How can I set up a study? (Step 1)

Modified on Fri, 25 Apr at 1:24 PM

Learn how to fill in all the fields in the first step of the study module correctly.

After you have clicked on the button "Create new study", a new window opens. In the first step (1. General) you will be asked to provide general information about your study.

There are three fields in this step that are required in any case.

	Firstly, you must give your study a name. Please make sure not to use the following special characters in your study name: *" . $ ? & [ ] ™️ / \ -**
	Next, you must specify a study coordinator. By default, you will be entered by the system. In principle, a study coordinator has no special rights. However, his/her rights can individually be adjusted in this step. You can find more information on this in the following article: How can I set collaborators and edit their rights?
	Finally, you must define the name of the individual subject ID. By default, the so-called SIC (Subject Identification Code) is already entered here. Here you have the option of deciding between two logics. Increment: This is the automatic incrementing of the SICs based on the site ID and 4 digit counter of subject at the site. Random: The system randomly assigns the respondent SICs consisting of letters and numbers. Here you can further specify whether only upper or lower case letters or even both should be used. Numbers are always included in this case

	You will see the SIC mainly in the general study overview and the entry interface of the respective subject. You can find more information on this in the following article: Subject overview in a study

All other fields can, but do not necessarily have to be, filled in. However, some of these fields can offer you a few advantages.

	Here, the status of the study can be set. While you are still in the initial setup phase, it should be set to "In Preparation". During the User Acceptance Test, you can set the status to "Testing". This has no impact on the settings of the study, but will serve you as an overview of the setup status. Once the study is activated, you cannot revert its status to "In Preparation" or "Testing." However, if you need to make updates while the study is active, you can create a sandbox environment to implement and test your changes before publishing them to the active study (find detaills here). There are two ways to activate the study. To find out more, please click here. Finally, the study ends with the status "Completed". Read the following article for more information: End of Study
	A description might make sense especially if you will manage several projects on your instance. The description appears in the general study overview below the study name.
	You can choose between the two study types "Medical study" and "Product study". Selecting "Product study" only makes sense if you also use our product module. If this is not the case and you are still conducting a study on a product, you should still select "Medical study" here. This distinction has no further implications.
	At this point you can select whether your study is a monocentric or multicentric study. If you have a multicentric study, you can make the access to the individual centres granular. Read the following article: How to set up collaborators and edit their rights?
	Primary Language: The primary language should align with the language of the study setting. This selection influences the language displayed to the patient in the system, such as "save" versus "speichern." All customizable texts (e.g., validations, ePRO invitations, self-registration emails) will automatically appear in the primary language you choose. You can, of course, adjust or modify these texts as needed to better suit your study requirements. Available patient facing system languages: Currently, German, English, and Spanish are supported. International studies: For international studies, the study is still set up in a single primary language (e.g., English). Additional languages (or secondary languages) can be configured in Step 6 of the setup process. Please note that, as mentioned above, only English, German and Spanish patient facing system languages are available. If you would like to find out more about the customisable email notifications to test subjects, read the following article: How can I edit ePRO settings? If you would like to learn more about how to change the system language for end users (such as doctors, study nurses, etc.), please read the following article: How do I switch languages in Climedo?
	In these two fields you can indicate when the study should start and end, respectively. However, this has no impact on other settings in the study. The start and end dates are only displayed in the small information bar in the study overview.
	In this field you can enter the predefined minimum number of subjects. When you do this, a scale appears on the general study overview, on which you can follow how many entries have already been entered into the system. This function has no effect on other properties of the study. You can end the study even if you have not reached the number of subjects you initially defined and also add more subjects than the number indicated.

	Enabling this allows collaborators to provide and edit a manual Subject ID, which overwrites the system-generated format in the form of [Site ID] [4 digit counter of subject at the site]. If no input is provided on enrolment, the system-generated format will be created. Read the following article for more information about the subject enrollment.
	At this point you can determine which personal data should be queried and stored in the system when a subject is enrolled. If you use ePRO(s) (specified in the workflow), the email address and/or phone number is automatically toggled on. The patient ID is an additional ID to the subject ID (often referred to as SIC), but is totally optional. This function is often used when a subject is taking part in several studies at the same time. Using the PID, a unique code can be assigned to the patient that is the same in all studies, although the SIC may change. If you click on "Advanced subject information", additional data points such as name, date of birth, gender can optionally be filled out for a subject as well. Please note, that information such as the e-mail address or mobile phone number are not included! If you want to include them as well please make sure to check the respective boxes.
	If you activate this option, you will be explicitly asked for the reason for each change made after a data save. For GCP compliant studies this should be enabled.

✉️ Still have questions? Feel free to contact your Customer Success Manager or email us at support@climedo.de.