What does "going live" mean in EDC/CDMS?
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"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 your study to live in Castor EDC/CDMS, please consider the following:
- Modifying Study Forms: Once the study is live, direct modifications to study forms are restricted. To make changes, you must set the study status to 'not live'. Exercise caution when altering forms post-launch, as such changes will affect existing participants and may impact previously collected data.
- Thorough Testing Recommended: It's advisable for you and your team to comprehensively test the electronic Case Report Form (eCRF) before going live. This testing should encompass all study components, including participant randomization. If you intend to test randomization, ensure this is completed prior to setting the study live for the first time.
- Data Removal Restrictions: After the study is live, permanently deleting study data is not possible in adherence to Good Clinical Practice (GCP) standards. For instance, participants cannot be deleted but can be archived instead. Archived participants are excluded from exports and do not influence your study, but remain traceable and recoverable for auditing purposes. The same applies to survey invitations.
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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.