Site, depot, labs, and source data verification FAQs
- About depot-to-depot shipments
Depot-to-depot shipments offer full traceability of kits used within a study, so it is important to understand a user's role in the lifecycle of a depot shipment. - I'm ready to go live. What do I need to do with sites?
Assign a study version to each site, and then activate the sites. After you activate a site, the site can start collecting data, so don't activate a site until you're ready for the site to go live, such as after all contracts have been signed. - Understanding source data verification
Targeted source data verification (SDV) allows you to tailor the level of data verification to each study and to each site within the study. Before creating your targeted SDV strategy, be sure to understand what your settings mean in terms of real world data collection. Reviewing some common scenarios can help. - How are subjects randomly selected for targeted source data verification?
If your study only requires partial source data verification, then you might opt for creating a partial source data verification strategy, which would guide Clinical Research Associates (CRAs) to verify the data of certain subjects and specifically-marked questions at a site, by a study designer. - If a site is involved in more than one study, do I need to create multiple instances of the site?
No. You can create a site in a study, and then you can add it to any other study without having to re-enter details about the site. - If a depot is involved in more than one study, do I need to create multiple instances of the depot?
Yes. You must define the depots for each study individually. - What is the workflow for creating and managing local labs?
The following steps outline key tasks for creating and managing local labs, whether you're a study designer, a data manager, or another user at a sponsor organization assigned with creating and managing laboratories in a study.
Parent topic: Frequently Asked Questions (FAQs)