Subject overview in a study

Find out here what information you can obtain directly from the subject overview.

How to get there?

To access the subject overview, please go to the study module and choose the desired study in the general study overview. Now you can simply click on open subject overview.

Then you will be forwarded to the subject overview:

Further explanations of the columns:

SIC	In the first column you will find the individual subject number (in this case called SIC). Next to the SIC you will find two blue icons. If you click on the  form icon ("Open input form"), the input form(s) for the respective patient will open. If you click on the person symbol ("Open subject profile"), the subject profile of this patient will open. In this profile you will find all information regarding the subject, if these will be collected (examples: email address, telephone number, personal data). It is dependent on your study settings and can be customized.
Site	In this column you can see at first glance to which site the subject is assigned. If you are conducting a mono-centre study, only the name of this one site is displayed here. Important: If you are conducting a multi-centre study, the respective persons (e.g. investigator or study nurse) will only see the patients who are assigned to their own sites.
Consent	There are 5 (e)consent related columns. "Consent type" indicates whether the subject has / will sign an e- or paper consent. "Consent status" indicates the status of the consent, meaning whether is has been sent / handed out the the patient, whether signing is in progress, has been cancelled or has successfully been signed. The consent signee column shows the investigator that has been assigned to sign the consent, whereas the "Signature request updated" column shows the time stamp when the consent status has been last updated. Lastly the "Signature request sent" column shows the timestamp when an eConsent signature request has been triggered. Please read the following article to learn more about our eConsent: How to use the eConsent feature in Climedo
Status	In this overview you have the possibility to adjust the status of the subject. To do this, click on the "Active" button for the respective patient. Now you can choose between three different statuses: "completed", "ineligible" and "dropped". The status "completed" means that no further data can be entered for the subject. However, input forms can still be locked and/or signed. Read more about this here: How do I lock/unlock an input form?  How do I sign/unsign an input form?
	In addition, queries can still be set. Read more about the queries here: How do I manually create/close queries?  The three statuses "completed", "ineligible" and "dropped" mean that (if applicable) no more ePROs will be sent from that point on. Please be aware that the statuses in the ePRO overview do not change until the time of sending. It still says that ePROs are or were scheduled for the scheduled days (including past days). After all, no mails are sent and no changes can be made in the already completed ePRO. Only in the details does it become apparent that this ePRO was not sent (including the reason). Furthermore, you can also change the status of the subject via the actions. To do this, select the subject on the far left of the table, click on "Actions" and select "Update subject status" (compare further below).
	Furthermore, you can mark the subject as "Done for today" via "Update subject status". If you click on this function, a blue calendar symbol appears next to the status in the subject overview. This is reset every day at midnight. This marking has no effect on other functions. It only serves to facilitate your daily work.
Randomization	There are three randomization related columns that can be displayed. "Randomization" indicates whether a subject has been randomized yet or not, and if yes to which group the subject was allocated to. "Randomized by" shows the collaborator who performed the randomization action for this subject. "Randomized at" gives information on the timestamp of when the randomization was done. ⭐ Good to know: If you only see a tick in the Subject Overview, but not the group assignment, this means that you have been blinded for this study. Randomisation reading rights are defined in the Access Management of the study. If you think you need to see the randomisation group, please contact your study coordinator.
Data collection	Under data collection you can directly display (if applicable) which type of data entry it is (ePRO or non-ePRO). If you change a patient to "non-ePRO", no ePROs will be sent. The entry in the respective forms is then made via the roles that have the authorisation to enter data (e.g. investigator, study nurse). Refer to the chapter "Customized views" in this article to learn how to show this column in the subject overview. In principle, the data collection method is determined when the subject is enrolled. Read the following article for more information.
Assignee(s)	The assignee of the subject is shown in this column. This is selected when the subject is enrolled.
(S)AE / AE	The system enters a marker in these two columns as soon as an SAE or AE has been created for the respective subject. The number inside the circle indicates how many (S)AEs have been created for the patient. As soon as an (S)AE has been signed, the colour changes to green. Thus, this event is considered "resolved". Learn here how to create an (S)AE for a subject. If more than one (S)AE is recorded here, the lowest status of all (S)AEs for the subject is shown here in the overview.
Queries	The system also enters a mark in this column as soon as a query has been created. Similar to the (S)AEs, the respective number per subject and the status is also displayed here by means of  the colour. If more than one query is created here, the system will orient itself to the lowest status of the respective queries of a subject. For example, if you have two queries, one of which is closed and one of which is in progress, the colour yellow is displayed here. The following articles may be of interest to you: How can I edit queries?; How do I manually create/close queries?
Progress	This display shows you what percentage of the questions have already been answered (whether in the eCRF(s) or in the ePRO(s)). It is important to know that the progress is composed of the input fields that have been marked as required. If there is only one field marked as required, the system will register the questionnaire as 100% completed as soon as this field is filled. If there is not any field marked as required, the system will consider all open questions. If there are both required and non-required marked fields, only the fields marked as required will still be considered for the progress. Required fields hidden by a dependency are not considered missing and are not calculated in the progress.
Locking	This column shows you the current status of the lockings of the input forms. The lock is red if no required input form have been locked yet. Yellow if at least one required form has been locked and green if all required forms have been locked. Whether a form must be locked or not is determined when the input forms are created.
Signatures	This is similary the case in the locking column.
ePRO	The ePRO overview will be discussed in more detail in the following article: ePRO overview in a study.
Updated	As the name suggests, this column shows the date and time stamp when the respective subject was updated within an input form. If you hover over the respective timestamps, you can see at a glance in which step, which form an input field was updated with which value.
Created	In this column you can find out on which day and at which time a subject was entered into the system.

Subject Overview Shortcut

No matter where you are within your study (in this case, in the entry interface for a subject), you will find the direct link to the subject overview in the sidebar. Click here to get to the view.

Search bar and actions

Our search bar is currently under construction. However, we generally recommend that you work with the smart filters. If you would like to know more about the smart filters, read the following article.

Furthermore, you can select (several) subjects on the far left of the table and carry out various actions. These actions adapt to you individual rights and also on the respective number of chosen subjects. The individual actions are described in more detail in the respective knowledgebase articles: What "Actions" can I perform in my subject overview?

⭐ NEW: 

Predefined / Customised views

Depending on which modules are activated in your study, predefined views appear in the subject overview, which of course can be customised. 

To do this, go to the tab that you would like to customise. Now click on the wheel next to the tab name. A small pop-up window opens. Now you can select which information you would like to have displayed in the subject overview. Then click whether on "Update and save current view" or "Create new view". You can now either customise the existing view name or assign a name to a new view.  Under visibilty, you determine whether this view should be visible to everyone (public) or only to you. The "public default" setting marks this view with a star and places it in first position.  Depending on the view selected, the columns are pre-filtered accordingly in the subject overview. Of course, you can also delete the predefined views. Please note that only the "All Data" view cannot be deleted. You can use the plus sign next to the predefined views to create and save a customised view.

If the colorblind mode is enabled, locking and signature status is shown with numbers instead of colored icons, e.g. 1/3 signatures

Study step view

Finally, you can even display the individual study steps and corresponding input forms or fields. If you click on "All steps" above the table, a drop-down list opens in which you will find all study steps. If you now click on a step, you can select the respective form in the new drop-down list to the right of it.
If you now click on the plus sign next to the input form name, all input fields created in this form appear together with the entered answers.
If you have a step with several input forms, you can even use this view to see directly how far along the completion status is for the individual subjects in the respective forms.
⭐ If you click on the paper symbol directly next to the SIC after selecting the step and the input form, you will be taken directly to the input interface for exactly this step and this input form.

Videos

How to switch ePRO to non-ePRO and back

Imagine the following situation: Your subject was unable to open the ePRO in our system due to internet issues, and therefore could not fill out the questionnaire online. However, the subject has completed the questionnaire on paper and now you want to transfer this data to the Climedo system. Normally, data in an input form marked as ePRO cannot be edited by other parties (for example by an investigator or a study nurse) other than the subject. For situations like this, Climedo has a solution: changing the data collection method from ePRO to non-ePRO. In this video, you will learn how to do this.

How to "mark as done for today"

When dealing with a large number of subjects in Climedo, it is useful to mark individual subjects as "Done for today". This function can be used for various purposes, but is mainly utilized by monitors to keep track of whether they have monitored a subject for the day or by study coordinators to mark todays data entry for a specific subject as done before moving on to the next subject. Note that this marking is not linked to any other function in the system and is automatically removed every day at midnight. This function requires a role permission to be enabled. 

How to set up and update views in the subject overview

In the subject overview, you will always see several default columns to structure the study data in a so-called “System default view”. However, you might want to add more information (in the form of columns) to your view if those functions have been made available for use in your study.

For example - the SDV feature is enabled and you want to include the “SDV process” column in your view or create a specific “SDV only” view so you can easily track the SDV status of your subjects.

This video will show you how to create and update your own additional views or create views to share with all users.

How to view actual data in subject overview

Imagine you are conducting a study and need to quickly access the system to view the actual answers given to specific questions, for example by a subject completing an ePRO on site where the answer to a specific question defines the next steps. In this video, we will demonstrate how you can easily view and compare data points in the subject overview with just a few clicks.