Review Status

  • Published by Viedoc System 2024-03-19
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Review status

You can sort the data to focus on the review status by country, site, event, subject, or form, with the following columns showing, respectively:

by Country

  • Study, Country
  • Percentage (%): CR, DM, SDV, Sign, Lock
  • Count (n/N): CR, DM, SDV, Sign, Lock
  • # of subjects

by Site

  • Study, Country, Site Code, Site Name
  • Percentage (%): CR, DM, SDV, Sign, Lock
  • Count (n/N): CR, DM, SDV, Sign, Lock
  • # of subjects

by Event

  • Study, Country, Site Code, Site Name, Event
  • Percentage (%): CR, DM, SDV, Sign, Lock
  • Count (n/N): CR, DM, SDV, Sign, Lock
  • # of subjects
    Rows in the report are ordered according to the events of the latest effective design.

by Subject

  • Study, Country, Site Code, Site Name, Subject
  • Percentage (%): CR, DM, SDV, Sign, Lock
  • Count (n/N): CR, DM, SDV, Sign, Lock

by Form

  • Study, Country, Site Code, Site Name, Subject, Event, Event Sequence, Event Date, Form, Form sequence, Clinical Review By, Clinical Review Date
    Rows in the report are ordered according to the events of the latest effective design.

n/N = number of forms reviewed for a specific status / total number of forms it is possible to review for a specific status.

Notes!

  • Event Date is not included in the Form Status, but it is included in the Review Status. This means that N in the review status is greater than the number of triggered forms, for example, in the form status.
  • For SDV, N is the total number of forms where SDV is possible. The N for other statuses counts the total number of forms as they apply to all forms.
  • Forms that have partial items selected for SDV will display as blank, instead of Not required, in case SDV is pending.


CR Percentage (%)

Sub report Description
Country The percentage of the initiated forms that have been reviewed of the initiated forms that can be reviewed. (Hidden forms are not considered).
Site
Event
Subject

DM Percentage (%)

Sub report Description
Country The percentage of initiated forms that have been data reviewed of the initiated forms that can be data reviewed. (Hidden forms are not considered).
Site
Event
Subject

SDV Percentage (%)

Sub report Description
Country The percentage of initiated forms that have been source data verified of the initiated forms that can be source data verified. (Hidden forms are not considered).
Site
Event
Subject

Sign Percentage (%)

Sub report Description
Country The percentage of initiated forms that have been 'signed' of the initiated forms that can be 'signed'. (Hidden forms are not considered).
Site
Event
Subject

Lock Percentage (%)

Sub report Description
Country The percentage of initiated forms that have been 'locked' of the initiated forms that can be 'locked'. (Hidden forms are not considered).
Site
Event
Subject

CR Count (n/N)

Sub report Description
Country n = Clinical reviewed forms.
N = The total number of initiated forms where CR is required (hidden forms are not considered for CR).
Site
Event
Subject

Note! n/N = number of forms reviewed for a specific status / total number of forms it is possible to review for a specific status.

DM Count (n/N)

Sub report Description
Country n = Data reviewed forms.
N = The total number of initiated forms where DM is required (hidden forms are not considered for DM).
Site
Event
Subject

SDV Count (n/N)

Sub report Description
Country n = Source data verified forms.
N = The total number of initiated forms where source data verification is required, either for the entire form or at least one item on the form.
Site
Event
Subject

Sign Count (n/N)

Sub report Description
Country n = Signed forms.
N = The total number of initiated forms where Sign is required (hidden forms are not considered for Sign).
Site
Event
Subject

Lock Count (n/N)

Sub report Description
Country n = Locked forms.
N = The total number of initiated forms where Lock is required (hidden forms are not considered for Lock).
Site
Event
Subject

# of Subjects

Sub report Description
Country The total number of subjects.

Site

Event

Reviewed Item

Description
Event A reviewed item will display an event, if the review action was performed on the event date.
Form A reviewed item will display a form, if the review action was performed at the form level.

Clinical Review By

Description
The Username and ID of the user who performed the clinical review.

Note! In the case where the event date form is excluded from Viedoc Clinic, then in Viedoc Reports - Review Status report, the 'Clinical Review by' will be marked as "N/A" (not applicable) since the form cannot be signed.

Clinical Review Date

Description

The date and time in UTC (Universal time coordinated) when the clinical review was performed.

DM Review By

Description

The Username and ID of the user who performed the data review.

Note! In the case where the event date form is excluded from Viedoc Clinic, then in Viedoc Reports - Review Status report, the 'DM Review by' will be marked as "N/A" (not applicable) since the form cannot be signed.

SDV Review Date

Description

The date and time (UTC) when the data review was performed.

SDV By

Description

The Username and ID of the user who performed the source data verification (SDV).

Note! In the case where the event date form is excluded from Viedoc Clinic, then in Viedoc Reports - Review Status report, the 'SDV by' will be marked as "N/A" (not applicable) since the form cannot be signed.

SDV Date

Description

The date and time (UTC) when the SDV was performed.

Signed By

Description

The Username and ID of the user who signed the form.

Note! In the case where the event date form is excluded from Viedoc Clinic, then in Viedoc Reports - Review Status report, the 'Signed by' will be marked as "N/A" (not applicable) since the form cannot be signed.

Signed Date

Description
The date and time (UTC) when the form was signed.

Locked By

Description

The Username and ID of the user who locked the form.

Note! In the case where the event date form is excluded from Viedoc Clinic, then in Viedoc Reports - Review Status report, the 'Locked by' will be marked as "N/A" (not applicable) since the form cannot be signed.

Locked Date

Description
The date and time (UTC) when the form was locked.

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Notes!

  • Event Date is not included in the Form Status, but it is included in the Review Status. This means that N in the review status is greater than the number of triggered forms, for example, in the form status.
  • For SDV, N is the total number of forms where SDV is possible. The N for other statuses counts the total number of forms as they apply to all forms.
  • Forms that have partial items selected for SDV will display as blank, instead of Not required, in case SDV is pending.