Understand site, depot, and lab management

Learn more about the terminology and workflows in managing your sites, depots, and labs at both the study and global levels.

Required roles to work with this feature

This feature may impact all users who work with sites, depots, labs, or administrate a study in general. Users responsible for managing organizations and their contacts at the global level should be assigned the following roles:
  • Global user managers
  • Site administrators
  • Study managers
  • Clinical supply managers
  • Manage contacts and organizations
  • View contacts and organizations

Defining and using a primary address

Note:

Keep in mind that at least one address is required and must be selected as the main primary address.

Creating a primary address allows you to manage a recurring address throughout your studies in one place, ultimately reducing the amount of places you update it. Because this address is the first entered in the system for your study, it becomes the default primary address. When specifying details in any Addresses section, you have the ability to copy the primary address into other address fields, such as Billing or Shipping.

For more details and field descriptions for primary addresses, see Specify a reusable address for your organization and contacts.

Manage your study's contacts and organizations

When managing your contacts and organizations at the global and study levels, you should know the following:

  • All sites and depots are created at a global level, but can still be added at the study level, as well. Their addresses and associations with specific contacts and studies are maintained only at the global level.
  • Depots or lab facilities can be created at the study level. Furthermore, you can associate a local lab with a site at the study level.
  • You are not required to transfer or retire existing studies when a contact's or organization's status has been updated to Restricted or Retired.
  • When managing an institution:
    • If a study level site or depot is retired and the global level institution or depot is retired, the study level site or depot cannot be activated until the global institution or depot is activated.
    • Retiring an institution at the global level only allows for a site at the study level to be transferred or retired. Furthermore, a depot or lab cannot be transferred or retired regardless of their associations.
    • If an institution has a contact associated with it, its site can be transferred or retired.
    • Existing associations remain tied to the retired or restricted institution.
  • When managing a vendor (lab):
    • Transferring a lab migrates the study level sites to the new vendor that has been selected from other available vendor labs.
    • Retiring a lab at the global level does not allow the lab to be used for future sites. The existing sites at the study level continue to be tied to the now retired lab and its data.
    • Existing associations at the global level remain tied to the retired or restricted lab.
  • When managing a vendor (depot):
    • Transferring a depot migrates the study level sites to the new vendor that has been selected from other available vendor depots.
    • Depots are only able to be transferred to another depot when retired from the global level. Retiring a depot at the study level only retires it from the study, and it cannot be transferred to another depot.
    • Existing associations at the global level remain tied to the retired or restricted depot.

Understand this feature's terminology

Term Description Details
Primary Address The main primary address that is associated with the contact or organization that you create. Any updates made to a contact's primary address does not impact any of their other associated addresses (billing address, shipping address,secondary address), even when these other addresses are the same as the primary one. Other addresses associated with a contact must be manually updated.
Contact Investigator: An individual responsible for or partaking in conducting a clinical study at a site.
  • A single contact can be associated with multiple institutions.

  • For every contact that you create, you must specify any required information and their addresses. A contact can have multiple types of addresses such as a primary address, billing address, shipping address, or an alternate address.

    A contact's address(es) can be deleted if not being used at the study level.

  • A contact can be deleted if it has never been used in a study.

  • You can add the date of retirement or death when marking an investigator as Retired or Deceased.

    An investigator is not selectable in a study if they have been marked as Retired or Deceased.

  • Any updates made to a contact's existing data at the global level will automatically update at the study level.
For step-by-step instructions on contact management, see:
Organization Institution: A facility in which a clinical study is developed and conducted at.
  • Hospital: An environment that provides medical services assisting in clinical studies.
  • Teaching Hospital: A hospital that is affiliated with a medical school.
  • Medical Clinic: A medical facility that provides outpatient services.
  • Other: A facility outside of the others listed.
Vendor: A company or organization that provides services to sponsors of clinical studies.
  • Lab:
    • Local: A lab facility that may be present at the site or a nearby location.
    • Central: A lab facility that processes data and specializes in testing.

    For step-by-step instructions on creating lab type of vendor, see Create a vendor (lab).

  • Depot: A facility that manages and distributes supplies, such as medications, during a clinical study.

    For step-by-step instructions on how to create a depot type of vendor, see Create a vendor (depot).

  • For every organization that you create, you must specify any required information, as well as their addresses. An organization can have multiple types of addresses, such as a primary address, billing address, shipping address, or an alternate address.

    An organization's address(es) can be deleted if not being used at the study level.

  • For an institution, you can also create departments to better organize the hierarchy and workflows at that specific organization.
  • When creating an institution, you can associate a contact with that institution, and then assign that institution to a study and a specific study mode at your organization. This creates a site that becomes available in the studies.
For step-by-step instructions on organization management, see:
Statuses for contacts and organizations For more information on what each status entails, and step-by-step instructions on how to update the status of a contact or organization, see Update the status of a contact.
  • When a status other than Active is selected for a contact or organization, the system ensures that no active studies are associated with the contact or organization.

    If you update the status of a contact or organization that is associated with an active study, see Transfer active contacts or Transfer active organizations.

  • Contacts and organizations cannot be set to Restricted if they have not been used in a prior study. Furthermore, if a contact or organization has been set to Restricted, it cannot be selected in a study until it has been set back to Active.

Parent topic: Create and manage institutions, vendors, and contacts