diff --git a/Makefile b/Makefile index d0c3cbf1020d5c292abdedf27627c6abe25e2293..5b3c56a7edd85d790019f01d9512b10c606ab9b6 100644 --- a/Makefile +++ b/Makefile @@ -3,18 +3,25 @@ # You can set these variables from the command line, and also # from the environment for the first two. +VIRTUAL_ENV ?= .venv SPHINXOPTS ?= -SPHINXBUILD ?= sphinx-build +SPHINXBUILD ?= $(VIRTUAL_ENV)/bin/sphinx-build SOURCEDIR = source BUILDDIR = build # Put it first so that "make" without argument is like "make help". -help: +help: venv @$(SPHINXBUILD) -M help "$(SOURCEDIR)" "$(BUILDDIR)" $(SPHINXOPTS) $(O) -.PHONY: help Makefile +.PHONY: help Makefile venv # Catch-all target: route all unknown targets to Sphinx using the new # "make mode" option. $(O) is meant as a shortcut for $(SPHINXOPTS). -%: Makefile +%: Makefile venv @$(SPHINXBUILD) -M $@ "$(SOURCEDIR)" "$(BUILDDIR)" $(SPHINXOPTS) $(O) + +venv: + @if [ ! -d "$(VIRTUAL_ENV)" ]; \ + then python3 -m venv "$(VIRTUAL_ENV)"; \ + $(VIRTUAL-ENV)/bin/pip3 install sphinx sphinx-rtd-theme; \ + fi diff --git a/make.bat b/make.bat deleted file mode 100644 index 6247f7e231716482115f34084ac61030743e0715..0000000000000000000000000000000000000000 --- a/make.bat +++ /dev/null @@ -1,35 +0,0 @@ -@ECHO OFF - -pushd %~dp0 - -REM Command file for Sphinx documentation - -if "%SPHINXBUILD%" == "" ( - set SPHINXBUILD=sphinx-build -) -set SOURCEDIR=source -set BUILDDIR=build - -if "%1" == "" goto help - -%SPHINXBUILD% >NUL 2>NUL -if errorlevel 9009 ( - echo. - echo.The 'sphinx-build' command was not found. Make sure you have Sphinx - echo.installed, then set the SPHINXBUILD environment variable to point - echo.to the full path of the 'sphinx-build' executable. Alternatively you - echo.may add the Sphinx directory to PATH. - echo. - echo.If you don't have Sphinx installed, grab it from - echo.http://sphinx-doc.org/ - exit /b 1 -) - -%SPHINXBUILD% -M %1 %SOURCEDIR% %BUILDDIR% %SPHINXOPTS% %O% -goto end - -:help -%SPHINXBUILD% -M help %SOURCEDIR% %BUILDDIR% %SPHINXOPTS% %O% - -:end -popd diff --git a/source/conf.py b/source/conf.py index ec706223b69f2f23e612b24ff6f9639f7c76c21f..a5b4bc012fc72ee6b363950cf6af4a18a86cce35 100644 --- a/source/conf.py +++ b/source/conf.py @@ -17,8 +17,8 @@ import sphinx_rtd_theme # -- Project information ----------------------------------------------------- -project = 'castellum-docs' -copyright = '2019, Goettel et al.' +project = 'Castellum' +copyright = '2018-2021, Goettel et al.' author = 'Goettel et al.' # The full version, including alpha/beta/rc tags diff --git a/source/workflows/consent-management.rst b/source/workflows/consent-management.rst index f1a90a943d0a720bf81479fb9a63857e915211fe..4454a84bf963b690d4fc88c45b8fa92417fed0c5 100644 --- a/source/workflows/consent-management.rst +++ b/source/workflows/consent-management.rst @@ -1,27 +1,29 @@ 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** diff --git a/source/workflows/deleting.rst b/source/workflows/deleting.rst index d61f471d6fabd6dc1a057b3801c08db15b04515a..66b5d4edc7ab9f6fcc435a7d9144bd2e1a944c50 100644 --- a/source/workflows/deleting.rst +++ b/source/workflows/deleting.rst @@ -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 diff --git a/source/workflows/study-creation.rst b/source/workflows/study-creation.rst index f3affa89bcf52f357211dbef65a25045c3ab5b5d..3235c1a1d3c5e88790ae62626ebca48157699905 100644 --- a/source/workflows/study-creation.rst +++ b/source/workflows/study-creation.rst @@ -1,42 +1,41 @@ 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**, diff --git a/source/workflows/study-recruitment.rst b/source/workflows/study-recruitment.rst index 32760a9dad26e428b56375eb90c0cc017955efc6..07efe517454a20a20a80fa2ad63764f512dcd4ad 100644 --- a/source/workflows/study-recruitment.rst +++ b/source/workflows/study-recruitment.rst @@ -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 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 diff --git a/source/workflows/subject-management.rst b/source/workflows/subject-management.rst index 07223d4efc1a8a05dc570b5fe6f3658c28a1443a..34ae0271a0fdbae6e0c5ed398f3248d319f3dc90 100644 --- a/source/workflows/subject-management.rst +++ b/source/workflows/subject-management.rst @@ -11,17 +11,17 @@ studies at the MPIB. The information you need to create the subject in the database should include at least the following: -- **First name** and **Last name**, -- **Gender**, -- **Date of birth** -- Information on whether the person is **Full of age** or **has legal guardian**, - If the subject has a legal guardian, you will need to **Add guardian** (see - instruction 8.b.) -- **E-mail** address and/or **Phone number** and/or full postal address and/or - contacting details of the legal guardian, -- **Handedness**, -- **Language** (Mother tongue) and -- **Highest degree** (in educational manner) +- **First name** and **Last name**, +- **Gender**, +- **Date of birth** +- Information on whether the person is **Full of age** or **has legal guardian**, + If the subject has a legal guardian, you will need to **Add guardian** (see + instruction 8.b.) +- **E-mail** address and/or **Phone number** and/or full postal address and/or + contacting details of the legal guardian, +- **Handedness**, +- **Language** (Mother tongue) and +- **Highest degree** (in educational manner) You can either ask for this information during a telephone call or you can transfer it from another source. @@ -38,86 +38,89 @@ In order to create a potential subject in Castellum, please proceed as follows: 3. Enter the first name and surname of the person - - The second first name can be specified, but does not have to be - - Keep the order as indicated - - First letters capitalized - - No comma needed + - The second first name can be specified, but does not have to be + - Keep the order as indicated + - First letters capitalized + - No comma needed 4. Click on **Submit** -4.1. If there is a **Match** found, the subject is already created in the database. - You may edit or add information by clicking on **Details** next to the subject + 1. If there is a **Match** found, the subject is already created in the database. + You may edit or add information by clicking on **Details** next to the subject -4.2. 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. 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 5. Define the **Privacy level** - - 0 (regular) describes an adult person without extraordinary features - - 1 (increased) indicates children or adults with a legal guardian - - 2 (high) presents a famous personality and/or their children + - 0 (regular) describes an adult person without extraordinary features + - 1 (increased) indicates children or adults with a legal guardian + - 2 (high) presents a famous personality and/or their children 6. Click on **Create new subject** In this tab, different legal basis for consent can be found 7. Add the consent that applies: - - **Recruitment consent**, - - **Study consent** and/or - - **Guardianship** + + - **Recruitment consent**, + - **Study consent** and/or + - **Guardianship** 8. Click on **Contact** - - Optionally you can enter the **Title** here - - You can edit the **First name** and **Last name** - - Define the **Gender** of the person - - Fill in the **Date of birth** + - Optionally you can enter the **Title** here + - You can edit the **First name** and **Last name** + - Define the **Gender** of the person + - Fill in the **Date of birth** + + 1. If the person is of an adult age, select **Full of age** and continue with + the following steps: -8.1. If the person is of an adult age, 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**, such as c/o details - - Specify the **Preferred contact method** + - Define at least one of the following contact details: **Email**, **Phone + number** and/or **Postal address** + - You may want to add **Additional information**, such as c/o details + - Specify the **Preferred contact method** -8.2. If the person is not of an adult age or has a guardian for example due to a - disability or illness, select **Has legal guardian** > **Add guardian** + 2. If the person is not of an adult age or has a guardian for example due to a + disability or illness, select **Has legal guardian** > **Add guardian** - - A new window will open - - Fill in the first and last name of the subject's legal guardian > **Submit** - - If a **Match** is found, select it - - If **No matches found** applies, click **Create** > Enter necessary information - in the fields provided > **Create new subject** + - A new window will open + - Fill in the first and last name of the subject's legal guardian > **Submit** + - 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 guardian is now added. You can also create several guardians. - By clicking on **Remove** next to the guardian's name, you can delete - them as the guardian of the subject + .. note:: + The legal guardian is now added. You can also create several guardians. + By clicking on **Remove** next to the guardian's name, you can delete + them as the guardian of the subject 9. Click on **Save** and then on **Attributes** - - Fill in the **First Language**, **Highest educational degree**, **Handedness**, - if the subject **Has hearing aid?**, **Date of birth** and **Sex** - - .. note:: - Although you already entered the **Date of birth** before, it must be - redefined again due to data protection reasons - - - If the person **Does not want to participate in the following study types**, - select one or more - - Click on **Save** + - Fill in the **First Language**, **Highest educational degree**, **Handedness**, + if the subject **Has hearing aid?**, **Date of birth** and **Sex** + + .. note:: + Although you already entered the **Date of birth** before, it must be + redefined again due to data protection reasons + + - If the person **Does not want to participate in the following study types**, + select one or more + - Click on **Save** 10. In **Data protection** you can: - - redefine the **Privacy level**, - - indicate whether the subject has consented to the recruitment, - - initiate an **Export request** and - - specify whether the subject is **To be deleted** -11. By clicking on **Additional Info**, you can define the **Availability** of - the subject + - redefine the **Privacy level**, + - indicate whether the subject has consented to the recruitment, + - initiate an **Export request** and + - specify whether the subject is **To be deleted** + +11. By clicking on **Additional Info**, you can define the **Availability** of + the subject - .. note:: + .. note:: Example: The person can be reached by phone between 9 and 11 a.m. on tuesdays. @@ -125,29 +128,29 @@ In order to create a potential subject in Castellum, please proceed as follows: - Hold the Shift-button and - Click on **11** under **Tuesday** -12. Below you can enter a point in time when a person is available again +12. Below you can enter a point in time when a person is available again - .. note:: + .. note:: Example: The person is abroad for 6 months. - Select **Not available until** today in 6 months -13. You may also want to select whether the subject is **Hard of hearing**, - **Difficult to understand** or uses **Abusive language** +13. You may also want to select whether the subject is **Hard of hearing**, + **Difficult to understand** or uses **Abusive language** - It is also possible to **Add a note** on your own. Important contact tracking - information that is visible to other recruiters can be noted here. - Please be aware that the use of note fields should be very sparing + It is also possible to **Add a note** on your own. Important contact tracking + information that is visible to other recruiters can be noted here. + Please be aware that the use of note fields should be very sparing 14. Define from which **Data source** the data comes from and click on **Save** 15. In **Study Participations** you can add any studies in which the subject has participated - - By clicking on **Add to study**, a list of current studies is displayed. - You can add the subject to one or more of these studies - - Click on **Add to finished study** - - Hold the **CTRL** key on your keyboard while pressing **F** to open the - search function of the browser - - When you found the study the subject participated in, click on **Add to study** \ No newline at end of file + - By clicking on **Add to study**, a list of current studies is displayed. + You can add the subject to one or more of these studies + - Click on **Add to finished study** + - Hold the **CTRL** key on your keyboard while pressing **F** to open the + search function of the browser + - When you found the study the subject participated in, click on **Add to study** \ No newline at end of file