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. - How are subjects selected for targeted source data verification?
If your study only requires partial source data verification (SDV), then you might opt for configuring targeted SDV and create a partial SDV strategy. This configuration defines a specific number of subjects randomly selected at a site and the specific questions that a Clinical Research Associate (CRA) must verify. - How do changes in Source Data Verification settings impact a study?
The Source Data Verification (SDV) settings can be updated at any time. This includes the study level settings to either include or exclude screen failed subjects, or to require different levels of SDV (full, targeted or none). For targeted SDV, you may also update the SDV strategy associated with a site or the SDV settings for a specific question in form design. - 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)