What does "going live" mean in EDC/CDMS?
"Going live" in essence means that your study is 'in progress' and you can start collecting data. When the study is not live only users with at least one management right can access it. Once live, users you have invited to your study will be able to access it, depending on their respective assigned rights. Here you can learn how to set your study live.
Before setting the study to live, consider the following consequences:
While the study is live, it is not possible to directly make changes to your study forms. If you need to make such changes, the study must be switched to 'not live'. Please note that care should be taken when making changes after going live, as changes will be reflected in already existent participants and might affect existing data.
We recommend that you and your team thoroughly test your eCRF thoroughly before going live to ensure that everything works as expected. This includes randomization of participants - if you want to test the randomization, this should be done before going live for the first time.
Be aware that after going live, removing study data will no longer be possible in accordance with Good Clinical Practice (GCP) standards. For example, participants can not be deleted and will need to be archived instead. Archived participants will not get exported nor influence your study in any way, but will still be traceable/recoverable in case of an audit. The same applies for survey invitations.
When the study is set to live, you will be shown the price for your study and receive an invoice. The price of the study is based on the information you enter in the 'study details' form. It is important to fill out this form truthfully and as completely as possible.
You will also receive the full pricing overview by email after you set your study to live for the first time. In case you have received a billing code e.g. if you are from a site with a site license for Castor, you will need to enter this in the billing code details section of the 'Settings' tab.
What happens when I change the study to 'not live' again?
Setting your study offline is necessary for example if you have completed your study or if you need to make changes to your forms while your study is running. Changing the study to 'not live' means that any users without management rights will not be able to access the study for the duration of time that the study is not live. Taking your study offline will not affect your study or your collected data in any way.