How do I enter data into Climedo?

Learn more about our user interface and how data entries work.

Data entry

After a subject has been enrolled into the system, the data entry screen for this patient opens automatically. If you want to enter data for the respective subject again, click on the sheet icon ("open scheduled events") next to the SIC.

If you like to enter or update data in a specific study step and input form, you can change your view via the "step and form" dropdown (in the screenshot called "All steps"). After jumping into the step or even form you want to update, click on the sheet symbol and you will be forwarded directly to the desired input form. See also the following article (last paragraph): Subject overview in a study

Once you are in the subject's input form, you will see the top view.

	In the first row you can see all study steps. You can click on the respective steps to switch into them.
	Sometimes (it depends on the total amount of study steps accessible), the study steps appear as a drop-down list. This is done automatically by the system for better overview. However, the functionality remains the same. You can still select the individual study steps.
	Below, you will find the input forms that belong to the study step. Here, you can also switch between the respective input forms by clicking on each form name. Scroll down within the form to get to the input field(s) you wish to update.
	Alternatively, you can search for specific input fields in the search bar.

Navigation in the input screen

When clicking on the sheet icon () next to the SIC in the subject overview you are taken to the steps and forms of the "Scheduled Events", which are the forms of your study (including ePRO steps if implemented).

Here you also have the option (if applicable for your study) to switch between the different areas: Unscheduled Events, (S)AE Forms, Samples, Subject Profile and Wearables (depending on the activated modules for your study). To switch to another area, click on the arrow next "Scheduled Events" in the top bar. A drop-down list opens. Here you can select the different areas, like the subject profile. Read the following articles for more information regarding the subject profile and the (S)AE module: 

How do I report an unscheduled event?

How and when do I use the Subject Profile

How do I create a Sample for a subject (in progress)

How do I report an (S)AE?

Actual data entry

Fill the input fields with new or updated data as applicable. Validations and/or dependencies will guide you. Some fields might only be visible and available for entry if a specific answer has been given previously.

Upon updating all input fields as applicable scroll to the bottom of the page and save all entries by clicking "Save changes" (green button).

If you cannot answer a field that has been marked as required for various reasons, you can use the "..."-button next to the question to mark the field as unavailable. When you do this, the input field of the question disapperas and the following text appears: "Field marked as unavailable ...". You can always reverse this action. 

⭐ Good to know: If just created screenshots are to be uploaded into the file upload field, there are differences between the two operating systems Windows and IOS:

• IOS: Here you can simply drag and drop the screenshot into the upload field. The image is uploaded without intermediate storage.
• Windows: Here you have to save the image briefly on your device in order to upload it either by drag and drop or by the classic selection from the Explorer (computer drive)

⭐ Good to know

If your completed fields are dependent on another field which you update again, you might hide the completed fields (again) in the process (based on the type of dependency). This means that data entered to this field will be deleted and no be present in the data exports. If you reverse your dependency field to the original reply, thus making the dependent fields visible again, the previously entered data will have to be re-entered as hiding the input field automatically deletes the entered value. 

⭐ Good to know

If you leave the form without saving your changes a pop up window will appear prompting you to continue the data entry or discard the changes. You can also choose to discard them directly by clicking on the orange "dismiss changes" button next to "save".

⭐ Good to know

If a form is locked (green lock symbol ), you will not be able to make any data entries. If a form is signed (green pencil symbol ), you will be prompted to confirm you are aware that the signature will be removed if you save your updates.

Refer to the applicable articles on signatures and locking for details.

⭐ Good to know

You might be asked to give the reason for your data changes to fields with previously saved entries (Require reason for change (GCP)). When updating more than one input field with already saved changes, you can give a reason for each field or one reason for all fields and changes.

⭐ Good to know

The set up "Only save when all required fields are filled to 100%" might apply for specific forms. In this case you will only be able to save entries in the form if this condition is fulfilled.

⭐ Reminder: 

You cannot make data entries within ePRO steps, unless your study allows to change the data collection method to non ePRO. For details see the following article: Subject overview in a study

Refer to the following article on queries and data changes and on the display of the completion status based on data entry (Subject overview in a study)

Validations

Under certain circumstances, a (green, orange or red) text may appear directly below a question before or after data entry. These texts are called validations. They could be, for example, preset limit values or instructions.

Dependencies

Under certain circumstances, questions that were not visible before may appear if you answer previous questions in a certain way. There is nothing more to note here. Please also answer the newly added questions in the usual way.

⭐Fun Fact

Videos

How can documents be uploaded, used and downloaded within the upload field

There are several locations in our system where you can upload files for a subject or an entire study. In this video, we will focus on the file upload field. Please note that only certain file types can be uploaded. For more information refer to our Knowledge Base article "Permitted data types for file upload." Please note that you need update rights for Scheduled Events for this action. If you are unable to upload documents, contact your monitor or project manager. 

How to mark/unmark as unavailable

To imply the actual unavailability of data in the eCRF and to distinguish it from data currently missing to be entered at a later time, the data point can be appropriately marked as “not available”.

For example you might have the information that a medication has been stopped, but you know already you will never receive the actual stop date. You mark it as not available to confirm it is not missing or pending, but cannot be provided.