Commit 48a0acaf authored by Bengfort's avatar Bengfort
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Gardening

parent 28f29624
Consent Management
===================
Checking the Consent Documents
-------------------------------
There are three options that justify a **Legal basis for data processing**:
- **Recruitment consent** (Art. 6 (1) lit. a, Art. 9 (2) lit. a GDPR)
- **Study consent** (Art. 6 (1) lit. a, Art. 9 (2) lit. a GDPR and Art. 27 BDSG)
- **Guardianship** (Art. 6 (1) lit. a, Art. 9 (2) lit. a GDPR and Art. 1626, 1902
BGB)
- **Recruitment consent** (Art. 6 (1) lit. a, Art. 9 (2) lit. a GDPR)
- **Study consent** (Art. 6 (1) lit. a, Art. 9 (2) lit. a GDPR and Art. 27 BDSG)
- **Guardianship** (Art. 6 (1) lit. a, Art. 9 (2) lit. a GDPR and Art. 1626, 1902
BGB)
Castellum is mainly intended for the management of recruitment consents. Study
consents must be obtained separately from the respective study conducters
1. Log in to Castellum by using your username and password
2. Click on **Admin** on the front page
1. Log in to Castellum by using your username and password
2. Click on **Admin** on the front page
3. Scroll all the way down and click on **Consent documents**
- You will see a list of all consent documents that have been created
- Additional information displayed is the date of creation and whether the
consent document is valid or not
3. Scroll all the way down and click on **Consent documents**
- You will see a list of all consent documents that have been created
- Additional information displayed is the date of creation and whether the
consent document is valid or not
Updating the Consent Documents
-------------------------------
......@@ -29,88 +31,91 @@ Consent documents are marked as invalid if a change in legislation occurs, subst
changes have been made to the old document or other reasons require the signing
of a new document.
1. There are two options you may implement when a consent document becomes invalid
For both options first go to **Admin** on the front page > **Consent documents**
in the last section > click on the date the consent document you want to change
the status for has been created
1.1. The consent form can be marked as **Is deprecated** AND **Is valid**
- **Is deprecated** can be considered as an intermediate step between the
validity and invalidity of a consent document
- with this option, the subjects may remain in the database and may be recruited
but a new consent document should be obtained soon
1.2. If you uncheck the box saying **Is valid** but leave the check in the box stating
**Is deprecated**, the consent document is generally marked as no longer valid
- If the invalidity of the consent is saved, there is no longer consent for
the recruitment of a subject in the database
This does not apply when the **Legal basis for data processing** is a **Study
consent** or **Guardianship**.
You can see the legal basis for data processing for each subject individually by
following the instructions below:
- Click on **Subjects** on the front page
- Type in the first and last name of the subject and click on **Submit**
- Click on **details** next to the subject
- In the tab **Overview** you can see the three possibilities for consent and
which of them apply to the respective subject
2. If you wish to upload a consent document that is currently valid, proceed as
follows:
- Click on **Admin** on the front page
- Scroll down and click on **Consent documents**
- Click **ADD CONSENT DOCUMENT** (grey oval on the upper right)
- Select a file
- Choose one of the three saving options
1. There are two options you may implement when a consent document becomes invalid
For both options first go to **Admin** on the front page > **Consent documents**
in the last section > click on the date the consent document you want to change
the status for has been created
1. The consent form can be marked as **Is deprecated** AND **Is valid**
- **Is deprecated** can be considered as an intermediate step between the
validity and invalidity of a consent document
- with this option, the subjects may remain in the database and may be recruited
but a new consent document should be obtained soon
2. If you uncheck the box saying **Is valid** but leave the check in the box stating
**Is deprecated**, the consent document is generally marked as no longer valid
- If the invalidity of the consent is saved, there is no longer consent for
the recruitment of a subject in the database
This does not apply when the **Legal basis for data processing** is a **Study
consent** or **Guardianship**.
You can see the legal basis for data processing for each subject individually by
following the instructions below:
- Click on **Subjects** on the front page
- Type in the first and last name of the subject and click on **Submit**
- Click on **details** next to the subject
- In the tab **Overview** you can see the three possibilities for consent and
which of them apply to the respective subject
2. If you wish to upload a consent document that is currently valid, proceed as
follows:
- Click on **Admin** on the front page
- Scroll down and click on **Consent documents**
- Click **ADD CONSENT DOCUMENT** (grey oval on the upper right)
- Select a file
- Choose one of the three saving options
Deletion of a Consent Document
------------------------------
1. Click on **Admin** on the front page
2. Scroll down and click on **Consent documents**
3. Click on the consent document to be deleted
4. Click on **Delete**
5. Confirm the question regarding the deletion of the consent document by clicking
**Yes, I'm sure**
1. Click on **Admin** on the front page
2. Scroll down and click on **Consent documents**
3. Click on the consent document to be deleted
4. Click on **Delete**
5. Confirm the question regarding the deletion of the consent document by clicking
**Yes, I'm sure**
Maintenance of Recruitment Consents
------------------------------------
In order to get an overview of all subjects for whom a new recruiting consent is
required, proceed as follows:
1. Click on **Subjects** on the front page
1. Click on **Subjects** on the front page
2. Go to **Maintenance**
2. Go to **Maintenance**
3. Click on the fourth tab **Consent**
3. Click on the fourth tab **Consent**
- You can see which **subjects have an outdated consent** in a list
- You can see which **subjects have an outdated consent** in a list
4. Click on **Details** next to **Last updated on: XY**
4. Click on **Details** next to **Last updated on: XY**
- A new tab will open for each subject for whom consent is deprecated or invalid
- A new tab will open for each subject for whom consent is deprecated or invalid
5. Go to **Data protection** (fourth tab)
5. Go to **Data protection** (fourth tab)
- If you see an orange description field that says **The current consent refers
to an outdated document and will soon expire, thus rendering the recruitment
consent invalid. Please contact this subject and ask them to consent to the
latest document or withdraw their consent. This message will disappear once
you change the value of the checkbox.**, proceed with steps 6-7
- If you see an orange description field that says **The current consent refers
to an outdated document and will soon expire, thus rendering the recruitment
consent invalid. Please contact this subject and ask them to consent to the
latest document or withdraw their consent. This message will disappear once
you change the value of the checkbox.**, proceed with steps 6-7
6. Obtain valid consent for recruitment either online, by telephone or postal
- As an intermediate step, check the box **Recruitment consent** once
7. If the subject consents to the latest document or withdraws its consent, that
has to be marked
6. Obtain valid consent for recruitment either online, by telephone or postal
- If the subject consents to the latest document: Press **Confirm** in the box
**Recruitment consent** and press **Save**
- If the subject requests GDPR deletion, check the box **To be deleted** and
press **Save**
- As an intermediate step, check the box **Recruitment consent** once
7. If the subject consents to the latest document or withdraws its consent, that
has to be marked
- If the subject consents to the latest document: Press **Confirm** in the box
**Recruitment consent** and press **Save**
- If the subject requests GDPR deletion, check the box **To be deleted** and
press **Save**
......@@ -31,16 +31,16 @@ please proceed as follows:
4. Click on **Delete** on the upper right
4.1. When you see a message saying **Are you sure you want to permanently delete this subject and all related data?**, click on **Confirm** and the subject will be deleted
1. When you see a message saying **Are you sure you want to permanently delete this subject and all related data?**, click on **Confirm** and the subject will be deleted
4.2. If you see a message saying **This subject cannot be deleted because there still is data about them in studies.**, proceed as follows:
2. If you see a message saying **This subject cannot be deleted because there still is data about them in studies.**, proceed as follows:
- Go to the responsible person of the study
- Ask the responsible person to delete all collected data of the subject concerned
- You can find the responsible person by clicking on **Study details** next to
the study name the subject participated in
- Delete all of these study participations by clicking on **Delete** next to
**Study details**
- Go to the responsible person of the study
- Ask the responsible person to delete all collected data of the subject concerned
- You can find the responsible person by clicking on **Study details** next to
the study name the subject participated in
- Delete all of these study participations by clicking on **Delete** next to
**Study details**
Data Maintenance: Deleting a study from Castellum
=================================================
......@@ -51,10 +51,10 @@ Prerequisite
A study should be completely deleted because of one or more of the following
reasons:
- The study is no longer current because it was completed five years or
more ago.
- The study must be discontinued permanently.
- ...
- The study is no longer current because it was completed five years or
more ago.
- The study must be discontinued permanently.
- ...
Before you delete the study, make sure all external data from Castellum is deleted
......@@ -69,14 +69,14 @@ Deleting the study
4. Before clicking on **Delete**, proceed as follows:
- Go to the responsible person of the study and ask them to delete all
collected subject data of the study you want to delete
- You can detect the name of the responsible person in the upper corner under
the study name
- Go to the responsible person of the study and ask them to delete all
collected subject data of the study you want to delete
- You can detect the name of the responsible person in the upper corner under
the study name
5. If all data has been deleted by the responsible person of the study, 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**
\ No newline at end of file
- Confirm the notice **I have made sure that all external data related to
this study has been destroyed**
- Click on **Confirm**
\ No newline at end of file
Study Coordination: Creating a new study
========================================
1. Log in to Castellum by using your username and password
Make sure you are connected to the internet and use your right username and
password
1. Log in to Castellum by using your username and password
2. Click on **Studies** on the front page
Make sure you are connected to the internet and use your right username and
password
- 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 **Studies** on the front page
3. Click on **Create new study**
- 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
4. Fill in all empty fields on the page:
3. Click on **Create new study**
- **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. Fill in all empty fields on the page:
5. Upload templates of **Consent** form(-s) of your study
- **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
6. Assign the **Required number of subjects** to your study
5. Upload templates of **Consent** form(-s) of your study
7. Decide whether it **Is a one time invitation** or not
6. Assign the **Required number of subjects** to your study
8. Click on **Save** to record your progress
7. Decide whether it **Is a one time invitation** or not
8. Click on **Save** to record your progress
Now you can find your study in the list
......@@ -44,12 +43,11 @@ 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.
- 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
......@@ -62,40 +60,40 @@ In order to limit the search for subjects in Castellum,
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
- 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**
- 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**
- 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.
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
......@@ -104,33 +102,33 @@ In order to limit the search for subjects in Castellum,
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
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**
- 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
- 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**
- 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.
It is not intended to send attachments in the first e-mail via Castellum.
Instead, links can be inserted.
Start and finish your study
......@@ -144,11 +142,11 @@ not been initiated yet either.
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
- 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**
......@@ -193,8 +191,8 @@ for your study, please follow the steps below.
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.
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
......@@ -205,14 +203,14 @@ 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**
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**.
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**,
......
......@@ -5,11 +5,11 @@ Recruitment of participants for a study
Make sure you are connected to the internet and use your right username and
password
2. Click on **Studies** on the front page
- When you click on **All** in **Membership** and **Execution** in the field
**Status**, you will be shown a list with studies for which you should recruit
- When you click on **All** in **Membership** and **Execution** in the field
**Status**, you will be shown a list with studies for which you should recruit
3. Click on **Recruitment** next to the study you want to recruit subjects for
......@@ -17,41 +17,41 @@ Recruitment of participants for a study
5. Press the **Contact** button to contact the person you want to reach
- **Email**, **Phone number**, a potential **Phone number alternative**
and / or the **Address** will be shown to you in the tab **Contacting details**.
.. note::
Compare the data in the "Contact" and "Attributes" tabs for each telephone
contact for completeness and timeliness.
- You might also see the **Preferred contact method**, if the person is
**Currently available** and some **General recruiting notes**
- Please have a look at the **Talking points** that the study coordinator has
defined
- **Email**, **Phone number**, a potential **Phone number alternative**
and / or the **Address** will be shown to you in the tab **Contacting details**.
.. note::
Compare the data in the "Contact" and "Attributes" tabs for each telephone
contact for completeness and timeliness.
- You might also see the **Preferred contact method**, if the person is
**Currently available** and some **General recruiting notes**
- Please have a look at the **Talking points** that the study coordinator has
defined
6. Contact the potential subject using the specified method
7. When you received a response from the potential subject, select a **Status
of participation**
- Choose between:
- Choose between:
a) **not reached**
a) **not reached**
b) **unsuitable**
(This may apply if attributes of the person do not comply with the
requirements of the study)
b) **unsuitable**
(This may apply if attributes of the person do not comply with the
requirements of the study)
c) **invited**
(Please note the appointment in the calendar)
c) **invited**
(Please note the appointment in the calendar)
d) **follow-up scheduled**
(Determine the date and time of the recall appointment below)
d) **follow-up scheduled**
(Determine the date and time of the recall appointment below)
e) **awaiting response**
(This may apply if you left a message on the answering machine. If you
sent an e-mail to the person, this **Status of participation** will be
determined automatically.)
e) **awaiting response**
(This may apply if you left a message on the answering machine. If you
sent an e-mail to the person, this **Status of participation** will be
determined automatically.)
- Click on **Save** when you selected the **Status of participant**
......@@ -61,29 +61,30 @@ Editing contact data, attributes and information
If you wish to edit contact data, attributes and information of a subject,
proceed as follows:
- Click on **Contact** next to the subject in the area **Recruitment**
- Click on **Contact** next to the subject in the area **Recruitment**
- Select what kind of information you would like to edit by clicking on
- Select what kind of information you would like to edit by clicking on
1. **Edit contact data**,
2. **Edit attributes**,
3. **Edit data protection** or
4. **Edit additional info**
1. **Edit contact data**,
2. **Edit attributes**,
3. **Edit data protection** or
4. **Edit additional info**
- Make the necessary modifications and click on **Save** once before leaving
the page
- Make the necessary modifications and click on **Save** once before leaving
the page
Approve subjects for deletion
------------------------------
You may want personal data and subjects to be completely deleted because of one
or more of the following reasons:
- the subjects either requested it,
- it no longer makes sense to keep them in the database,
- he or she cannot be reached due to incorrect or missing contact data or
- there is no consent.
The consent may be based on **Recruitment consent**, **Study consent** and/
or **Guardianship**.
- the subjects either requested it,
- it no longer makes sense to keep them in the database,
- he or she cannot be reached due to incorrect or missing contact data or
- there is no consent.
The consent may be based on **Recruitment consent**, **Study consent** and/
or **Guardianship**.
To delete the data and the subject, please proceed as follows:
......@@ -102,8 +103,8 @@ To delete the data and the subject, please proceed as follows:
5. Select the checkbox **To be deleted**
.. note::
The subject is now cleared for deletion from the database and deletion of
their associated data. The data protection officer will take care of final
deletion
Please note that there may still be data stored in the backup even though
the person was deleted from Castellum
\ No newline at end of file
The subject is now cleared for deletion