study-management.rst

.. _study-create:

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

1.  Click on **Studies** on the front page

    -   By selecting **Mine** in **Membership**, you will see studies you created.
        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

2.  Click on **Create new study**

3.  Fill in all empty fields on the page:

    -   **Name** describes the name or 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
    -   Define the person who is the lead researcher as **Principal Investigator**
    -   Determine all scientists that take part in the study as **Affiliated Scientists**
    -   Determine all research assistants that take part in the study as **Affiliated
        Research Assistants**
    -   **Phone number** and **E-mail-address** are the contact information at
        which the contact person can be reached
    -   Please enter all methods you would like to use in your research in the field
        **Description**
    -   **Keywords** may include main issues of the desired scientific findings
    -   Decide whether the study **Contains sensitive data** or not

4.  Upload templates of **Consent** form(-s) of your study

5.  Assign the **Required number of subjects** to your study

6.  Decide whether it **Is a one time invitation** or not

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

Now you can find your study in the list


.. _study-recruitment-settings:

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

In order to limit the search for subjects in Castellum,

-   filters,
-   excluded studies as well as
-   inclusion and exclusion criteria should be defined.

1.  Go to **Studies** on the front page, click **Details** next to the study
    you wish to set up filters and criteria for

    If you have already started the study, click on **Stop** on the upper left.
    If you did not start it yet, you will be able to edit filters and criteria right away.

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

3.  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

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

    -   select whether you want to create a filter regarding the **First language**,
        **Highest educational degree**, **Handedness**, **Has hearing aid?**, **Age**
        or **Sex**
    -   click **Add**,
    -   define the filter and
    -   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.

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

6.  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

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

   -   Define **Session instructions**,
   -   **Start of test sessions**,
   -   **End of test sessions** and
   -   Click on **Add session**

   -   When adding a test session, always give the session a **Name** and specify
       the **Duration of a session in minutes**
   -   Select the **Type** of the session and press **Add session**
   -   By clicking on the red button **Delete**, you can erase any test session you
       created
   -   Click on **Update** to go to Session details. If your institute uses the
       external scheduler to schedule appointments, you can enable it here
       (see this guide: :ref:`set-up-external-scheduler`)


8.  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.  Click on **Studies** on the front page

2.  Click on **Details** of the study for which you want to change access rights
    or role redistribution

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

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

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

6.  Click on **Add**

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

8.  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 organziational 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.  Go to **Studies** on the front page, click **Details** next to the study
    you wish to start/stop.

2.  You can find the button **Start** in the left upper corner under the study
    name. By clicking on **Start** you initiate the recruiting process


.. _study-finish:

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

1.  Go to **Studies** on the front page, click **Details** next to the study
    you wish to start/stop.

2.  You can find the button **Finish study** in the left upper corner under the study
    name.

.. 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 makes sense to delete all study data after few
years, effecitvely 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. The proceed as
follows:

1.  Go to **Studies** on the front page

2.  Choose the study you want to delete by clicking on **Details** next to it

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**