Booklet overview on the study start page

When you select the study icon on the landing page, the study start page loads. The booklet overview page is displayed by default.

1. Booklet overview icon
2. Icons giving access to other Viedoc functionality, these are described in Study start page. Note that these icons are displayed based on your rights and permissions, so you might not see all of these, or you might even see other icons.
a. Study status
b. Messages
c. Data export
d. Metrics
e. Roles
f. Medical coding
3. Launch button to enter the study
4. eLearning/Documentation & Training
5. Filter the displayed booklet information for country, or select All sites to display booklet information regarding all sites in the study.
6. Receive button. Select to receive all booklets that were submitted since the last time a receive action was performed.
7. Total number of received booklets. Select to enter the Selection page displaying all received booklets. See Booklet overview on the Selection page below.
8. The date of latest import and the number of booklets imported. Select to enter the Selection page displaying only the booklets received during the last import. See Booklet overview on the Selection page below.
9. Latest import tab, displays booklet information (see 11-14) of all booklets imported during the latest import.
10. All booklets tab, displays booklet information (see 11-14) of all booklets in the study.
11-14 display booklet information of booklets among the latest import or among the total number of received booklets, depending on the tab that has been selected (see 9 and 10). These links also serve as shortcuts to enter the Selection page displaying the respective booklets:
11. Number and percentage of booklets to review. Select to enter the Selection page displaying the booklets that contain data to be reviewed.
12. Number of booklets that contain unreported Adverse Events (AE). Select to enter the Selection page displaying the booklets with unreported AEs.
13. Number of booklets that contain issues. Select to enter the Selection page displaying the booklets that contain issues.
14. Number of booklets that are returned. Select to enter the Selection page displaying the booklets that are returned from the sponsor side to the clinic side.
15. Number and percentage of booklets that are completed (frozen). Select to enter the Selection page displaying the booklets that have the status frozen.

Booklet overview on the Selection page

On the booklet overview of the Selection page, booklets are displayed in a table. The main purpose of this table is to give the sponsor side user a quick overview of the booklets that require action: AE reports and booklets containing AEs and issues are therefore listed first. Each row in the table represents one booklet, the columns provide the following information:

1. Avatar representing a subject and displaying the subject's sex
2. Subject ID
3. Name of the booklet
4. State of the booklet (Not submitted, Received, Returned, Frozen)
5. Latest activity: describing the latest action performed with the booklet (Received, Partly received, Returned, Partly returned, Frozen)
6. Latest date: date of latest activity
7. Latest user: name of the user that executed the latest activity
8. The symbols in the last column indicate if there are actions to be taken. They summarize the status of the booklet (Submitted, Returned, Frozen), or indicate if the booklet contains any issues or AEs. See below for more information.

On the selection page, you can perform or view the following:

1. Search through subjects and booklets by entering any string in the search field
2. Switch to the card view (see below)
3. Switch to the issue list (see below)
4. Switch to the booklet overview (if you are on the card view or issue list)
5. Filter the displayed booklets for booklet name by selecting All booklets or the booklet name from the drop-down list
6. Filter the displayed booklets for booklet status by selecting one of the following options from the drop-down list:

• All statuses
• Has AE
• Has issues
• Not reviewed
• Returned
• Frozen

7. Switch to the previous or next page of the booklet overview.
8. Select how many booklets should be displayed per page.
9. The color band displayed in front of the subject avatar means the following:

• orange: booklet has been received and is under review by a sponsor side user
• blue: booklet is frozen
• red: booklet contains issues that need to be solved
• grey: booklet has been returned to the clinic side and is no longer under control of the sponsor side

From the Selection page, you can also enter the card view and issue view by selecting the Cards and Issues tabs as follows:

The icons in the last column of the Selection page have the following meaning:

Symbol	Definition
	Received - the complete booklet has been signed and submitted by the clinic, and received on the sponsor side.
	Issue - at least one open query and/or missing data
	Frozen - the booklet has been frozen on the sponsor side, and is locked for data edit
	Returned - the booklet has been returned from the sponsor side to the clinic side
	Adverse Event - this form contains an adverse event
	Adverse Event reported - the adverse event in this form has been reported to the authorities

By default, booklets are sorted in the following order:

• First sorted by state:

  1. Booklets that are not reviewed and contain AEs or issues.

  2. Booklets that are not reviewed and do not contain AEs or issues.

  3. Booklets that are reviewed booklets and contain issues.

  4. Booklets that are reviewed and do not contain issues.

  5. Returned booklets

  6. Frozen booklets.

• ...then sorted by date, most recently changed booklets first.

• ...then sorted by subject ID.

• ...then sorted by booklet name.

• Previous
• Next