OnCore: Subject Quality Control

Outline of the OnCore protocol related data field quality control, explanation and resolution guidance.

Subject Console sections

Table of data quality control explanation and resolution
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

Table of data quality control explanation and resolution
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 Update subject status to Consent Withdrawn or Not Eligible, as applicable.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

Table of data quality control explanation and resolution
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

Table of data quality control explanation and resolution
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

Table of data quality control explanation and resolution
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.

Table of data quality control explanation and resolution
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

Keywords:

subject participant qc query resolution

Doc ID:

127243

Owned by:

Molly H. in SMPH Research Informatics

Created:

2023-04-12

Updated:

2023-09-26

Sites:

SMPH Research Informatics