1.Introduction

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 1.4 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.

1.1.Supported Web Browsers

MediCase eCRF supports most common modern web browsers:

  • Chrome
  • Firefox
  • Safari
  • Edge
  • Internet Explorer (version 11 or later)
  • Modern mobile devices

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

1.2.User Support

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.

1.3.User Accounts

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.

IMPORTANT!

User accounts are strictly personal. Actions and data entries/edits performed under a user session are logged, with personal accountability to the individual the user account belongs to (this is commonly referred to as the “audit trail”). You should never lend your user account to somebody else. Always change your password immediately if you suspect it might have become known to someone else.

1.4.2-Step Verification

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

All users may activate 2-step verification for their accounts, but a study may also be setup to require 2-step verification for all users logging into the eCRF. In this way, as a study owner, you can ensure that all users use 2-step verification. Contact us at MediCase if you want to require 2-step verification for your study.
The requirement for 2-step verification does not apply to subjects who log into the ePRO function. Subjects can still log in with username and password, 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.

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”.

1.5.User Roles

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.

Normal user roles (assigned by user managers)
Coordinating Investigator CI The coordinating investigator in a multi-site study, or the principal investigator in a single-site study. Read, write and sign access to data at all sites, and access to the signing tool. Write access only to personal identifiers.
Data Entry User DEU Read and write access to subject data (write access only to personal identifiers).
Data Manager DM Read and export access to subject data. Can also lock and unlock data fields for verification purposes.
Form Entry User FEU Read and write access to certain specified forms only, but no access to other forms.
Institutional Review Board IRB Read-only access. Can export data specialized data sets marked as IRB/MON data sets.
Local Investigator LI Site investigator, in a multi-site study. Read, write and sign access to data at the specified site, and access to the signing tool.
Monitor MON Read and monitor access to data, and access to the monitoring tool.
Personal Identifier Viewer PIV Read access to pesonal identifiers (full name, personal identification number, email address, phone number) entered for subjects.
Sponsor SP The study sponsor. Read access to all sites.
User Manager UM Can assign all user roles (except PIV and UM-PI) to users.
User Manager (data entry roles) UM-DE Can assign data entry user roles only (DEU, FEU and UM-DE) to users.
User Manager (personal identifiers roles) UM-PI Can assign personal identifier roles only (PIV, UM-PI) to users.
Special user roles (automatically assigned or assigned by MediCase)
Subject User SU When using ePRO, a user is created for each subject with this role. The user roles gives write access to the subject’s ePRO forms.
Form Designer FD Can design forms for a study
Study Designer SD Can design and edit most settings for a study
System Study Designer SSD User role assigned to MediCase staff responsible for designing the study.

1.5.1.Assigning User Roles

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.

The “Edit user roles” page

On the “Edit user roles” page, follow these steps to assign roles to a user:

  1. Select the scope of the user role. Choose “Study role” if you want to grant permissions for all study sites. Select one of the study sites if you want to grant permissions for a specific site only.
  2. Select the user role you want to assign.
  3. Click “Add role” to add the selected user role to the user.
    Repeat 1-3 if you want to assign more than one user role.
    NB! You have to click “Save” in order for the changes to be saved.
  4. Click “Save” to save the changes.

1.7.Demo Mode

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.

1.8.Data Flow

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

1.8.1.Subject Stages

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.

1.8.2.Form Flow

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 speci?c step. Data entry is always the ?rst 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.

1.8.3.Visit Progress Status

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”

2.Data Collection

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

2.1.Subject List

Access the subject list using the subjects icon in the sidebar

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

2.2.Adding New Subject

Click the ‘Add a new subject’ at the bottom of the Subject List page (see 2.1 SUBJECT LIST). Enter the basic information that you are prompted for about the subject, and click Save.

2.3.Subject Page

Clicking a subject in the Subjects List (see 2.1 SUBJECT LIST), will open that subjects home page. An example of which is shown below:

The subject page

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 2.4 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.

2.3.1.Subject Details

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

Click “View subject details” on the subject page to view more details

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

The subject details dialog

2.3.1.1.Edit Subject Details

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

2.3.1.2.Switch to Subject Mode (for ePRO)

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 then 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.

2.3.2.Open Visit

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 2.3 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.

2.3.3.Enter Data

In order to enter data, first go to the subject’s Subject Page (see 2.3 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 2.4 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 2.5.1 Save & Continue Later).

2.3.3.1.Errors & Warnings

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 save with ‘Entered’ status (see 1.7.2 Form Flow, and 2.5.3 Save & Continue Later).

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

2.3.3.2.Missing Values (Omit)

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 (comment-values) in the right margin. When omitted, the icon will be colored red (missing-values).

2.3.3.3.Comment Values

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 (comment-values) in the right margin. When a comment is added, the icon will change to a comment icon (comment-values2).

2.3.3.4.Save & Continue Later

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 2.5.1 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 ‘Entering’ status (see 1.7.2 Form Flow)

Save and continue buttons when entering a form

2.3.3.5.Multi-paged forms

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

2.3.3.6.Adverse Events (AE)

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

2.3.3.7.Edit Data

A form that is saved using the ‘Continue later’ button will remain in status ‘Entering’ and can be edited using the ‘Enter’ link (see 2.5 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.

NOTE! Depending on the form status and study setup your user role may not have permission to re-open the form. Investigator user roles have higher permissions to re-open forms than what data entry user roles have.

NOTE! Re-opening a form will require it to be sent back for monitoring (if a study that utilizes the monitoring feature of MediCase eCRF), and/or (if the form already had been signed) be signed again.

To re-open a form, click ‘Reopen’ for the form you want to edit on the Subject Page (see 2.3 SUBJECT PAGE):

Reopen an entered form

2.3.3.8.View Data

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

2.3.3.9.View Audit Trail

To view the audit trail for a value entered in a form, open a form in either entry/edit or view mode (see 2.5 ENTER DATA or 2.9 VIEW DATA). Depending on the form page you are using, you view the audit trail by clicking the view-audit-trail icon to the right of the form field, or selecting “View log” in the form field action menu.

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

3.Include/Exclude & Randomize

3.1.Include Subject

NOTE! This chapter does not apply to most registries, and does not apply to randomized studies where randomization occurs in direct association with the inclusion into the study

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).
  • All visits that occur prior to inclusion into the study in the visit schedule must have been ended (see 10END VISIT)

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 2.3 SUBJECT PAGE):

Including a subject, when subject groups are assigned automatically

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.

3.2.Randomization

Note! This chapter applies only to studies using the MediCase eCRF randomization feature.

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 2.3 SUBJECT PAGE):

Including a subject when randomization is used

Click the ‘Include 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 2.1 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.

3.3.Exclude Subject

A subject can be excluded, before or after randomization/inclusion.

Note! Exclusion of randomized/included subjects should only be done as permitted by, and in accordance with, the study protocol!

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, click the ‘Exclude subject’ button found at the bottom right of the Subject Page (see 2.3 SUBJECT PAGE).

4.Subject Questionnairies (ePRO)

Note! This chapter only applies to studies that has some ePRO component (i.e. any questionnaire that the subjects answer themselves directly in MediCase eCRF)

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 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.

4.1.Subject Login

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.

4.2.Log in by clinic staff

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 2.3.1.2 Switch to Subject Mode (for ePRO)

4.3.Enter By Clinic Staff

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 2.3 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 2.5 ENTER DATA).

5.Answering Queries

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 to view a list of 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 “Data entry user” 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 2.3 SUBJECT PAGE) where you can access and edit the visit and form that the query regards.

When you view and entered form that has an open (unresolved) query, the question that the query regards will have a ans-que-icon-no symbol in the right margin:

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

A question that has a now closed (resolved) query will have the symbol ans-que-icon-yes.

Clicking any of these symbols (ans-que-icon-no or ans-que-icon-yes) will enable you to view the query history.

When entering a form, in newer studies, the interface looks slightly different.

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

6.Visit Planning

You can plan visits directly from the subject page (see 2.3. SUBJECT PAGE). You can also plan visits, and view/manage planned visit dates, in the Visit Planning module. The Visit Planning module is accessed by clicking ‘Subjects’ on the main menu, and the on ‘Visit planning’ in the sub menu that appears below the main menu:

The visit planning page

All subject visits that are not opened will be included in the visit planning list). By default, only visits that are the subjects’ next visit (i.e. the visit after that one that was last opened) will be listed. This can be changed in the drop down filter in the “Visit” column.

The “Planned date” column displays the planned visit date, or “(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 dialog where you can plan, or reschedule, the visit.

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

7.Signing Data

Note! This chapter applies to investigator user roles, that have the permission to electronically sign the eCRF data. No other user roles has this permission.

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 2.3 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.

8.Miscellaneous

8.1.Notes to File

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 2.3 SUBJECT PAGE):

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

8.2.Reports

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 get run that report, using up-to-date data:

The “Statistics” report displays general statistics about study recruitment

9.Monitoring

Note! This chapter is intended for the Monitor user role only, and applies to studies that utilize the monitoring feature of MediCase eCRF

 

9.1.Monitoring Plans

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 9.2 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.

9.1.1.Skip or Perform Monitoring

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 1.7.2 Form Flow and 2.7 SEND TO MONITOR) 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.

9.1.2.Monitoring Work-List

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 1.7.2 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.

9.1.2.1.Monitor Items in the Monitoring Work-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 9.1 MONITORING PLANS).

The monitoring page for a subject

9.2.1.1 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 9.3 REVIEW FORMS, MARK SDV & ADD QUERIES for further details.

9.2.1.2 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.

9.2.1.3 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’

9.1.2.2.Skip Monitoring for Selected

Note! This option should be used with care!

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

9.1.2.3.Skip Monitoring for Unmonitored Forms

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)

9.1.2.4.Review Forms, Mark Sdv & Add Queries

When you open a form (either by using the features of the Monitoring work-list, see 9.2 MONITORING WORK-LIST, or through the general subject views, see 9.6 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.

9.1.2.4.1.Forms with no items to monitor

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 9.3.2 Forms with items to monitor

Monitoring a form not included in the monitoring plan

9.1.2.4.2.Forms With Items to Monitor

Monitoring a form

  • ‘Show complete form’ 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
  • ‘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: Above this button there is a green checkmark when monitoring of the form can be completed. There may be an error message shown instead, e.g. if there is an unresolved query on the form, preventing monitoring from being completed.
  • ‘Skip monitoring’ button: Skip monitoring for the form
  • forms-with-items-to-monitor-icon-clock icon: Will display the audit trail for the current question
  • forms-with-items-to-monitor-icon-plus icon: Click this icon to add a query for the current question
  • 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.

9.1.2.4.3.Managing & Closing Queries

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

The query list

See 5 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.

9.1.2.4.4.Re-Monitor Re-Opened Forms

If a form that has previously been monitored is re-opened and edited by the site staff, it then must be re-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.

9.1.2.4.5.View All Subject Data

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 2.1 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).

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