study-creation.rst

.. _study-create:

Study Coordination: Creating a new 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**
    -   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


Setting 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.  Click on **Recruitment Settings** on the upper right

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


8.  If recruitment is to take place by e-mail or if information is to be sent by
    e-mail in addition to telephone contact, proceed as follows:

    -   click on **Mail Settings**,
    -   define an **E-mail subject**,
    -   add an **E-mail body** and
    -   indicate a **Reply e-mail-address**

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


Start and finish your study
---------------------------

When you created a study, it has not yet started and the recruiting process has
not been initiated yet either.

1.  Go to **Details** next to the study you want to start or finish

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
    -   In this mode, you will not able to change any characteristics or talking
        points that are needed for recruitment
    -   When you click on **Stop**, you can edit information needed for the
        recruiting process

    In order to approve the persons who are supposed to carry out the recruitment
    process, follow the steps in the explanation **Share studies with your recruiters**
    (see next instruction)

3.  When you click on **Finish study**, Castellum will register your study as
    completed and the recruitment process is stopped

Share studies with your recruiters
----------------------------------

If you want to give access to a person who is supposed to recruit participants
for your study, please follow the steps below.

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

    You will see a list of the studies you have created by clicking on **Mine**
    in **Membership**

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

3.  Go to **Member management**

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 **Recruiter** and click on **Save**

    If you did not start the study yet, the selected person has still no
    access to the study, unless you click on **Start** on the upper left side

    .. note::
        The study is now in progress and the recruiter has now access to the study
        and can begin to recruit. Of course, you may select several persons as recruiters.


Assign access rights and allocate roles
---------------------------------------

To delegate roles amongst different people, proceed as follows:

1.  Follow steps 1-5 of the section **Share studies with your recruiters** above

2.  Select the user for whom you want to change access rights and/or roles and
    click **Add**

    .. note::
        Some users are already assigned to certain global roles in advance.
        This can be recognized by the fact that the role description is highlighted
        in grey.
        Roles with blue background can be flexibly defined and changed by the **Study
        coordinator**.

3.  After clicking **Manage groups** next to the selected person, you can assign
    up to six different roles for the specific study: **Study coordinator**,
    **Subject manager**, **Recruiter**, **Study conductor**, **Data protection
    coordinator** and **Receptionist**

4.  Select the role you want to assign to the selected person and click on **Save**