OnCore: Subject Quality Control
Outline of the OnCore protocol related data field quality control, explanation and resolution guidance.
Subject Console sections
Demographics
| Query | Explanation | Resolution |
|---|---|---|
| Subject should be 18 years or older at the time of consent if PC Console > Age Groups is 'Adults'. Please check the Subject Console > Demographics tab > Birth date. | Verify that participant age is consistent with Age group selected. | OnCore: Adding UW-Madison Subjects (Epic MRNs) to OnCore Protocol |
| Missing Expired Date in Subject Console > Demographics tab. If Off Treatment Reason is Death then Subject Console > Demographics Expired Date should be entered. | This field automatically populates to the Subject Console > Demographics tab > Expired Date field. | OnCore: Adding UW-Madison Subjects (Epic MRNs) to OnCore Protocol |
| Missing Expired Date in Subject Console > Demographics tab. If Off Study Reason is Death then Subject Console > Demographics Expired Date should be entered. | This field automatically populates to the Subject Console > Demographics tab > Expired Date field. | OnCore: Adding UW-Madison Subjects (Epic MRNs) to OnCore Protocol |
Consent
| Query | Explanation | Resolution |
|---|---|---|
| Subject in Consented or Eligible status, but protocol is Terminated at the participating site. Update subject status to Consent Withdrawn or Not Eligible, as applicable. | The participant status of Off Study when all participating sites are Terminated | OnCore: Documenting Subject Informed Consent or Consent Refusal |
| 'Subject has Eligibility Date, but is missing Consent Date. Enter Consent Date in Subject Console > Consent Tab | Verify a Consent entry prior to documentation of eligibility. | OnCore: Documenting Subject Informed Consent or Consent Refusal |
Eligibility
| Query | Explanation | Resolution |
|---|---|---|
| Missing Eligibility Date in Subject Console > Eligibility tab. | This date should be the same or later than the consent date, or the same or prior to the on study date. | OnCore: Documenting a Subject's Eligibility Status |
| Subject Console > Eligibility tab > Eligibility Status is "Not Eligible" but On Study tab > On Study Date entered. Verify eligibility status. | Verify that eligibility status of Not Eligible should not be used with an On Study date. | OnCore: Documenting a Subject's Eligibility Status |
| Eligibility Date must be on or after Consent date | This date should be the same or later than the consent date, or the same or prior to the on study date. | OnCore: Documenting a Subject's Eligibility Status |
| Eligibility Date must be on or before On Study Date | This date should be the same or later than the consent date, or the same or prior to the on study date. | OnCore: Documenting a Subject's Eligibility Status |
On Study
| Query | Explanation | Resolution |
|---|---|---|
| Missing Sequence Number is Subject Console > On Study tab. |
Sequence numbers are mandatory for all subjects accrued in the database, and are required to have the same syntax per protocol for studies open to accrual as of 1/1/06.
|
OnCore: Documenting a Subject as ON STUDY |
| Missing On Study date in Subject Console > On Study tab. On Study Date should be entered if Off Study Date is entered. If subject did not go On Study remove the Off Study date. | The status of Off Study should only follow an On Study status. | OnCore: Documenting a Subject as ON STUDY |
Treatment
| Query | Explanation | Resolution |
|---|---|---|
| Missing On Treatment Date in Subject Console > Treatment tab. If the subject did not go On Treatment remove the Off Treatment Date as well. | This date should be the same or later than the On Study Date. | |
| Missing On Arm Date in Subject Console > Treatment tab. If Off Arm Date is entered then On Arm Date should be entered. | This date should be the same or after the On Study Date. | |
| On Arm Date must be on or after On Study Date | This date should be the same or after the On Study Date. | |
| On Treatment Date must be on or after On Study Date | This date should be the same or after the On Study Date. | |
| Off Treatment Date must be on or after On Treatment Date | This date should be the same or prior to the Off Arm Date, if arm dates are required. |
Follow Up
| Query | Explanation | Resolution |
|---|---|---|
| Missing Off Study date in Subject Console > Follow Up tab. Off Study should be entered if Expired Date is entered. | This date should be the same or after the Follow Up date. | OnCore: Documenting a Subject as Off Study |
| Missing Off Study date in Subject Console > Follow Up tab. Off Study should be entered if the Study is documented as Terminated at the participating site. | The participant status of Off Study when all participating sites are Terminated. | OnCore: Documenting a Subject as Off Study |
| Missing Off Study date in Subject Console > Follow Up tab. Off Study Date should be entered if Off Study Reason is entered. | Verify that the Off Study fields of data and reason are consistently entered. | OnCore: Documenting a Subject as Off Study |
| Missing Off Study Reason in Subject Console > Follow Up tab. Off Study Reason should be entered if Off Study Date is entered. | Verify that the Off Study fields of data and reason are consistently entered. | OnCore: Documenting a Subject as Off Study |
| Followup Start Date must be on or after Off Treatment Date | This date should be the same or after the Off Treatment Date. | OnCore: Documenting a Subject as Off Study |
| Off Study date must be on or after Followup Start Date | This date should be the same or after the Follow Up Date. | OnCore: Documenting a Subject as Off Study |