Create a study
Click on Create new study
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
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.
Fill in any additional information (you can still do that later)
Click on Save to record your progress
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.
Set up Start of test sessions and End of test sessions
Define general Session instructions
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 Resource
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:
Text based inclusion and exclusion criteria
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.
Go to the Recruitment Settings tab
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
By clicking on Filter you are able to set filter criteria
select the attribute that should be used for filtering
define the filter
You may set as many filters as you like.
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.
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.
In Excluded studies you can select certain studies in which your subjects must not have participated
When you click on Inclusion/exclusion criteria, you can add additional subject characteristics that should be verified during the recruitment
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.
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.
It is not intended to send e-mail attachments via Castellum. Instead, links can be inserted as standard text.
Manage study pseudonym domains
In the Pseudonym domains tab you can add a new domain or change the name of an existing domain.
If there are general domains you can also define which general domains need to be accessed in the context of this study.
Manage study members
If you want to give access to other staff members (e.g. recruiters) for your study, please follow the steps below.
Go to the Member management tab
If you click on the field under User, you will be shown all possible users to whom you can assign roles
Select the user who is supposed to take over the recruitment
Click on Add
Click Manage groups next to the person you have chosen
Select the appropriate roles and click Save
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:
Find the study at the Studies page, click Details next to the study you wish to start/stop
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.
A study can still be changed after it has been approved and started. The tab “Changes” provides an overview of all the settings for a study. Any changes that were made since the study was started are highlighted.
Finish a study
Find the study at the Studies page, click Details next to the study you wish to finish/resume.
You can find the button Finish study next to the study name near to other buttons.
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:
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
Check whether the database contains enough subjects for your reasearch project
Click on Studies on the front page and then on Try filters. You can now experiment with filters just as in a regular study. The preview will show you how many subjects in the database match your filters.
If you decide you want to keep the set of filters you can go to Convert to study to convert your temporary settings to a regular study.