Quick Start user guide for EDC

Video:

Step 1: Applying study settings

A new study will be set up for you, but you can still change several options and standard features. Navigate towards management and click on ‘’General study information’’. Here you can fill in the information about the study: study number, study title, start date and end date, and a few options you can turn on or off for your study such as Patient Self Service or randomization.

Some options are only available when other options are turned on first. For example, randomization options that are only accessible when the option of using stratification or randomization in your study is ticked. If you want this, you can also fill in a few lines with general study information.

Click ‘’Save’’ in the bottom left corner of your screen, to save any changes made to your study settings. More information about the available features such as PSS and Randomization can be read on the support page.

Step 2: Building the CRF
Click  ‘Management’ on the main menu, and then under the sub-heading ‘template configuration’, click ‘study template’.

The screen you now see is divided in two; on the left you see the navigation overview, also known as the treeview, while on the right you will find the content of the headers you selected on the left.

The study template has different layers: chapters -> subchapters -> paragraphs -> components. If you select a chapter on the left, you will see the subchapters that are a part of the chapter, on the right.

If you select a subchapter on the left, you will see the paragraphs that are a part of the subchapter, on the right. If you select a paragraph on the left, you will see the components within that paragraph on the right. It is not possible to skip a level when building a study: For example, components can only be placed in paragraphs and not directly in subchapters or chapters.

Click ‘’add chapter’’. In the pop-up that appears you need to fill in a title, a description (not required) and an export tag. Then click  ‘’save and close’’. You now see the navigation overview in the chapter.

When you click on the chapter and nothing appears, it is because you haven’t added any subchapters to the chapter yet. You need need to click the plus icon left of the chapter title. This way you unfold the chapter. Next, click  ‘’add subchapter’’. Fill in a title, a description (not required) and an export tag. Then click  ‘’save and close’’.

Finally you should add a paragraph under the subchapter in the same way.
You will see that the paragraph in the navigation overview cannot be unfolded. But if you click on it, the components of the paragraph will appear in the main screen. You add this by clicking on ‘’add component’’ in the right corner. In the pop-up that appears you can fill in the title and you choose the type of component. Click Save & Close.

You can edit and further specify the component by clicking on the pencil icon below ‘’edit’’. This opens a pop-up with multiple tabs.

1. Base properties: No matter the type of component there are a few base properties that are always available. You can read more information about the base properties of a component on the support page.
2. Specific properties: Components have specific properties next to the base properties, the settings on this tab are dependent on the type of component and so they differ for all different types of components. You can read more information about the specific properties of a component on the support page.
3. Conditions and dependencies: Lastly, we show tabs to install conditions, and to show all the dependencies of a component. You can read more information about conditions and dependencies on the support page.
   
   

Step 3: Adding patiënts

1. Navigate through the main menu -> CRF -> CRF data;
2. Unfold a site by clicking on the plus icon;
3. Click ‘’add patient’’;
4. If applicable fill in patient details;
5. Click ‘’save and new’’ or ‘’save and open’’.

If you have added a new study and ceated a template exactly how you wanted it Now you can start adding patients, so you can start collecting data. In ResearchManager this happens in the CRF: the Clinical Research Form. Here you can add new patients and fill in all the relevant information. Then you can start inserting data immediately. You can find more information on creating or managing patients on the support page.

Step 4: Inserting Data

Steps

On the top of every questionnaire there is a menu called "actions", here you can change the status of the questionnaire:

• Empty everything: Empty all the questions of the concerning subchapter. The subchapter regains the status ‘’empty’’. For all the questions there is an audit trail being kept.
• Save as missing: You can save the subchapter as missing. By giving the questionnaire this status, you save the data you have worked with up until that point, but point out that there is still information missing. There will not be any supervision on the mandatory fields when you choose this status.
• Save as incomplete: By saving your subchapter as incomplete, you show that there is still information to be filled in. When a patient does not completely finish the subchapter through PSS this status is given.
• Save as complete: When you have answered all the question, you can save the subchapter as complete. When a subchapter has reached this status, the specialist can sign it. So be cautious that you do not give this status to the subchapter when you know there is still data to be filled in.
• Sign: When a subchapter is finished a research specialist or data manager can sign it. After this there can no longer be made any changes to the subchapter.
• Monitor: This status can be given to a subchapter by a monitor to signal that he has seen and evaluated the subchapter.
• Block: A subchapter can be blocked, which means you can no longer insert data. This is convenient for when a patient does not meet the inclusion requirements and any further data will not be useful.
• Unblock: When you have blocked a subchapter, but decided at a later moment that you still want to edit data, you can unblock it again. This makes inserting data possible again.
• Log in as a patient: By clicking this button, you will be logged out of ResearchManager and logged in on Patient Self Service for the concerning patient. This is especially convenient when a patient cannot the PSS module at home. He can fill in his data on your computer without getting access to for example the data of other patients.

When you have incorporated a recurring subchapter in your template, you can add the recurring questionnaire by clicking “Add [Name recurring chapter]’’ and fill in a reference. When you click on ‘’save’’, the questionnaire opens.

You can read more information on filling in Data or other possibilities under the menu CRF on the support page.