diff --git a/source/workflows/consent management b/source/workflows/consent management new file mode 100644 index 0000000000000000000000000000000000000000..f1a90a943d0a720bf81479fb9a63857e915211fe --- /dev/null +++ b/source/workflows/consent management @@ -0,0 +1,116 @@ +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) + +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 + +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 +------------------------------- + +Consent documents are marked as invalid if a change in legislation occurs, substantial +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**Is valid** but leave the check in the box stating + **Is deprecated**, the consent document is generally marked as no longer valid + - If the invalidity of the consent is saved, there is no longer consent for + the recruitment of a subject in the database +This does not apply when the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 + + +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** + + +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 + +2. Go to **Maintenance** + +3. Click on the fourth tab **Consent** + + - You can see which **subjects have an outdated consent** in a list + +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 + +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 + +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 + + - 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** + +