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Sites

Overview

Site entities represent the physical study site location where subject enrollments and data collection will take place. This same site will also be available in other areas of the system, such as adding to certain user configurations to establish site data restrictions, associations on volunteer records, and use within study setup and cohort management workflows.

Sites are expected to be setup and used as global entities. They exist with the purpose/expectation of being established and maintained across one or more studies.

Sites are added via the Administration > Sites component.

If a site is expected to participate in one or more studies, that site should not be created multiple times in Administration > Sites. Instead, the site would simply be added to study configurations established where that site is participating.

Sites are added to individual studies and managed via the Study > Configure component.

Permissions for adding sites

For our early phase customers, sites can only be added by ‘superadmin’ users through the assistance of our support team via service desk ticket. This is by design, due to the potential cost implications for adding and collecting study data against external (non-core) sites. More details about those costs are noted here: ClinSpark Pricing | ClinSpark Extra

For our customers who use ClinSpark setup for an operational model supporting later-phase multi site trials, users with the Administration > Sites role action on their account will be able to add sites without ‘superadmin’ intervention. We have a more detailed guide for our customers who setup and use sites for this purpose: Setting Up Sites

Sites are also only allowed to be added into a ‘MAIN’ environment (such as PROD MAIN). Sites cannot be added into any environments that are running in Test Mode. Through study design import functionality, sites are added and synchronized into matching TEST environments. Site attributes remain in synch between MAIN/TEST environment through the import mechanism over time. More details about this process are here: ❗Notes on Study Design Export and Import | Site configurations

Site details

When setting up a new site, these are our recommendations:

  • Fill out as much of the site details as possible including address, phone, and investigator details. Once a site has been added to a study configurations, the investigator details can be modified per study.

  • Always select a timezone setting that appropriately matches the physical location (closest city or region).

  • Establish height/weight unit of measure appropriate to the site geographic location.

  • Ensure proper volunteer display patterns to meet site regional privacy laws.

 

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