Terms and abbreviations listed here are commonly used in the OnCore system and/or by OnCore Support, and definitions are provided to help the OnCore user community.
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Commonly used clinical trial acronyms can be found here.
Terminology
| Term | Definition |
|---|---|
| Additional visits | Visits which are related to the protocol but are not assigned a time point in the calendar. May also be called Unscheduled Visits. |
| Anchor dates | Dates entered into OnCore which drive the calendar to open/close segments. See Anchor Date Types below. |
| Billing designations | Indicates how a procedure will be billed. Appears as “M” (Medicare) or “S” (Sponsor) in the OnCore calendar. M indicates that it will be billed to patient/insurance. S indicates it will be paid for by the Sponsor. |
| Calendar validation | Study team review of OnCore calendar before release. |
| Management Group | A Management Group belongs to an Organizational Unit (OU) and represents a smaller team, usually focused on a research/clinical specialty or administrative area within the OU. At the University of Arizona Cancer Center, Management Groups (also called Disease Teams) include BMT/Leukemia, Breast Cancer, Central Nervous System, Children’s Oncology, Cutaneous Oncology, Gastrointestinal, Genitourinary/Renal, Gynecological Oncology, Head and Neck, Lung, Lymphoma, Melanoma, Pediatric Oncology, Phase I, Precision Medicine, Prevention, Radiation Oncology, and Sarcoma. |
| Optional segments | Segments of the OnCore calendar which may only apply to certain arms. If needed, must be selected on the Subject calendar page. |
| Sequence number | Patient/Subject identification number, often assigned by sponsor. |
Anchor Date Types
| Name | Definition |
|---|---|
| Consent Signed | Date the subject signs consent |
| On Study | • IIT (Randomized): Date treatment is assigned • IIT (Non-Randomized): Consent signed date • Industry: Date subject is registered • Cooperative Group: Date subject is registered |
| On Arm | Date treatment is assigned |
| On Treatment | Day one of treatment |
| Off Treatment | Date the subject stops all study drugs/device(s) |
| Off Arm | Date the subject finished Arm-related procedures and events |
| On Follow-Up | Date subject begins Follow-Up or Pre-Progression Follow-Up (for Oncology studies) or Day after Off Treatment date |
| Date of Progression | Date subject progresses (for Oncology studies) |
| Off Study | Date subject's participation ends and no more data will be collected. All expired subjects must have an Off Study date (for Oncology studies). |
Abbreviations
| Abbreviation | Meaning |
|---|---|
| AE | Adverse Event |
| BHRF | Banner Health |
| COI | Conflict of Interest |
| CRC | Clinical Research Coordinator |
| CRF | Case Report Form |
| CTMS | Clinical Trial Management System |
| DOB | Date of Birth |
| DSMC | Data Safety Monitoring Committee |
| ICF | Informed Consent Form |
| IIT | Investigator Initiated Trial |
| IRB | Institutional Review Board |
| LTFU | Long-Term Follow-Up |
| MRN | Medical Record Number |
| OTA | Open to Accrual |
| OU | Organizational Unit |
| PHI | Protected Health Information |
| PRMS | Protocol Review and Monitoring System |
| RIA | Research Intake Application |
| SAE | Serious Adverse Event |
| SIV | Site Initiation Visit |
| SRC | Scientific Review Committee |