Study

After this train, I will send you the training and your ID to connect.

Did you have already work on this environment ?

Ok I will show you the specificitys of this study.

We had already an interim analysis for this study and the committee advised to us to recruit only
moderate patients (with a clinical status of 4).

The study during 28 days.

We have one visit per day with a follow up for the 28 days after the discontinuation.

The primary endpoint of this study is a clinical status. It is a critical data for us according to the
protocol to make sure that the spo2 value and the 02 saturation is good compared to the clinical
status.

We have phone call pages and annex pages as study medication administration, concomitant
treatment. Adverse event.

In this study, we have two administration per day (one a morning and the evening). It is applicable
also for the isoquercetin.

Dynamism

A lot of dynamism has been built to facilitate the data entry and avoid any issues.

Dynamism on laboratory data are present:

– Initially, you can only visualize the results entered, then if you select “the number of
lab”, entire page will be displayed (ranges and units).

Source data validation (DSV status)

After have to verify if all data are correctly recorded in comparing with the source data, to SDV on
completed page tick on this icon

Choose the option

The status SDV is applicable only when the page is « Completed » without active query.

Please Note: When the data changed in one page, the status of the page will be back to
«Completed».
Queries

How create a QUERY?

• Go to the selected field
• Click on the botton
• Choose the option
• A new window will be opened then click on « New query ».

• Below window will pop-up :

• Choose the query type

• Write the query text in the comment box
• Then click « Accept » => The query will create.

• The active query will be hilighted by the following icon

To displaying the queries the eCRF :

• You go directly on the page

To displaying the queries from subjects tab :

• In the subject tab choose the section “Open queries Overview”

• Choose the site number or subject number

• Click on “Show”, the active queries listing will appear: