System Management module

 

Changing the status of a study

To change the status of a study, you need the 'Change study status' permission

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

  2. Select a study and click the status button of your choice. The study status is changed.

Study statuses

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 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 open for subject recruitment and data collection.

This status is designed to protect subject data and avoid data corruption. You cannot:

  • Delete the study

  • Delete eForms, visits, questions or question groups

  • Remove questions from groups or eForms (even if a removed question is later replaced, this can still cause a problem)

  • Remove eForms from the schedule

  • Delete category values within a category question definition

  • Change category value codes within a category question definition

  • Change question types

  • Change the format of a question

  • Add or change question 'Reject if' validation conditions

For more info, see 'Changing an open study' in the SD help...

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 collection 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

 

The status of a study affects the actions that you can carry out. Only studies with the status of 'In Preparation' will allow you to overwrite existing subject data during a 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.

 

 

Related Topics

About studies

Viewing a list of studies