These are the field definitions for the OnCore PC Console Main tab, covering both the Details and Management sections. Guidance below reflects Stony Brook School of Medicine conventions.
Fields marked with an asterisk (*) are required. Not sure what to enter? Email OnCore Support.
Main tab: Details
| Field | What to enter |
|---|---|
| Protocol No. * | Unique official protocol identifier from the sponsor or investigator. No spaces allowed. SBU investigator-initiated studies use an SBU- prefix (for example, SBU-BREAST-VTE). |
| NCT Number | The NCT ID from ClinicalTrials.gov, including “NCT” (for example, NCT06230185). Leave blank if pending; investigator-initiated trials may not have one. |
| Library * | Select Medicine for non-oncology trials. |
| Department * | Select School of Medicine for non-oncology trials. |
| Organizational Unit * | Select School of Medicine for non-oncology trials. |
| Title | Full study title; should match the official ClinicalTrials.gov title where applicable. |
| Short Title | Abbreviated title; try to match the ClinicalTrials.gov short title where applicable. |
| Objectives | Populates public clinical-trial listings. Default to the ClinicalTrials.gov Purpose/Brief Summary; otherwise a brief description with at least the primary objective. Check pasted text for spacing or line-break issues. |
| Phase * | Non-oncology interventional studies: I, II, III, or IV. Use N/A for behavioral, pilot, device, or other biological studies. |
| Scope | National or Local. Local protocols are open only at Stony Brook or its affiliates. |
| Age | Inclusion age category: ADULTS (18+), CHILDREN (under 18), or BOTH. |
| Consent at Age of Majority | Yes if children must reconsent at 18; otherwise No. Active only when Age is Children or Both. |
| Drug Accountability | Yes if drugs are study-supplied; No if only standard-of-care/commercial supply; N/A if no drugs. |
| Investigator Initiated Protocol? | Yes if written by a Stony Brook investigator, regardless of funding source; otherwise No. |
| Involves Therapy | Yes for a therapeutic intervention (treatment or supportive care); otherwise No. |
| Exclude Protocol on Web | Check to keep the protocol out of public trial listings. In general, interventional trials should appear on the web. |
| Open for Affiliates Only | Yes if the protocol opens for accrual at affiliate sites but not at Stony Brook. Rarely Yes. |
| Summary Accrual Info. Only | No when individual subjects are registered (required for all interventional trials). Yes only when collecting aggregate summary data. |
| Protocol Type * | Select the type: Basic Science, Device Feasibility, Diagnostic, Health Services Research, Prevention, Screening, Supportive Care, Treatment, or Other. |
| Registration Center | Select SOM Clinical Trials Office (SOMCTO) for School of Medicine trials. |
| Involves Correlates or Companions | Yes if the protocol has companion studies in OnCore or tracks correlative specimens; otherwise No. |
| Data Monitoring | Party responsible for data monitoring: DSMC (internal), External DSMC (industry/cooperative-group), or PI. |
| Adjuvant | Yes if the study drug enhances or affects the impact of another drug. |
| Includes Specimen Banking? | Yes if the study includes specimen banking; otherwise No. |
| Companion Study? | Check if this protocol is a companion to another study. |
| Multi-site Trial | Yes if two or more distinct study sites (always Yes for national studies; No only if Stony Brook-only). |
| Investigational Drug | Yes if an investigational drug is used; otherwise No. |
| Investigational Device | Yes if an investigational device is used; otherwise No. |
| Precision Trial | Yes for trials with biomarker-defined targets and molecularly selective agents. |
| Precision Trial Classification | Basket, Umbrella, Targeted, or Other Adaptive Trials. |
| Pilot | Whether the study is a pilot phase (Yes/No). |
| Rare Disease | Whether the protocol is rare disease (Yes/No). |
| Certificate(s) of Confidentiality | Yes/No. Choose Yes for NIH studies. A CoC generally protects a researcher from being compelled to disclose identifiable, sensitive research information. |
| Pragmatic Trial | Yes/No/blank. A pragmatic trial evaluates effectiveness in real-world clinical settings rather than ideal conditions. |
| Exclude Protocol from Analytics | Leave unchecked. |
| Accrual – Not Applicable | When checked, N/A appears for all target-accrual and accrual-goal fields. |
| Protocol Target Accrual | Total subjects to enroll at all sites. |
| RC Total Accrual Goal (Lower) | Minimum subjects to enroll at our site (may be in the contract). |
| RC Total Accrual Goal (Upper) | Maximum subjects to enroll at our site; account for consented screen failures. |
| RC Annual Accrual Goal | Expected subjects per year at our site, based on the lower goal and accrual duration. |
| Affiliate Accrual Goal | Total subjects at our affiliates; leave blank if not collaborating with affiliates in our OnCore. |
| Accrual Duration (Months) | Estimated months to complete enrollment. |
| Primary Completion Date | Actual or estimated date the final subject is examined/receives intervention for primary-outcome data. Refer to ClinicalTrials.gov. |
| Study Completion Date | Date data was or is expected to be collected. Refer to ClinicalTrials.gov. |
Main tab: Management
| Field | What to enter |
|---|---|
| IRB No. | The IRB number assigned by the Stony Brook University IRB. |
| Pharmacy No. | Not required. Holds a pharmacy-assigned protocol number if applicable. |
| Priority Score | Not required. An information-only numeric score, typically from scientific review; drives no functionality. |
| DSMC Review Frequency (months) | Auto-calculates a re-review date. Enter months between reviews, create a DSMC review with an empty Re-review Date, and Submit. Not required. |
| CRC Participation | Yes if using a Stony Brook Clinical Trial Unit for research visits. |
| CRC No. | Not required. Leave blank. |
| CRC Approval Date | Not required. Leave blank. |
| CRC Category | If using a Clinical Trial Unit, select the site(s) you will use. |
| Comments | Not required. Information-only; drives no functionality. |
| Coding Scheme | Do not change the pre-selected scheme. Determines the option list for AE/SAE reporting. |
| Generate MRN | Set to No. Not permitted without prior approval. |
| Automated Sequence No. | Auto-generates a subject sequence number. Options: Yes, No, Randomization Block, or Stratification Block. |
| Internal Account No. | Not required. Records other internal tracking numbers used by your team. |
| Hospital Account No. | Not required. Leave blank. |
| Allow Duplicate Enrollment? | When checked, a subject can be added multiple times; each On Study date counts as a separate accrual (for example, re-screen and re-enroll). |
| Allow On Treatment before On Study | Allows an On Treatment date before the On Study date. Uncommon. |
| Populate On Follow-Up Date with Off Treatment Date | When checked, Follow-Up Start Date auto-populates from Off Treatment Date; it can be removed if needed. |
| Administrative Groups – Management Group | Select the study’s Management Group (usually the PI’s department). Always check Primary for the primary group, even if only one is selected. This is required for reporting and integrations, and for user access to the protocol. |
| Flowcharts | Not currently in use at Stony Brook. |