| Oracle® Health Sciences Network User's Guide Release 2.0.0.0 E35514-02 |
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A provider organization that contributes their patient data to the HSN network. These organizations enter into relationships to provide counts of matching patients (responding to Protocol criteria) and for patient recruiting activities (that is, the Patient Recruiter service).
A collection of inclusion and exclusion logic statements, which defines the patient population (or cohort) that is eligible to participate in a Protocol. Each Protocol is expected to be associated to a defined set of Eligibility Criteria
Typically they are DM customers who load their de-identified clinical data into the Health Sciences Network. Customers of this service own their data that they load into Oracle managed systems. Oracle service is only used to load and manage the data and provide them capabilities to give other participants in the network access to their data to perform protocol validation and patient recruitment. Some providers in the network can also be PV and PR customers if they have investigator lead clinical studies to execute.
An organization that has registered for an HSN service with another HSN organization. For example, when a Sponsor and a DM Participant register as a collaboration with the Protocol Validator service, then each of these two organizations are partners.
Pharma, Medical Device, Biotech
They are PV and PR customers within the network. These customers enter into a separate contract with one or more DM customers inside the network to obtain access to their data to perform protocol validation and patient recruitment. Oracle provides network access only after these customers purchase the PV and PR services independently from Oracle. Oracle does not offer any assurance that DM customers will grant PV and PR customers access to their data.
The industry definition of a research study which is formalized in a document. Within HSN, a protocol is the entity that holds many key characteristics like "Title", "ID Number", "Purpose", "Target EnrolllmentEnrollment" and "Target Start Date", along with supporting descriptions or narrative that provide context for the protocol's requirements and objectives.
A healthcare organization (that is, hospital, hospital network, academic medical center) that cares for patients and manages patient health information.
An institution that funds or needs to execute a clinical study (that is, Pharmaceutical Company, Medical Device Company, AMC, CRO). These organizations enter into relationships to create and define Protocols to query for matching patients, and to engage with DM Participants, for support with patient recruiting.