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; required fields are marked with an asterisk (*).
Main › Details
| Protocol No. * | Unique official protocol identifier from the sponsor or investigator. No spaces allowed. SBU investigator-initiated studies use an SBU- prefix (e.g., SBU-BREAST-VTE). |
| NCT Number | The NCT ID from ClinicalTrials.gov, including “NCT” (e.g., 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 › Management
| 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 (e.g., 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 — required for reporting and integrations, and for user access to the protocol. |
| Flowcharts | Not currently in use at Stony Brook. |
Need help?
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