System Management module

 

Changing the status of a study

To change the status of a study, you need the 'Change study status' permission. This feature has a database-wide scope.

Study statuses

The status of a study affects the actions that you can carry out. There are five statuses, which reflect the different stages in the lifespan of a study:

 

Status

Description

Effects

In Preparation

Used to signify that a study is still in the preparation stages and that data collection has not yet begun. This is the default status and can only be reinstated from an Open study. This is the only status that allows you to overwrite existing subject data during a subject data import.

This status allows you to carry out all tasks. Note that if you delete items such as questions or eForms from the study definition this will corrupt any existing data.

This status is not designed to be applied to a live study.

Open

Used to signify that a study is live (open for subject recruitment and data collection).

This status is designed to protect subject data and avoid data corruption. There are strict restrictions on the tasks you can perform on an open study.

Suspended

Used to signify that data collection and data review have been suspended.

You cannot:

  • Delete the study

  • Create a new subject

  • Carry out any data entry/review tasks including SDVs, DCR, notes, freezing or locking

  • Overwrite existing subject data during subject data import

Closed to Recruitment

Used to signify that no more subjects may be recruited into the study but that data collection for existing subjects may continue.

You can:

  • Edit existing subjects

You cannot:

  • Delete the study

  • Create a new subject

  • Overwrite existing subject data during subject data import

Closed to Follow Up

Used to signify that data can no longer be collected for any recruited subjects.

You cannot:

  • Delete the study

  • Create a new subject

  • Edit existing subjects

  • Overwrite existing subject data during subject data import

Viewing a history of status changes

  1. Select Tasks > Study > Status. A list of all the studies on the current database is displayed.

  2. Highlight a study and click History. The Study Status History screen is displayed, listing the study name and version, the new status, the code of the user who carried out the change, and the date and time of the change.

  3. Click a column heading to re-order the list according to the entries in that column.

Reporting

The Study List standard report gives details about the description, status and content of studies. More information...

 

 

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