study-management.rst

.. _study-create:

Create a study
==============

1.  Click on **Create new study**

2.  Fill in all required fields on the page:

    -   **Name** describes the title of the study you want to create
    -   **Responsible contact person** is the person who can be contacted if
        any questions regarding the study occur
    -   **Principal Investigator** is the lead researcher
    -   **Phone number** and **E-mail-address** are the contact information at
        which the contact person can be reached

3.  Fill in any additional information (you can still do that later)

4.  Click on **Save** to record your progress

Now you can :ref:`find your study <study-search>` in the studies list.


.. _study-sessions:

Set up sessions
---------------

In the **Sessions** tab, you can enter as many test sessions as you like.

-   **Add session**
-   Set up **Start of test sessions** and **End of test sessions**
-   Define general **Session instructions**

.. hint::
    In **Session Instructions** you can inform recruiters on
    conditions/requirements that may be important for or in between sessions.
    For example, recruiters are often asked to ensure a certain time interval
    between session appointments. This would be explained here.

    **Start** and **End of test sessions** allows Castellum to offer an
    approximate overview schedule of all studies in Calendar view at Study
    management.

When adding a test session:

-   Always give the session a **Name** and specify the **Duration of a session
    in minutes** (duration will be used for appointment booking)
-   Additionally, select the **Type** of the session and (if applicable at your
    institute) select a **Ressource**
-   **Additional text for reminder emails** allows you to provide information
    to subjects prior to the actual appointment
-   If your institute uses the external scheduler to schedule appointments, you
    can enable it here  (see :ref:`set-up-external-scheduler`)

For existing sessions a **Delete** button allows you to delete any test session
you created. Click on **Update** to review or edit session details.


.. _study-recruitment-settings:

Set up the recruitment process
------------------------------

Castellum offers three features to restrict which subjects are considered for
your study:

-   Attribute filters
-   Excluded studies
-   Text based inclusion and exclusion criteria

1.  Go to the **Recruitment Settings** tab

2.  By clicking on **General** the **Recruitment text** will be shown to you.
    You can:

    -   edit the **Recruitment text** (this text will be shown to recruiters
        and will be used by them to recruit subjects for your study),
    -   decide whether you wish to set up the **Advanced filtering** (this
        allows you to create multiple filtergroups that are not linked to each
        other),
    -   set the function **Exclusive subjects** (If you select this feature,
        potential subjects for your study cannot be recruited for other
        studies. Please note that this may prevent other researchers from
        finding enough participants.) and
    -   decide whether **Complete filter matches only** will be shown to the
        recruiters of your study or if there will be some subjects displayed,
        in which certain characteristics still have to be queried

3.  By clicking on **Filter** you are able to set filter criteria

    -   select the attribute that should be used for filtering
    -   click **Add**
    -   define the filter
    -   click **Apply**

    You may set as many filters as you like.
    If you wish to create more than one filter group, proceed as follows:

    -   click on **General**,
    -   select **Advanced filtering** and
    -   click on **Save**

    When you click on **Add new** in **Filters**, you are able to set another
    filter group with specific filters

    .. note::
        This is necessary, for example, if you need subjects both at the age between
        20-30 and 50-60.

4.  In **Excluded studies** you can select certain studies in which your
    subjects must not have participated

5.  When you click on **Inclusion/exclusion criteria**, you can add **Additional
    subject characteristics that should be verified during the recruitment**

    .. note::
        If it is a MRI-study, the criteria are pre-set for checking during recruitment

6.  If recruitment is to take place by e-mail, proceed as follows:

    -   click on **Mail Settings**
    -   define an **E-mail subject**
    -   add an **E-mail body**

    .. note::
        It is not intended to send attachments in the first e-mail via Castellum.
        Instead, links can be inserted.


.. _study-members:

Manage study members
--------------------

If you want to give access to a person (e.g. a recruiter) for your study,
please follow the steps below.

1.  Go to the **Member management** tab

2.  If you click on the field under **User**, you will be shown all possible
    users to whom you can assign roles

3.  Select the user who is supposed to take over the recruitment

4.  Click on **Add**

5.  Click **Manage groups** next to the person you have chosen

6.  Select the appropriate roles and click **Save**

    .. note::

        Some features (e.g. recruitment) only become available once the study is started.


.. _study-start:

Start and stop a study
======================

After a study has been created it is still in a draft state. Only Study
Approvers have the permission to start recruitment. Depending on your
organization, there may be different organizational steps such as a review
associated with that.

In order to start or stop a study, a Study Approver needs to follow these
steps:

1.  :ref:`Find the study <study-search>` at the **Studies** page, click
    **Details** next to the study you wish to start/stop

2.  You can find the button **Start** near to the study name. By clicking on
    **Start** you initiate the recruiting process. Started studies will offer a
    stop button instead to stop (or pause) recruitment.


.. _study-finish:

Finish a study
==============

1.  :ref:`Find the study <study-search>` at the **Studies** page, click
    **Details** next to the study you wish to start/stop.

2.  You can find the button **Finish study** next to the study name near to
    other buttons.

.. note::

    All information related to potential subjects that were not invited to the
    study will be deleted when the study is finished. If you finish and then
    resume a study, it is possible that subjects that were already found to be
    unsuitable are proposed again.


.. _study-delete:

Delete a study
==============

When a study should be deleted depends on the rules of your specific
organization. We assume that it makes sense to delete all study data after few
years, effectively anonymizing the research data.

Once you delete a study from Castellum it is no longer possible to answer to
export or delete requests from subjects. Make sure that all relevant external
has been deleted before you delete a study from Castellum. Then proceed as
follows:

1.  :ref:`Find the study <study-search>` at the **Studies** page, click
    **Details**

2.  Make sure the study is finished (see :ref:`study-finish`)

3.  Click on **Delete** under the study name
    -   Confirm the notice **I have made sure that all external data related to
        this study has been destroyed**
    -   Click on **Confirm**


.. _study-search:

Find your study
===============

Click on **Studies** on the front page

-   By selecting **Mine** in **Membership**, you will see studies you created
    or are a member of. Under the field **All** you can see all studies that
    have been created.
-   In the field **Search** you can look for a certain study
-   By choosing a **Status** and / or a Study **Type**, you may also filter
    studies