How do I create and edit a study workflow (Step 4)

Learn here how you can configure your study steps.

Step 1:

1. After logging into the system, click on the "Studies" module.
2. Choose the study you would like to edit and click on the "..." button in the lower right corner next to the "Open" button.
3. A small pop-up window opens - select the option "Edit".

Step 2:

1. Now you will see the configuration mode of your study. Select Step 4 "Workflows" to start editing the workflow or to view the already created workflow.
2. To create your workflow, click on the "Scheduled Events" tab and select "Add a new study step".
3. A new pop-up window opens.

Step 3: 

We distinguish between three different step types: "Visit event", "Subject event (ePRO)" and "Information event". There is no difference between a "Visit event" and an "Information event" in terms of features or functionality; the only distinction lies in minor layout design variations.

	If you want to insert a study step as a CRF into the workflow, select "Visit event" here. You can read more about the creation of an ePRO step here. The following information refer to "Visit or Information events" only.
	A study step always requires a name. This name will be displayed in the eCRF as the naming of the visit to the sites/investigators etc.
	To add an input form to your study step, click on "Add new form". A list of the input forms, which were created so far, will appear. Click on the input forms you want to assign to this study step. If you still need to create the form you want to use here, you can click on "Create new form". Read here what you need to consider when creating an input form and how to fill the form with content.
	As soon as you have selected the respective input form, it appears in the list above.
	When clicking the burger icon, you have the possibility to adjust the order of the input forms via drag and drop.
	You can always change the display name of the respective forms by clicking on the pencil icon. These names will be displayed to the sites/investigators as described above. It won't change the name of the input form itself.
	You also have the option to use the "x"-icon to remove an input form from a step.
	Last but not least: Don't forget to save your changes. Note: Before you can add form dependencies to your workflow it needs to be saved at least once before.

For all further steps repeat the above steps. 

If you have several steps and want to change the order of the steps, drag the step to the position by clicking the burger-icon and holding down the mouse button.

To the right, you will notice two essential functions within the workflow: "Bulk locking" and "Bulk signature". These functions serve the purpose of facilitating the locking and/or signing process for multiple input forms, accommodating a total of up to five subjects.

Read more about this in the following articles:

• How do I sign/unsign an input form?
• How do I lock/unlock an input form?

Step 4:

Configuration of the Participant Consent

First you can request the subject's consent for collecting data in the case of an ePRO sending. Please note, this consent should not be mixed up with the basic (regulatory) declaration of the informed consent for the study participation. When activating the participant consent feature, it will be sent with the first ePRO. Be aware that the subject has to check the box to be redirected to the ePROs automatically afterwards. In Climedo we also offer eConsent. Read more about this in the following article: How do I set up and use eConsent in Climedo?

Step 5: 

Configuration of the reply-to e-mail

Furthermore you can specify a reply-to email for ePRO usage. The email for the ePRO send out will still be no-reply@climedo.de. But if the recipient/patient answers this email anyways, his/her response will be forwarded to this message reply-to-address.