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:

  • Internet Explorer (version 11 or later) / Edge
  • Firefox
  • Chrome
  • Safari

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.

Screenshot of the user portal

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.

Menu with "2-Step Verification" option

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

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.

Login with SMS method

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.

Login with Authenticator app method

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.

Login with Smart Card method

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.

Link to login options

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”.

Link to reset of 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.

System (SYS) All access to everything in your study
Sponsor (SP) Read-only access
Data Manager (DM) Read-access, and write-access to subject data. Can also lock and unlock data fields for verification purposes
Institutional Review Board (IRB) Read-only access. Can export data sets marked for IRB/MON
Monitor (MON) Read-only access to data, and access to the monitoring features of MediCase eCRF
User Manager (UM) Can assign these user roles to users
Principal Investigator (PI) Write and sign access to data at all sites
Local Investigator (LI) Write and sign access to data at own site
Data Entry User (DEU) Read and write access, but not sign access
Form Entry User (FEU) Read and write access to certain data entry forms, but none or read-only access (as configured) to the remaining forms
Subject User (SU) Write access to subject data
Form Designer (FD) Can design forms for a study
Study Designer (SD) Can design and edit most settings for a study
Super Study Designer (SD+) Can design anything within a study

1.7.Demo

MediCase eCRF has a demo mode, allowing users to safely learn how to use the system or to try things out without interfering with live data.
To access demo mode, press the Demo mode button in the upper right corner, just under your username.

demoButton

When in demo mode, there is a red border 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 top border, as shown below.

demoMode
As it says in the border, 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.Study 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

By selecting ‘Subjects’ from the main menu at the top of the screen, a subject list will be displayed. You will only see subjects from the site(s) to which your user account has access.

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 􀃓ow. 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:

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.


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

2.3.1.1 Edit

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 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.

2.3.1.1.Edit

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 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.

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.

open-visit

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’ 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.

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)

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. You do this by clicking the comment-values icon in the right margin, select the option ‘Omit the value and leave a comment’, and enter a comment explaining why the value is missing. The icon will change appearance to missing-values when a value has been omitted, and MediCase eCRF will accept this as a given response to the question and will not produce an “empty mandatory field” error.

2.3.3.3.Comment Values

If you want to enter a free text comment regarding an entered value, click the comment-values icon in the right margin, and select the option ‘Enter the value with a comment’ and enter your comment. The icon will change appearance to comment-values2 when a value with comment has been entered.

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)

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.

save-and-continue-paging-1

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

save-and-continue-paging-2

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.

 

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 AE, select the “Adverse events” box in the “Additional forms” section. Click the “Add adverse event” link.

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.

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):

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):

2.3.3.9.View Audit Trail

To view the audit trail, open a form in either entry/edit or view mode (see 2.5 ENTER DATA or 2.9 VIEW DATA). On the open form, click the view-audit-trail symbol to the right of each question on the form to display the audit trail for that question.

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):

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):

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 details

Under ‘Login information’ in the Subject Details window (see 2.3.1 Subject Details) site staff is able to see the subject’s unique login details. A subject log in using the link to the study eCRF (i.e. go to the very same login page as all study staff users), and entering the unique username and password.

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 ‘Queries’ in the main menu:

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 alter filtering on the ‘Action required’ and ‘Waiting for comment’ using the filter function under the ‘Latest comment’ header. ‘Action required’ will display all queries where site action is required, and ‘Waiting for comment’ will show those where site staff has responded and the item is awaiting monitor to accept the query response (or again return the query with request for additional action/responses).

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 open a 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:

answering-queries2

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.

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:

All subjects that has any further visit (after the currently last open visit – see 2.4 OPEN VISIT) in the visit schedule will be listed, with some basic information including the next visit (i.e. the visit after that one that was last opened) and the date that visit is planned (or ‘Not planned’ if no date has yet been planned). From here you can filter the list. You can e.g. filter out all upcoming visits in the next week, or where the next visit has not yet been planned (use the filter option of the ‘Date planned’ column).

Clicking on a date, or ‘(Not planned)’ where applicable, in the ‘Date planned’ column will allow you to schedule/reschedule that visit date.

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.

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:

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):

notes-to-file

8.2.Statistics

To view basic recruitment statistics, click ‘Statistics’ in the main menu at the top of the screen:

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 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).

monitoring-items

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.

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 by MediCase eCRF based on the monitoring plan.

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

forms-with-no-items-to-monitor

9.1.2.4.2.Forms With Items to Monitor

forms-with-items-to-monitor

  • ‘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:

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:

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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