Subject management

Search for a subject

Screenshot of the subject search view

  1. Click on Subjects on the front page

  2. Enter the first name and surname, the email address, or the phone number

    • If you provide a second first name, you will only find the subject if that name was also entered in the contact data. So if you do not find a subject by full name, also try leaving out second names.

    • Keep the order as indicated

    • No comma needed

  3. Confirm by clicking Search

  4. Under the Matches tab all matching subjects or their legal representatives are listed

    • Next to their name the date of birth is listed and, if provided, also their email address

    • If either parts of their name or their email address are matched exactly by your search terms, this part is highlighted in yellow

    • Details will take you to the subject overview page

    • If a subject has any study participations, they are listed below in this order: name of the study, the name of the responsible contact person and the participation status. The buttons Recruitment and Execution (if the study is still in execution) lead to recruitment and execution for this study. Note that whether you can see study participations is dependent on your permissions

  5. If there is a Match found, confirm that this is the correct person by asking for a second feature (e.g. date of birth).

    Warning

    Only ask for a second feature, do not disclose any information yourself. This is to avoid leaking personal information to imposters.

Create a subject

Subject data is split up into subsets that include at least the following information:

  • First name and Last name

  • Date of birth

  • Information on whether the person is Full of age or has legal representative. If the subject has a legal representative, you will need to Add legal representative (see instructions in Contact Tab)

  • E-mail address and/or Phone number and/or full postal address and/or contacting details of the legal representative

  • Recruitment attributes

  • Interest in study types

  • Privacy level

  • Recruitment Consent given

  • GDPR requests

  • Study Participations

In order to create a potential subject in Castellum, please proceed as follows:

  1. Search for a subject

    1. If there is a Match found, the subject is already created in the database. You may edit or add information to this subject by clicking on Details next to the subject. If it turns out that a Match is a different person with the same name you are free to create a new subject.

    2. If No matches can be found, click on Create. If you notice that you made a spelling mistake with the names, please do not go back and create the person again, but change the name in the following process.

  2. Define the Privacy level

    • 0 (regular) describes adults without extraordinary features

    • 1 (increased) indicates children or adults with a legal representative

    • 2 (high) represents adults (and their children/wards) who for example are public figures

  3. Click on Create new subject

Warning

Recruiters often find themselves in fast paced situations when talking to new potential subjects. Hence, we decided to support a quick creation of subjects. Therefore, a subject is initially created with very basic information on name and privacy level. To assure a viable data set there is much more information you should enter (see Edit Subject Data).

Edit Subject Data

Subject data consists of several subsets represented as tabs. Tabs that lack some important information are highlighted by an icon with an exclamation mark. Below, you’ll find a short description for each tab. Please note that tabs need to be saved upon changes individually.

Screenshot of the subject detail view

Overview Tab

This tab gives you a quick overview of the subject data. Importantly, it offers different legal bases for storing the subject data in Castellum. You can check, add or rather edit the basis that applies.

Contact Tab

This tab allows you to set up common information needed to get into contact with a subject.

  • Optionally you can enter the Title here

  • You can edit the First name and Last name

  • Fill in the Date of birth

  1. If the person is an adult, select Full of age and continue with the following steps:

    • Define at least one of the following contact details: Email, Phone number and/or Postal address

    • You may want to add Additional information for postal address, such as c/o details

  2. If the person is not of an adult age or has a legal representative for example due to a disability or illness, select Has legal representative > Add legal representative

    • A new window will open

    • Fill in the first and last name of the subject’s legal representative > Search

    • If a Match is found, select it

    • If No matches found applies, click Create > Enter necessary information in the fields provided > Create new subject

    Note

    The legal representative is now added. You can also create several legal representatives. By clicking on Remove next to the legal representative’s name, you can delete them as the legal representative of the subject.

Recruitment Attributes Tab

The recruitment attributes tab lists all attributes and interests in study types. Recruitment attributes are features that are used to decide on suitability for a study. It is expected that they only provide indications on suitability as there are usually additional criteria that need to be checked for a study match.

  • Fill in the recruitment attribute fields used at your institute

  • If the person Does not want to participate in the following study types, select one or more

Example

Recruitment attributes may be Mother Tongue, Highest Educational Degree, Age, Handedness and so on.

Clear unnecessary recruitment data

If the subject does not have recruitment consent there is no legal basis for storing any recruitment data. In that case there will be a warning about the unnecessary recruitment data. You can either clear all data manually or use the Delete all button that is included in the warning.

Data Protection Tab

At the data protection tab should be used for to document recruitment consent and GDPR requests.

  • redefine the Privacy level

  • indicate whether the subject has consented to the recruitment (for details see Set Recruitment Consent for a Subject)

  • initiate an Export request

  • specify whether the subject is To be deleted

Additional Info Tab

This tab mainly focusses on when to best reach out to subjects.

  • define the Availability of the subject

    Example

    The person is abroad for 6 months.

    • Select Not available until today in 6 months

  • define which Data source the data comes from

Study Participations Tab

The participations tab is offering to check existing participation or add the current subject to a study

  • Participating: Lists the study participations of this subject

  • Matching Studies: A list of currently active studies with matching filters is displayed. You can add the subject to one or more study recruitments.

  • Add to study: Search for a study and add the subject directly as participating to it.

Mark a subject for deletion

To satisfy GDPR requests for deletion of all data related to a subject, please proceed as follows:

  1. Click on Subjects on the front page

  2. Enter the first name and surname of the subject to be deleted into the search field and click on Search

  3. Click on Details and then go to the Data protection tab

  4. Select the checkbox To be deleted

  5. Click on Save

The subject is now cleared for deletion from the database and deletion of their associated data. The data protection coordinator will take care of final deletion.

Delete a subject

You may want personal data and subjects to be completely deleted because of an explicit request from the subject or simply because there no longer is a sufficient legal basis to keep the data.

In order to delete the externally and internally stored data of a subject, please proceed as follows:

  1. In the subject details, go to the Delete tab

  2. If you see a message saying This subject cannot be deleted because there still is data about them in studies., proceed as follows:

    • Contact the responsible person for each study and ask them to delete all collected data of the subject that is not covered by retention policies. Identify the subject using the study pseudonym that is displayed.

    • Once the responsible contact person has confirmed the deletion of the data, delete the participation record using the Delete button.

  3. If you see a message saying This subject may still have data in general pseudonym lists., proceed as follows:

    • Click on Pseudonyms next to General pseudonym lists to get a list of pseudonyms.

    • Contact the responsible person for each general pseudonym list and make sure that all data is deleted.

  4. Once all participations have been deleted you will see a message saying Are you sure you want to permanently delete this subject and all related data? You can now click Confirm and the subject will be deleted.

Warning

There may still be data stored in a backup. Please check with your local IT department to verify proper deletion.

Note

Deleting a subject who has legal representatives will not automatically delete the corresponding legal representatives. However, if there is no other reason to keep the legal representatives in Castellum, they will appear in the data protection dashboard.

Hint

If you want to double check that the subject really wants to be deleted from the database, you can find the last person who was in contact with them via the Audit Trail.

Report a subject

If you experience inappropriate behavior from a subject and you have reason to believe that this subject should never be invited again to participate in any study, you can file a report which will be sent to the assigned reviewers to handle.

  1. Go to a page for that subject (either in subject management, recruitment, or execution) by following the steps in Search for a subject.

  2. In the header, under the name of the subject, click on report

  3. You have the option to add wishes, regarding the handling of the report, by writing them into the textbox under Additional wishes (optional)

    • For example, if the incident was traumatic and you need additional support, you can write I would like to talk to someone about this incident, or even I would like to talk to someone of my own gender about this incident

  4. To finalize the report, click on Send report

Hint

It is required to configure at least one email address that should receive email notifications about new subject reports and handle them. Please ask your system administrator to setup CASTELLUM_REPORT_NOTIFICATION_TO.

Block a subject

If a subject has been reported for inappropriate behavior, then an email will be sent to the email addresses of the reviewers that are listed in CASTELLUM_REPORT_NOTIFICATION_TO. For privacy reasons, no information except for the link to the report is included in the mail.

After opening the link to the report, a reviewer will be shown:

  • The name of the subject that was reported

  • The name of the user that made the report

  • The additional wishes of the user, if they have provided any

Reviewers can then decide what to do with the report:

  • If they want to block the subject, reviewers can click on Block subject

  • If they don’t want to block the subject, reviewers can click on Discard report

  • In both cases, the report is deleted, for privacy reasons.

Add a subject to a study

Note

Please note that these are instructions on how to add a specific subject to a study. If you have a study and are looking for subjects, please use the recruitment process (Recruit subjects via phone)

There are two similar but different ways to add a subject to a study.

To add a subject to an active study whose filters match the attributes of the subject, proceed as follows:

  1. In the subject details, go to the Study participations tab

  2. Clicking on Matching studies will show a list of studies whose filters match on this subject’s attributes.

  3. Clicking on the button named Contact will take you to this subject’s contact page in the recruitment for the selected study. For further information on how to proceed from there, please see the please see the recruitment guide (starting with point 4).

To add a subject to any study, proceed as follows:

  1. In the subject details, go to the Study participations tab

  2. Under Add to study, enter the name of the study you want to add the subject to.

  3. Clicking on the button named Add to study will set this subject as participating in the study.

Note

Please note that this search doesn’t differentiate between active and finished studies. Matching filters are not checked either. This feature is intended to support migrating from other tools that previously tracked study participations.