OnCore Dictionary

List of terms and acronyms commonly used in OnCore. 

Are we missing one?  Let us know via OnCore-Support@ahc.ufl.edu.

Term or AcronymDefinitionContext or Field Location
AccrualAn accrual is the count of subjects on a study. A subject is considered an accrual per the sponsor’s criteria, usually after consent, eligibility and any screening procedures are complete.Subjects
AdjuvantStudy drug is enhancing or otherwise affecting the impact of another drug or treatment.PC Console
AffiliateAnother institution or site that is conducting clinical trials where UF is the coordinating center. An Institution other than UF.PC Console
AgeIndicates the age of subject participants. Options are 'Adult', 'Children', or 'Both'.PC Console
AHCAcademic Health Center - represents any non-oncology part of UF. Also see Organizational Unit, Library, PC Console
Assigned SubjectsPatients can be assigned to study team members in OnCore.Subjects
Billing SlipVisit-level accounting of services provided that should be charged to the research study.Financials
BSM ConsoleRefers to the Biospecimen Management console in OnCore that has the capability to provide information regarding inventory tracking, requisition and distribution management, related document storage, and applicable reports.
CACoverage AnalysisFinancials
Cancer CenterUF Health Cancer Center
Companion StudyA study conducted in conjunction with at least one other study. Enrolling into the companion study can be either "required" or "optional"PC Console
Consent at Age of MajorityTriggers warnings to re-consent subjects at the age of majority when set to 'Yes'. This field is only active when the 'Age' selected is Children or Both.PC Console
ConsoleAn OnCore console is a set of related OnCore pages that are grouped for a particular workflow, function, or type of data.
Contact RecordsContact records can be created for any team members who need to be tracked in connection with a protocol, subject, task, audit, or registry. Contacts do not necessarily have access (see User Records).
Correlative StudyA correlative study looks at relationships between human biomarkers (e.g. genes, proteins) and something else (e.g. a disease, a treatment). In recent years many biospecimen-based biomarkers have been incorporated into cancer therapeutic trials. In OnCore, a correlative study may be associated with a main study, but does not seek the main outcomes of the main study.
CorrelativesBiomarker specimens for correlative studies.
CRAClinical Research AdministrationCRA Console
CRMClinical Research Management
CRMSClinical Research Management System
CROContract Research Organization or Clinical Research Organization - A company hired by another company or research center to take over certain parts of running a clinical trial. The company may design, manage, and monitor the trial, and analyze the results.
CRPCClinical Research Process Content – an Epic-OnCore interface that allows OnCore calendar and billing grid data to flow from OnCore to Epic.
CTCAECommon Terminology Criteria for Adverse Events – The NCI CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting.
CTGClinical Trials Group (Oncology)
CTMSClinical Trial Management System
CTOClinical Trial Office at the UF Health Cancer Center
CTRPNCI's Clinical Trials Reporting Program
CTSIClinical and Translational Science Institute
Data Table 4An NCI report that shows the clinical research trials that are open during a 12 month period at an institution. The report includes data on study type, sponsor type, principal investigator, accruals, etc.
DepartmentIdentifies the institutional funding body for the study. Fiduciary reporting is available based upon this field. Additionally, the permission scope of Department is driven off of this field. PC Console
DeviationA variance from the approved protocol procedures.Subjects
Drug AccountabilityIndicates whether drugs are being used and recorded within the protocol. Options are 'Yes', 'No', or 'N/A'. This is an information-only field and does not drive any OnCore functionality. Not a required field at UF.PC Console
DSMBData Safety Management Board
EMRElectronic Medical Record
Enrollment ScopeThe general pools into which participants may be enrolled - can be "local", "national", and "international".
EpicUF Health Shands Hospital’s electronic medical record system.
ePRMSElectronic Protocol Review and Monitoring System. Also see Protocol Review and Monitoring System.
FCFinancial Coordinator RoleAccess
FEDFederal Rate BaseFinancials
HSCHealth Science Center at UF
ICFInformed Consent FormPC Console, Subjects
IDCIndirect Charges – Overhead costs, Indirect Costs (IDC), and Facilities and Administrative (F&A) costs are terms have been used interchangeably by the federal government as equivalents to describe the same concept. These are actual costs incurred by the university in support of sponsored activities that cannot be identified readily and specifically to a project. Among other expenses, it includes the cost of departmental and central administrative support, building and equipment use, and library services, etc.Financials
IDEInvestigational Device ExemptionPC Console
IHEIntegrating the Healthcare Enterprise
INDIndustry Rate BaseFinancials
INDInvestigational New Drug ApplicationPC Console
InstitutionInstitutions are the logical business units of clinical trials that participate in a protocol.PC Console
INVInvestigator Initiated Rate BaseFinancials
Investigator Initiated ProtocolIndicates whether the principal investigator initiated the protocol; options are 'Yes', 'No', or blank. This field is used in the Data Table 4 Revised -- Clinical Research Protocols report.PC Console
IRBInstitutional Review Board, a group of scientists, doctors, clergy, and consumers that reviews and approves the action plan for every clinical trial.PC Console
LibraryDetermines the Reference Codes, Forms, Protocol Annotations, Notifications and Signoffs available for the protocol. This field cannot be changed once the status of the protocol has changed from 'New'. There are two libraries in UF OnCore: Oncology and Academic Health Center (non-oncology).PC Console
MRNMedical Record NumberSubjects
NCINational Cancer Institute
NCT NumberNational Clinical Trials Number in ClinicalTrials.govPC Console
ObjectivesIdentifies the objective for the protocol according to your institution's SOPs. Objectives populate to the SIP Console and display on the public website.PC Console
OnCore AdministratorThe staff assigned to maintain the OnCore database.OnCore-Support@ahc.ufl.edu
Organizational UnitOrganizational Units are used to organize protocols into logical structural divisions, which is useful for reporting purposes and to restrict access to protocols. The permission scope of Organizational Unit is driven off of this field. At UF, we have two OUs: Cancer Center or Academic Health Center .PC Console
OUSee Organizational UnitPC Console
PCProtocol Coordinator RoleAccess
PC ConsoleThe PC Console displays information about one protocol at a time: details that might be of interest to a Protocol Coordinator. The PC Console includes the protocol number and title, the type of study, the staff assigned to the protocol, the protocol sponsor, and other protocol-related information.PC Console
PDQPhysician Data Query
PhaseIndicates the study phase of the protocol. The phase selected here populates to the SIP Console and displays on the public website. Protocol Search provides a Search By Phase option.PC Console
PIPrinciple Investigator. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.PC Console
PRMCUF Cancer Center Protocol Review and Monitoring Committee. At UF this is also called the Scientific Review and Monitoring Committee (SRMC).PC Console
PRMC CoordinatorThe Protocol Review and Monitoring Committee Coordinator manages the PRMC meeting agendas, tracks submissions, tracks committee decisions, and manages communications between the investigators and the PRMC. PC Console
PRMSProtocol Review Meeting System for Cancer studies.PC Console
Protocol No.A unique, automatically-generated protocol identifier in OnCore.PC Console
QCTQualifying Clinical TrialFinancials, Covergae Analysis
RCResearch Center
Reference CodesValues that populate drop-down fields throughout OnCore.Coverage Analysis
RRRe-consent Required - used to indicate a re-consent requirement for enrolled subjects.Subjects
SAESee Serious Adverse EventSubjects
SCStudy Coordinator RoleAccess
ScopeIndicates the enrollment scope. Typically, 'Local' indicates the trial will only be open for the research center, 'National' indicates a multi-institutional trial. This is an information-only field and does not indicate scope for Data Table 4 reporting or any other functionality.PC Console
Serious Adverse EventAny untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or requires medical or surgical interventions to prevent any of the above outcomes.Subjects
Short TitleContains abbreviated version (100 characters maximum) of the protocol title. The short title entered here populates to other screens within OnCore and is displayed in some reports. The Short Title and Title both populate to the SIP Console.PC Console, SIP Console
SpecificationsThe base template for a OnCore study calendar.Calendars
Specimen BankingUsing the OnCore BioSpecimen Management system (BSM)PC Console, BSM Console
SponsorOrganization or company supporting the trial, including financial, drug supply, data management, etc.PC Console
StaffList of team member contacts for the protocol.PC Console
Study Information Portal (SIP)Study Information Portal public website. Note: UF currently offers this through the CTSI study portal, not the OnCore SIP portal.SIP Console
Study SiteLocation associated within an Institution where subjects will be treated. In UF OnCore, UF has two study sites: UF Gainesville and UF Jacksonville.PC Console
SubmitterThe staff (on behalf of a Principal Investigator) entering and submitting a new protocol and associated documents to the PRMC (Protocol Review and Monitoring Committee) or OCR for review.Staff Role
Summary 3An NCI report that shows patient accrual data for a 12 month period at an institution. The report includes data on cancer site, demographics, etc.
Summary AccrualOnCore protocols can be set up so that patient accrual data is entered periodically “in bulk” rather than as individual patient registration and subject visit tracking. Summary Accrual protocols typically do not have a visit calendar set up.PC Console
TitleIdentifies the full-length name of the protocol. The title populates to other pages within OnCore and is displayed in some reports. It is the only title used on the NCI Data Table 4 report. The Title and Short Title both populate the SIP Console.PC Console, SIP Console
ToleranceVisit WindowCalendars
ToxicityRefers to harmful side effects caused by the agent or intervention being tested.
Treating PhysicianThe physician that is treating the subject while they are on the study.Staff Role
User RecordUser Records are activated for team members who need to log into OnCore.Access
User RoleRoles are sets of permissions granted to OnCore users. A user can have multiple “stacked” roles. The permissions in a user’s role(s) determine the tools, consoles, and pages within OnCore that the user can access. Examples of how a particular role might be set up:
• FC - Financial Coordinator has update access to FC Console but cannot see subject data.
• PC - Protocol Coordinator has update access to the PC Console but cannot see any financial data.
• PI - Principal Investigator has view-only access to his/her protocols and subjects.
• RC - Regulatory Coordinator has access to regulatory pages in OnCore.
• SC - Study Coordinator has update access to protocols and subjects assigned to them.