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. Decide on setting it up as a regular study that includes study recruitment and execution or as a one time invitation. The option Is a one time invitation should only be used when you are sure that it is sufficient to invite potential subjects anonymously via mail.

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

  5. Click on Save to record your progress

Warning

When choosing option Is a one time invitation: Please be aware that Castellum will not track actual participations or appointments and it will not provide pseudonyms within the study.

Now you can find your study in the studies list.

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

Note

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. You can send yourself a test mail to check the appearance of session reminders by using the corresponding button

  • If your institute uses the external scheduler to schedule appointments, you can enable it here (see Set up an external scheduler for appointments)

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

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

Note

At first it may be unclear how to distinguish attribute filters and inclusion/exclusion criteria:

  • Attribute filters are applied to subject attributes stored in Castellum. In other words, this will only suggest matching potential subjects in recruitment.

  • Inclusion and exclusion criteria need to be used when there is no data available about it in Castellum. Therefore, they must be checked by a staff member explicitly during recruitment.

  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.

    Note

    Please note that all filter criteria set up within this filter group have to be fulfilled. This also means that opposing filters would result in an empty set.

    Sometimes you need to define more than one mutually exclusive group of suitable subjects. For this, you have to set up advanced filtering in general recruitment settings to create various filter groups.

    Subsequently, when you click on Add new in Filters, you are able to set another filter group with specific filters. Alternatively, you could duplicate an existing filter group and edit it afterwards.

    Example

    This is necessary if you need subjects both at the age between 20-30 and 50-60. Again, note the distinction between Any of these and All of these.

  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

    Session types may come with specific criteria that have to be checked every time before appointing subjects to a session. In this case, you’ll see a caret with a label Criteria for: <type> next to the text field. Clicking on it will show you the text that is always appended. In other words: You don’t have to write this type specific text by yourself.

  6. To allow recruiters to send batch invitations via e-mail, proceed as follows:

    • click on Mail Settings

    • define an E-mail subject

    • add an E-mail body

    This e-mail will be sent by recruiters at study recruitment by specifying the amount of recipients. Yet, you can check the appearance of the set up mail by sending a test mail to yourself with corresponding button.

    Note

    It is not intended to send e-mail attachments via Castellum. Instead, links can be inserted as standard text.

Manage study members

If you want to give access to other staff members (e.g. recruiters) 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. So, some added users may not instantly notice those role changes.

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. Find the study 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.

Finish a study

  1. Find the study at the Studies page, click Details next to the study you wish to finish/resume.

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

Note

All information related to potential subjects who were not participating in the study will be deleted when the study is finished. Hence, if you finish and then resume a study, it is possible that subjects that were already found to be unsuitable are suggested again as potential subjects.

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. Find the study at the Studies page, click Details

  2. Make sure the study is finished (see Finish a study)

  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 by clicking on Confirm

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