How to configure and use the Self-Registration feature in Climedo

Learn how to set up Climedo to enable subjects to self-register to a study.

With self-registration, subjects can quickly and easily sign up for a clinical trial via QR codes or (shortened) links without having to rely on clinical trial personnel to assist them. 

This feature reduces the workload for clinical trial personnel and makes it easier for subjects to access the trial remotely. 

Please note that Self-Registration is a premium feature and needs to first be enabled for your study by our Customer Success Team.

The below steps describe the self-set-up and usage guidelines of this feature within Climedo: 

Configuration

	To start the feature configuration, navigate to study set-up step 4 (Workflows).
	Here you can see that the "Self-Registration" step has automatically been added as the first step of your workflow. The step can be edited by clicking on the "edit" icon on the workflow step as usual. Please note that if the Self-Registration feature is enabled for your study, this step is mandatory and therefore cannot be moved or removed from your workflow.

	After opening the configuration of the Self-Registration workflow step, navigate to Step 2 (Contact information form) to configure the contact information form with which you collect the required information of the subjects in order to register for your study.
	On the left you see all available input fields that can be added to the contact information form via drag and drop.
	Define which fields are required for the subjects to fill out during the registration. As the e-mail field is always required for this feature in order to enable the double-opt in functionality, this input field is by default added to the form and marked as required plus it can not be removed. Moreover, the contact language input field will by default be added, if the translations module is enabled, in order for the subject to select the ePRO form and email communication language of choice. However, the position in the form can be changed.

	For the configuration of the double-opt in email as well as the success screen, you can navigate to Step 3 (Double opt-in). Background: When self-registering, subjects will receive a double-opt in email to confirm the correctness of their email address.
	To view an example of what the self-registration flow including the contact information form, the double-opt in email as well as the success screen, click on "Example flow".
	To configure the email text that the subject shall receive to confirm its email address you need to: 1. Define the email subject 2. Optionally provide a reply-to address 3. Add the text that shall be shown on the conformation button (confirmation button text) 4. And lastly add the message body
	As a last configuration step inside the Self-Registration workflow, you need to define what the success screen shall look like after the subject has successfully confirmed its email address and has been registered for the study. This configuration setting provides you all options of a rich text field, which means you can define the heading, the body, the font type and size and also, e.g., upload a picture. Inside the example flow you can see an exemplary success screen.

Access Rights Configuration 

Currently, there is one access right connected to Self-Registration called "Generate QR Code", which enables the holders of this right to generate registration QR codes and links for subjects to scan with or type into their phones (or other mobile devices) in order to start the registration process.

	To assign the required Self-Registration "Generate QR Code" access right to your roles, you have to navigate to study setup step 2 (Access, Roles).
	The right can be found below subject rights.

Self-Registration QR Code Generation

Please note that as a prerequisite to be able to generate the QR codes / registration links you need to hold the respective "QR Code Generation" right as described in steps 10 and 11. 

	To generate the QR codes or links that subjects can use to register for your study, click on the QR code icon next to the "Actions" button in the subject overview. Alternatively, you can also navigate to the study overview click the QR code button on the study card of your respective study.
	You can choose from two QR code/link options: 1) Generic QR codes and links: Each generated code is associated with a specific site. When scanning, the subject will be assigned to the respective site. This type of code is covering most use cases as it is useful when making the same QR code available to multiple potential study participants by e.g. printing it on flyers, newsletters or distributing it via social networks. 2) Unique QR codes and links: Each generated code is associated with a specific subject and therefore the SIC (study entry ID). In this case, one QR code should be generated per subject. This type of code may be useful if patients and SICs are known before and specific subjects should be assigned to these pre-existing IDs (e.g. for data matching between different systems).
	For both types, and if your study has multiple study sites, select the site(s) that you want to generate the QR code(s) for.
	For the unique QR codes choose how many codes you would like to generate. Please note that the maximum amount of unique QR codes that can be generated at once is 50.
	After clicking the button "Send codes to my email", the following will be sent to your email:  a zip file including the Self-Registration codes in png format a csv file including the registration link(s) as well as the associated site IDs (for generic links) and subject IDs (for unique links)

Self-Registration Flow – Patient View

Below you can see an exemplary patient-facing self-registration flow and how to trace whether a subject has self-registered or was enrolled by the study personnel. 

	First the subject will have to fill in the contact information form.
	Once all required fields have been filled in the contact information form, the subject will receive a double-opt in email to confirm its email address. In addition the subject will be asked to check its email for the confirmation email and in case the email was not received, the subject can re-trigger the double-opt in email up to 10 times within 24 hours from the success screen.
	Exemplary view of what a customisable double opt-in email can look like.
	Exemplary view of what a customisable double opt-in success screen can look like.
	To trace whether a subject has self-registered to a study or was enrolled by the study personnel, a new column called "Enrollment type" has been added to the subject overview. The following enrollment types are available: By subject (used when a subject has self-registered) By site (used when the subject was enrolled by the study personnel)