added, the number of AEs added will be displayed in the “Adverse events” box, as well as the total progress for the forms. If you click the box, a list of the added adverse events will be displayed, and you can view and enter them just as any other form.

The list of adverse events added for a subject

A form that is saved using the ‘Continue later’ button will remain in status ‘Entering’ and can be edited using the ‘Enter’ link (see Enter Data).

To edit data in a form that is saved as completed, you must re-open the form back to the ‘Entering’ status before the form may be edited.

To re-open a form, click ‘Reopen’ for the form you want to edit on the Subject Page (see Subject Page):

Reopen an entered form

To open a form to view data in read-only mode, click the looking glass icon in the View column on the Subject Page (see 2.3 SUBJECT PAGE):

View entered forms

To view the audit trail for a value entered in a form, open a form in either entry/edit or view mode (see Enter Data or View Data). Depending on the form page you are using, you view the audit trail by clicking the  icon to the right of the form field, or selecting “Audit trail” in the form field action menu.

When entering forms in newer studies, the audit trail for a form field is found by selecting “Audit trail” in the form field action menu.

When a subject is to be included into the study, all criteria for inclusion are evaluated and if any criterion is not met MediCase eCRF will not allow the subject to be included. This means that all questions involved in any such criterion must have been answered in the eCRF. These criteria will always at minimum be:

• All study inclusion/exclusion criteria questions must have been answered (and all criteria met)
• It must have been recorded that the subject has given informed consent (normally this is recorded when adding a new subject and/or on the inclusion/exclusion criteria form).

In some cases, a study may have been set up to require additional fields to have been completed before inclusion is allowed (e.g. baseline variables required for stratification into analysis subgroups).

In order to include a subject, click (unless already selected) the ‘Inclusion’ visit box in the graphical visit presentation on the subject’s Subject Page (see Subject Page):

Including a subject, when subject groups are assigned manually

Select which subject group the subject should be included in and click the ‘Include subject’ button to include the subject.

MediCase eCRF will give error messages and will not allow the inclusion if any criteria (as mentioned above in this chapter) are not met.

Once the subject has been registered as included in the study, any previously hidden visits that only apply to included subjects will now appear in the graphical visit presentation.

When a subject is to be randomized into the study, all criteria for inclusion are evaluated and if any criterion is not met MediCase eCRF will not allow the subject to be randomized. This means that all questions involved in any such criterion must have been answered in the eCRF. These criteria will always at minimum be:

• All study inclusion/exclusion criteria questions must have been answered (and all criteria met)
• It must have been recorded that the subject has given informed consent (normally this is recorded when adding a new subject and/or on the inclusion/exclusion criteria form).

In some cases, a study may have been set up to require additional fields to have been completed before inclusion is allowed (e.g. baseline variables required for stratified randomization).

In order to randomize a subject, click (unless already selected) the ‘Randomization’ visit box in the graphical visit presentation on the subject’s Subject Page (see Subject Page):

Including a subject when randomization is used

Click the ‘Randomize subject’ button, and confirm (or cancel) the inclusion on the confirmation page.

The randomized group (arm) will then be shown. Note that from this point the group will also be displayed in e.g. the Subject List (see Subject List)

MediCase eCRF will give error messages and will not allow randomization if any criteria (as mentioned above in this chapter) are not met.

Once the subject has been registered as randomized in the study, any previously hidden visits that only apply to randomized subjects will now appear in the graphical visit presentation.

A subject can be excluded before randomization/inclusion.

Note that exclusion of subjects that do not meet eligibility criteria (i.e. all study inclusion/exclusion criteria) is typically handled already when completing the inclusion/exclusion criteria form, where there will be a designated button for the purpose when saving that form.

To exclude a subject from the study, select ‘Set as Screening Failure’ in the ‘Manage subject’ dropdown menu at the top of the Subject Page (see Subject Page). If the subject is randomized/included, the option is called ‘Early terminate subject’.

The ePRO feature of MediCase eCRF allows subjects to complete questionnaires (or other applicable forms) directly in the eCRF. This may be done either at the clinic or from any computer/tablet with internet access (i.e. from home, etc).

There is always the backup possibility for site staff to enter the questionnaire data into MediCase eCRF if the subject has completed a paper version of the questionnaire (e.g. does not have access to a computer from home, or is otherwise unable to enter data directly into the eCRF).

Each subject has a unique login, and when logging in will only be presented the forms currently applicable for the subject to complete. The subject cannot access any other forms, functions, data, etc.

Refer to the sub-chapters below for various ways to log the subject in, and for how site staff can enter the questionnaire data if needed.

If the study/registry is using an ePRO component (i.e. any questionnaire that the subjects answer themselves directly in MediCase eCRF), you can click ‘Log in as this subject’ in the subject details window to switch to subject mode (i.e. log yourself out, and log in the subject instead). Note that if you yourself want to continue using MediCase eCRF (on the same computer) once the subject is done, you will then need to log yourself in again.

The subject may log in to MediCase eCRF from any computer or device, e.g. from their home or mobile. The login page is the same as for all MediCase users, https://login.medicase.se. The credentials (username and password) for the subject is found in the subject details dialog (see 2.3.1 Subject Details) by clicking “Show subject credentials”.

Show login credentials for the subject in the subject details dialog

By clicking “Print user credentials” you can print a page containing the username and password for the user, to hand as login information to the subject.

If the subject will be answering a questionnaire at the clinic, logged in site staff can easily switch over to subject mode, i.e. log themselves out and instead log in the subject – see Switch to Subject Mode (for ePRO)

Questionnaires/form that are primarily intended to be completed by subjects directly will still appear just like any other form on the Subject Page (see Subject Page), but with ‘Subject enters’ noted to the right (Comments column). If needed (e.g. subject had to complete the questionnaire on paper for some reason) site users may complete the form in the very same way as any other form is completed (see Enter Data).

Monitor may add data queries if suspected errors or inconsistencies are found during monitoring. A query must be resolved before the form at which it has been raised can be closed by the monitor.

To view a list of any queries, click the query icon in the sidebar, or select “Queries” in the navigation menu:

Click the query icon in the menu to view all queries

The list can be filtered using the drop-down selectors just below the list headers at the top of the list.

Notice the Status column. Queries that are still are pending resolution has status=Open, resolved ones has status=Closed.

You may want to user the filtering options in the “Next action” column header. Selecting “Monitor” will display all queries where site staff has answered a monitor question, and the queries are waiting for a monitor to close them, or add another comment. Selecting “Site” will display all queries where site action is required – new monitor queries and queries where the monitor has added the latest comment.

Clicking in the Query column for any listed item will display a window that shows the query details. You may also here add a response to the query (The ‘Enter comment’ field, and clicking the ‘Add comment’ button).

Clicking in the ‘Subject’ column for any listed item will take you to the Subject Page (see Subject Page) where you can access and edit the visit and form that the query regards.

When you view an entered form that has an open (unresolved) query, a query bar will be displayed below the question.

When entering forms, use the “edit” icon in the query panel to view or comment the query

When entering forms in older studies, the interface looks slightly different – questions with queries are marked with  (open query) or  (closed query.)

Clicking the query icon next to a form field will open the query dialog, where you can view details and add comments

You can plan visits directly from the subject page (see Subject Page). You can also plan visits, and view/manage planned visit dates, on the ‘Visits’ page. The Visits page is accessed by clicking ‘Visits’ in the sidebar menu.

The visits page

All known subject visits will be included in the visit list. By selecting ‘Unplanned’ in the ‘Visit status’ column filter, you can choose to only display unplanned visits.

The ‘Date’ column displays the visit date for open visits, planned visit date for planned visits and ‘(Not planned)’ if the visit is not planned. Clicking on the date, or “(Not planned)” where applicable, will allow you to schedule/reschedule the visit date. By using the column filter, you can filter out all upcoming visits tomorrow, the next week, or where the next visit has not yet been planned (and many other options).

If your study uses the ‘Advanced visit planning’ module, visit may have visit windows specified. If so, the visit window for each visit is displayed in the ‘Visit window start’ and ‘Visit window end’ columns. Also these columns can be filtered, so you may e.g. filter out visits where the visit window ends within the next three days.

In the visit planning list, all passed dates are displayed using red text.

Clicking on a row in the ‘Planned date’ column will open a dialog where you can plan, or reschedule, the visit.

Clicking the “Planned date” column opens a dialog where you can plan the selected visit

Electronically signing the eCRF data is equivalent to a handwritten signature in a paper CRF.

You may use the signing batch tool by selecting “Signing” in the top menu, or sign a specific form.

In the batch signing tool, you select the subjects you want to sign. Then click “Continue” and enter your password to sign all forms for the selected subjects that are in “To be signed” state.

The batch signing page

To sign a specific form, open the applicable visit on the subject’s Subject Page (see Subject Page) and click ‘Sign’ for the form you want to sign:

On a subject visit, you can sign each form separately, or sign all forms in the visit with a single signature.

The form will be displayed for review, and at the very bottom there is a field where to enter your password. After entering your password, click the ‘Sign form’ button.

You may also click ‘Sign all forms’ below the form list to sign all forms that are ready to be signed in the displayed visit.

Studies may be configured with different monitoring plans, as per requirements in each study. A plan may call for 100% monitoring of all data, or a risk based approach where only certain subjects/forms/questions are monitored (an example plan might be: full monitoring of all data for the first subject in each treatment group at each site, and then for 20% of the remaining subjects full monitoring and for 80% monitoring of key efficacy/safety data only). MediCase eCRF will select and “randomize” which subjects/items to monitor based on the rules of the plan. The plan is configured by the administrator when the study is set up (i.e. the monitors do not themselves need to do any configuration of the monitoring plans).

MediCase eCRF will select items to monitor based in the plan, and display what is expected to be monitored in the Monitoring work-list (see Monitoring Work List).

It is important to recognize that MediCase eCRF flags items selected for monitoring according to the plan, but the monitor has full freedom to monitor additional (or even less) data than what the plan has called for if she/he finds it appropriate.

It should also be noticed that the site staff will not know/see which subjects/items that are selected for monitoring. The staff will send all forms for monitoring (see Form Flow) unknowingly of whether or not that form is selected for monitoring by MediCase eCRF according to the monitoring plan and if the monitored will in fact monitor the form (or any part of it).

For each form the site staff has sent for monitoring, the monitor will need to decide on one of these options (with the aid from the features described throughout this chapter):

• Skip monitoring (the normal option for forms that do not have any questions that has been selected for monitoring by MediCase eCRF based on the monitoring plan). This will set the form status directly to ‘To be signed’
• Monitor the form (the entire form, or a subset of its’ questions), which may or may not result in queries from the monitor. When any queries (if applicable) have been resolved and the monitor decides that monitoring is completed, the for will be progressed to ‘To be signed’ status by the monitor.

The Monitoring work-list is the main tool for a monitor in MediCase eCRF. To open the Monitoring work-list, click ‘Monitoring’ in the main menu at the top of the screen:

The monitoring page

The list shows all subjects that has any form (i.e. any data) in status ‘To be monitored’ (see Form Flow). Note that subjects for which there are currently no forms in ‘To be monitored’ status will not be displayed (i.e. if the site staff has not yet sent any forms for monitoring for the subject, or if all forms they have sent for monitoring for the subject have already been marked as completed by the monitor, then the subject will not appear in the Monitoring work list).

The list can be filtered using the drop-down filter selectors below each header at the top of the list.

Clicking in the ‘Subjects’ column for any listed subject will bring up a detailed view of items (forms) for that subject that are currently in ‘To be monitored’ status and where MediCase eCRF has selected at least one question for monitoring (see Monitoring Plans).

The monitoring page for a subject

Items to monitor

These items (forms) have questions that have been selected by MediCase eCRF to be monitored. Clicking one of these items will bring up the form in monitoring mode. See Review Forms, Mark Sdv & Add Queries for further details.

Items not to monitor

These items (forms) have no questions selected by MediCase eCRF to be monitored. You may still click an item, which will bring up the options to skip monitoring or to open the form for monitoring anyway.

Skip monitoring for all items not to be monitored

Clicking this button will skip monitoring for all items under the ‘Items not to monitor’ header, and set the status of those items (forms) directly to ‘To be signed’

At the bottom of the Monitoring work-list there is a button ‘Skip monitoring for selected’. This will skip monitoring for the subjects you have marked in the list, and set the status of all forms currently in ‘To be monitored’ status directly to ‘To be signed’, regardless of whether or not those forms have been selected for monitoring by MediCase eCRF based on the monitoring plan.

Click “Skip monitoring for selected” to set all forms in the “To be monitored” status for the selected subjects to monitored (but skipped).

At the bottom of the Monitoring work-list there is a button ‘Skip monitoring for unmonitored forms’. This will skip monitoring for all forms currently in ‘To be monitored’ status and that has not been selected for monitoring based on the monitoring plan.

Click the “Skip monitoring for unmonitored forms” to mark all forms not including in a monitoring as monitored (but skipped)

When you open a form (either by using the features of the Monitoring work-list, see Monitoring Work List, or through the general subject views, see View All Subject Data) you will get different options depending on if that form has any items selected by MediCase eCRF to be monitored according to the monitoring plan. Refer to the two sub-chapters below.

If the form you have opened does not contain any items selected by MediCase eCRF to be monitored, the below screen will be displayed. Here you have the option to skip monitoring (i.e. progressing the page directly to ‘To be signed’ status), or to show the form for monitoring anyway. If you select to show the form, the view shown in Forms With Items to Monitor

Monitoring a form not included in the monitoring plan

Monitoring a form

• ‘Show all variables’ button: This applies to forms where not all questions have been selected for monitoring by MediCase eCRF based on the monitoring plan. Clicking this button will bring up all questions on the form so that you can monitor the entire form and not only the questions selected as per the monitoring plan
• The dropdown menu next to each questions opens a menu where you can view the audit trail (log), and add a query.
• SDV checkboxes: Tick these boxes to mark questions that you have performed Source Data Control (SDV) for. Note that you may tick the checkbox at the very top to mark the boxes for all questions with just one click.
• ‘Save as monitored’ button: By clicking this button you will save the form as monitoring completed, which will progress the status of the form to ‘To be signed’. NOTE: If there is an unresolved query on the form, the form may not be saved as monitored. In this case, you have to close/resolve all open queries, or reject the form back to data entry.
• ‘Skip monitoring’ button: Skip monitoring for the form
• ‘Continue later’ button: Save your current SDV markings, but leave the form as not monitored.

To manage open (unresolved) queries, click ‘Queries’ in the main menu at the top of the screen:

See Answering Queries for further details about how to filter and navigate this view. Notice that when you open a query from this view (clicking in the Query column for any listed item), you will have the option to close the query by clicking the ‘Close query’ button in the window that opens up.

If a form that has previously been monitored is re-opened and edited by the site staff, it then must be resent to monitoring and will again appear in the Monitoring work-list. When the form is opened by the monitor, all values that have been changed since the previous time the form was monitored (set to status ‘To be signed’ by monitor) will be marked with ‘This value is modified after latest monitoring’ to aid the monitor to determine which questions on that form that need to be reviewed again.

The Monitoring work-list is the best tool for finding the items (forms) that you currently need to take action for. However, sometimes it may be necessary to view data that does not currently appear on your Monitoring work-list (because e.g. monitoring has already been completed, or forms that the site staff has not yet sent for monitoring, etc). You may view all subject data, and open any visit/form for general review and/or adding queries, etc, by clicking ‘Subjects’ in the main menu at the top of the screen:

The subject list

See Subject List for how to navigate from here to a particular form at a particular visit for a particular subject (however note that you will not see options to enter/edit data, but instead options relevant to the monitoring – in particular, for forms in ‘To be monitored’ status you will be able to click ‘Monitor’ to open up that form in monitoring mode).

Medical coding is used to standardize entered data for diagnoses and medical substances by selecting medical codes from common dictionaries. There are many dictionaries available, including ICD-10, ATC, and MedDRA. One or several may be available in your study depending on study configuration.

MediCase eCRF has support for selecting codes from medical coding dictionaries. The study can be configured to let codes be selected directly at data entry, or by dedicated medical coders.

If the study allows coding at data entry, a medical code selector is displayed when entering the form.

A medical code selector. The value to be coded is highlighted in yellow when the code selector is focused.

Click the search icon in the code selector to open a code search dialog where you can select the medical code. Read more about searching codes in the Medical code search dialog section.

The search icon opens up a medical code selector

When a medical code is selected, information about the code is displayed in the form. Clicking the code displays detailed information about the code and its location in the coding dictionary.

When a medical code is selected, clicking the code displays detailed information about the code.

When medical coding is to be performed by dedicated medical coders, a new user role will appear for each dictionary to be coded, e.g. Medical Coder for “ATC”. A user manager may then assign this role to users that will perform medical coding in the study.

Medical Coder users have access to a medical coding tool. In this tool, all entered values that are ready to be coded in the study (or in a specific site, if the Medical Coder user role is assigned as a site role) are displayed. The coder may then select code for the entered values, add and manage queries on the values and view already coded values.

The start page in the medical coding tool displays a summary of how many values are waiting to be coded for each medical code source. A study may contain many code sources if codes are to be selected from different coding dictionaries.

In the medical coding tool, you see how many values are ready to code.

When a code source is selected the coding page is displayed, where all values waiting to be coded are listed. For each item in the list, the coder may select the corresponding medical code by clicking the link in the Code column. When codes are selected, they are marked as “To be confirmed” and not yet marked as coded. The coding is confirmed by clicking “Confirm coding” at the bottom of the page. The selected codes are saved in the system even when they are not confirmed, so you can safely leave the coding page at any time to come back later to confirm the coding.

You can filter the coding list by the filter boxes below each column name.

The coding page displays a list of all values waiting to be coded. When codes are selected, they must be confirmed to be marked as coded in the system.

The coding list displays the value to code for each item, e.g. “Substance”. The Code column shows the currently selected code, or Not coded if no code is yet selected.

If no code is selected, clicking the Not coded link in the Code column opens up the code selector where you select the appropriate code for the entered value. Read more about searching codes in the Medical code search dialog section.

Clicking in the “Code” column opens the medical code search dialog

When a medical code is selected, clicking the Code column will show detailed information about the selected code, and buttons to search for a new code, or remove the selected code.

Clicking in the “Code” column when a code is selected opens the medical code information dialog

The Status column shows the current coding status for each item:

• Not coded – No code is yet selected
• To be confirmed – A code is selected, ready to be confirmed by the coder
• Coded – A code is selected and confirmed
• To be recoded – A code is selected, but must be recoded, or re-confirmed
• Query for action – There is an open query on the selected code or the input value that is waiting to be resolved by the coder
• Pending query – There is an open query on the selected code or the input value that is waiting to be resolved by other users.

The Status column is filtered by “(All to act on)” by default, displaying only items that should be coded, or with queries to act on. By selecting “(All)” in the Status filter box, you also see previously coded items.

Clicking on the link in the Code column displays information about the selected code. From this you may also choose to recode the value.

Selecting “(All)” in the status filter displays also previously coded values.

You may add a query to the input, if you require additional information from data entry. Monitor and data managers may also add a query to a selected medical code. Both types of queries are accessed by clicking Queries in the action menu to the right of each item in the coding list.

Click “Queries” in the action menu to view and add queries on entered input or the selected code.

The audit trail for entered input or the selected medical code is accessed by clicking View log in the action menu to the right of each item in the coding list.

Click “View log” in the action menu to view history log for entered input or the selected medical code.

When medical codes are to be selected you use the medical code search dialog. In this dialog you can search for codes by the code, its description or, in some cases, additional information such as medical products on the market containing the medical substance.

On the Search tab, you can search codes in the dictionary by entering a search text. The search result will contain codes that:

• Has a medical code starting with the entered text
• Has a description containing the entered text
• If the dictionary contains additional information (such as medical products containing the substance – available for Swedish ATC dictionary), codes containing the entered text in the additional information are displayed

All codes are displayed in a tree view, including the parent codes of all matches, to help distinguish similar codes. Parent codes included for clarity are grayed out since they are not actual search matches.

Click Select next to each code to select the code, or click the view icon to the right to show detailed information about the code.

On the “Search” tab you perform text searches. Click “Select” to select a code, or the view icon to view details about the code.

On the Browse tab, you can browse the complete coding dictionary by expanding the top levels in the dictionary until you find the appropriate code.

Click Select next to each code to select the code, or click the view icon to the right to show detailed information about the code.

On the “Browse” tab you browse the coding dictionary. Click “Select” to select a code, or the view icon to view details about the code.

On the Suggestions tab, you can review coding suggestions for the entered input, if any suggestions are found. Coding suggestions are based on exact text matches in the dictionary and previously selected coded for the same input in the study.

Click Select next to each code to select the code, or click the view icon to the right to show detailed information about the code.

On the “Suggestions” tab you can see coding suggestions. Click “Select” to select a code, or the view icon to view details about the code.

Pharmacovigilance means detecting, assessing, understanding and preventing adverse effects or any other medicine related problem.

In MediCase eCRF, there is a specific “Vigilance” user role, which can be assigned to users that conduct pharmacovigilance activities in a study.

The most common use for the Vigilance user role in MediCase is to assess serious adverse events (SAE) added in the study.

As a Vigilance user, you will receive an email notification when an SAE is added in the study (depending on study setup). The notification contains a link to the adverse event details (login required). Read more in the SAE and DD Notifications section.

You can browse all adverse events in the study on the “Adverse events” page. Note that this page contains all adverse events, not only SAEs. You may use the filter to show only SAEs.

On the adverse events page, use the “Type” filter to show only SAEs.

From the adverse events page, you can click on an event (in the ‘Subject’ column) to view the entered information about the event.

When viewing an entered adverse event, select “Audit trail” from the dropdown menu to view the audit trail

In medical device studies, Vigilance users may also receive notifications when reportable device deficiencies are added in the study.

As a Vigilance user, you will receive an email notification when an reportable device deficiency is added in the study (depending on study setup). The notification contains a link to the device deficiency details (login required). Read more in the SAE and DD Notifications section.

You can browse all device deficiencies in the study on the “Device deficiencies” page. Note that this page contains all device deficiencies, not only reportable. You may use the filter to show only reportable device deficiencies.

On the device deficiencies page, use the “Reportable” filter to show only reportable device deficiencies.

From the device deficiencies page, you can click on a deficiency (in the ‘Form’ column) to view the entered information about the device deficiency.

When viewing an entered device deficiency, select “Audit trail” from the dropdown menu to view the audit trail

MediCase eCRF has a feature for adding comments, “Notes to file”, about a subject. These comments may be clarifying information regarding why e.g. a study procedure or a study visit was not performed, and can be viewed by site staff and monitor.

To add a note to file, click the ‘Add’ button (as shown in the image below) in the upper right part of the subject’s Subject Page (see Subject Page):

View and add notes to file at the top of the subject page.

On the reports page you can get up-to-date reports from the system. You reach it by clicking the “Reports” icon in the sidebar, or selecting “Reports” in the navigation menu.

On the reports page you may select between a number of reports

Select one of the reports on the page to run that report, using up-to-date data:

The “Statistics” report displays general statistics about study recruitment.

A study can be configured to send email notifications to specific users when a serious adverse event (SAE) is added on a subject. The email message will not contain any sensitive information, but only a link to the entered adverse event. When clicking the link, the user has to login to MediCase eCRF as a user with permission to view the adverse event.

The study can be configured to send SAE notifications to users with specific roles, e.g. vigilance, monitors, sponsors, investigators. Notifications can also be sent to a specific email address (vigilance email address). In this case, the recipient still has to login to MediCase eCRF to view the content of the SAE.

A specific user can always opt-out from receiving SAE notifications in the user’s ‘study profile’. The study profile is accessed from the ‘My study profile’ link on the list of your studies when logging into MediCase, and also from the ‘My study profile’ option in the profile menu (top-right on the page) when logged into a study’s eCRF.

In medical device studies, the study can similarly be configured to send device deficiency notifications when reportable device deficiencies are added to the study. When a reportable device deficiency is added, the notification will be sent to the same users and email addresses configured for ‘SAE notifications’.

A study can be setup to send notifications to subjects view email or SMS text messages. This requires that email addresses and/or phone numbers are collected for subjects (in a separate “personal identifiers” database).

Notifications are setup to be sent a specified number of days before a planned visit (or on the planned visit date). The notification message is customized for the study and visit, and may contain subject user credentials or login link to the ePRO module, and contact information to the site the subject is connected to.

In the sidebar menu, the ‘Search’ function opens up a search dialog where you can quickly search for subjects by their subject and/or screening number, and go to their subject pages.

The ‘Search’ function lets you search for subjects by their subject and/or screening numbers.