NCT Number should be entered prior to SMPH Review Request Signoff as it populates to Health Link at that time.

The PC Console > Status > Checklist > CT Reporting checklist should be completed to indicate whether or not the UWCCC is responsible for registering the trial with ClinicalTrials.gov.

If Yes, then PRC is entered in the PC Console > Management > Protocol Staff section.

If Yes, then PC Console > Treatment > Arm > Drug field is entered.

If Yes, then PC Console > Treatment > Modality > Modality field is entered.

OnCore: Adding and Removing Staff From OnCore Protocols

OnCore: Completing the Treatment Tab

Oncology (DT4)

Protocols with PC Console > Main > Protocol Type of (Treatment, Prevention, Supportive Care) should have PC Console > Main > Data Table 4 Report Type of "Interventional"

Protocols with PC Console > Protocol Type of Basic Science should have PC Console > Main > Data Table 4 Report Type of "Ancillary or Correlative"

Protocols with PC Console > Main > Protocol Type of (Biospecimen Repository, Chart Review, Registry/Database, Compassionate Use, Extension) should have PC Console > Main > Data Table 4 Report Type of "Not Applicable."

Protocols with PC Console > Main > Protocol Type of (Screening, Health Services Research) should have PC Console > Main > Data Table 4 Report Type of "Observational" if accrual is applicable.

Protocols with PC Console > Main > Protocol Type of (Screening) should have PC Console > Main > Data Table 4 Report Type of "Not Applicable" if PC > Main > Accrual Information > Accrual Not Applicable is checked.

Protocols with PC Console > Main > Data Table 4 Report Type of "Observational" or "Ancillary or Correlative" should have PC Console > Main > Protocol Type of "Basic Science", "Screening", "Diagnostic", "Other" or "Health Services Research".

Protocols with PC Console > Main > Protocol Type of "Treatment" should not have PC Console > Main > Phase "N/A".

Protocols with Drug should have Data Table 4 Report Type of "Interventional" except when Protocol Type is Compassionate Use or Extension

Protocols with a Device listed in PC Console > Treatment tab should have Data Table 4 Report Type of "Interventional" except when Protocol Type is Compassionate Use or Extension

Data Table 4 Report Type: Interventional is entered for the PC Console > Main > Data Table 4 Report Type field for the following protocol types: Treatment, Supportive Care, Prevention, .

Data Table 4 Report Type: "Observational" is entered for the PC Console > Main > Data Table 4 Report Type field for the following protocol types: Screening, Diagnostic.

Data Table 4 Report Type: "Not Applicable" is entered for the PC Console > Main > Data Table 4 Report Type field for the following protocol type(s): Extension (Rollover), Health Services Research, Basic Science, Compassionate Use, Registry/Database, Biospecimen Repository, Other.

Oncology (DT4)

Missing Data Table 4 Report Type in PC Console > Main tab

Protocols with PC Console > Main > Data Table 4 Report Type of Interventional should not have PC Console > Main > Summary Accrual Only checked Yes.

Protocols with PC Console > Main > Summary Accrual Only checked Yes should not have PC Console > Main > Data Table 4 Report Type of Interventional

Protocols with PC Console > Protocol Type of Basic Science should have PC Console > Main > Data Table 4 Report Type of "Ancillary or Correlative"

Protocols with PC Console > Main > Protocol Type of (Biospecimen Repository, Chart Review, Registry/Database, Compassionate Use, Extension) should have PC Console > Main > Data Table 4 Report Type of "Not Applicable."

Protocols with PC Console > Main > Protocol Type of (Biospecimen Repository, Chart Review, Registry/Database, Compassionate Use, Extension) should have PC Console > Main > Data Table 4 Report Type of "Not Applicable."

Protocols with PC Console > Main > Protocol Type of (Screening, Health Services Research) should have PC Console > Main > Data Table 4 Report Type of "Observational" if accrual is applicable.

Protocols with PC > Main > Accrual Information > Accrual Not Applicable checked "Yes" should have PC Console > Main > Data Table 4 Report Type = "Not Applicable"

Protocols with PC Console > Main > Protocol Type of (Screening) should have PC Console > Main > Data Table 4 Report Type of "Not Applicable" if PC > Main > Accrual Information > Accrual Not Applicable is checked.

Protocols with PC Console > Main &gt Data Table 4 Report Type of "Observational" or "Ancillary or Correlative" should have PC Console > Main > Protocol Type of "Basic Science", "Screening", "Diagnostic", "Other" or "Health Services Research".

OAO studies should have PC Console > Main > Data Table 4 Report Type "Not Applicable" unless PC Console > Main > IIT = Yes

Protocols with a Data Table 4 Type of "Interventional" should not have PC Console > Main > Accrual Not Applicable checked.

Protocols with a Data Table 4 Type of "Interventional" should not have PC Console > Main > Data Monitoring = "N/A"

Protocols with Data Table 4 Report Type of "Interventional" should have a modality entered in PC Console > Treatment tab

Protocols with Drug should have Data Table 4 Report Type of "Interventional" except when Protocol Type is Compassionate Use or Extension

Protocols with a Device listed in PC Console > Treatment tab should have Data Table 4 Report Type of "Interventional" except when Protocol Type is Compassionate Use or Extension

Select "Interventional" for following Protocol Types: Treatment, Supportive Care, and Prevention. In some instances: Diagnostic if it meets the UWCCC Accrual Definition and involves an IND or IDE.

Select "Observational" for Screening and Health Services Research studies if they met the UWCCC Accrual Definition.

Select "Ancillary or Correlative" for Basic Science studies if they meet the UWCCC Accrual definition.

Select "Not Applicable" for Registry, Biospecimen Repository, Compassionate User, Extension (Rollover). For protocols that do not meet the UWCCC Accrual Definition or protocols that are Open for Affiliates Only and are not authored by an UW investigator.

Missing Data Monitoring field in PC Console > Main tab

For protocols with Data Monitoring = "NA" the DSMC Review Frequency in the PC Console > Management tab should be "0"

Oncology:

PC Console > Main > Data Monitoring should be External or N/A for protocols with Industry or National Group principal sponsor.

PC Console > Main > Data Monitoring should be Internal for any study with UWCCC listed as a sponsor.

PC Console > Main > Data Monitoring should be External if UWCCC is not listed as a sponsor.

Protocols that have an Externally Peer Reviewed sponsor as principal and Data Monitoring as External should not list UWCCC in the Sponsor tab

Protocols with a Data Table 4 Type of "Interventional" should not have PC Console > Main > Data Monitoring = "N/A"

Missing Multi-Site Trial in PC Console > Main tab

Missing Pragmatic Trial field in PC Console > Main tab

Missing Summary Accrual Only field in PC Console > Main tab

If this box is checked the 'Exclude Protocol from the Web' checkbox should be checked.

OnCore: DFD - Summary Accrual Info. Only

OnCore: Entering Summary Accrual Information

Missing Protocol Target Accrual in PC Console > Main

Current accrual over PC Console > Main > Protocol Target Accrual

For multi site studies, the PC Console > Main > Accrual Information > RC Total Accrual Goals (Lower and Upper) should be less than the Protocol Target Accrual

The PC Console > Main > RC Total Accrual Goal (Upper) should be greater than or equal to the RC Total Accrual Goal (Lower)

For single institution studies, the PC Console > Main > Protocol Target Accrual should be equal to the RC Upper Accrual Goal

This field needs to be updated as the accrual goal estimation change.

OnCore: Documenting Protocol Accrual Information and Completion Dates

Missing Research Center (RC) Total Accrual Goal (Lower) in PC Console > Main

The PC Console > Main > RC Total Accrual Goal (Lower) should be less than or equal to the RC Total Accrual Goal (Upper)

This field needs to be updated as the accrual goal estimation change.

For multi-site studies, this field should be lower than the Protocol Target Accrual field.

OnCore: Documenting Protocol Accrual Information and Completion Dates

Missing Research Center (RC) Annual Accrual Goal in PC Console > Main

This field needs to be updated as the accrual estimations change.

OnCore: Documenting Protocol Accrual Information and Completion Dates

Missing Affiliate Accrual Goal in PC Console > Main tab

For multi site studies, the PC Console > Main > Accrual Information > RC Total Accrual Goal (Lower) should be less than the Protocol Target Accrual.

This field should be completed for all Open to Affiliates (OAO) studies open to accrual.

OnCore: Documenting Protocol Accrual Information and Completion Dates

Oncology:

Missing DSMC Review Frequency field in PC Console > Management tab

Protocols with External Data Monitoring should have Management > DSMC Review frequency of 12 months.

For protocols with Data Monitoring = "NA" the DSMC Review Frequency in the PC Console > Management tab should be "0"

Missing CRU No. in PC Console > Management tab

If PC Console > Management > CRU No. is entered, CRU Participation should be "Yes".

Missing CRU Approval Date in PC Console > Management tab

If PC Console > Management > CRU Approval Date is entered, CRU Participation should be "Yes".

Missing CRU Category in PC Console > Management tab

If PC Console > Management > CRU Category is entered, CRU Participation should be "Yes"

Oncology:

Missing Program Area in PC Console > Management

Oncology:

Research Groups listed in the PC Console > Management tab > Research Group should also be listed in PC Console > Management tab > Management Group

OnCore: Completing the Management Tab

Oncology:

UW Enrolling Provider/Faculty should not be listed in the PC Console > Staff tab (it should only be listed in the Subject Console > On Study > Staff tab)

Missing Affiliate Coordinator in PC Console > Staff tab.

Open for Affiliates Only protocols should list Affiliate PI in PC Console > Staff tab.

Missing CRU, CRU Staff/Staff Role in PC Console > Staff tab.

PC Console > Staff > Staff Name of "CRU, CRU" should be listed with Role Name "Clinical Research Unit (CRU)".

Clinical Research Unit (CRU) is entered if the PC Console > Management > CRU Participation field is 'Yes'.

Ancillary Services that need access to the protocol and notifications.

Missing PRC, PRC Staff/Staff Role in PC Console > Staff tab.

PC Console > Staff > Staff Name of "PRC, PRC" should be listed with Role Name "Pharmaceutical Research Center".

Protocol with PC Console > Main > Drug Accountability checked 'Yes' should have PRC listed in the PC Console ? Main > Staff tab.

Protocols with PRC listed in PC Console > Staff tab should have Drug listed in PC Console > Treatment tab.

Protocols with PRC listed in PC Console > Staff tab should have Drug Accountability checked 'Yes' in PC Console > Main.

Protocols with IND/IDE > Investigational Drug set to 'Y' should also list PRC in Protocol Staff.

PRC entered if a drug is listed in the PC Console > Treatment > Arm > Drug field and/or if PC Console > Main > Investigational Drug or Drug Accountability is 'Yes'.

Ancillary Services that need access to the protocol and notifications.

Missing CPL, CPL Staff/Staff Role in PC Console > Staff tab.

PC Console > Staff > Staff Name of "CPL, CPL" should be listed with Role Name "Cancer Pharmacology Laboratory".

Ancillary Services that need access to the protocol and notifications.

Missing Biobank, Biobank Staff/Staff Role in PC Console > Staff tab.

Ancillary Services that need access to the protocol and notifications.

Missing Radiology, Radiology Staff/Staff Role in PC Console > Staff tab.

PC Console > Staff > Staff Name of "Radiology, Radiology" should be listed with Role Name "Radiology".

Ancillary Services that need access to the protocol and notifications

Missing Sponsor in PC Console > Sponsor tab

Missing Principal Sponsor in PC Console > Sponsor tab

Multiple principal sponsors

Oncology: 

Protocols that list UWCCC Pilot Award as a sponsor should also have UWCCC listed as a sponsor

Protocols that list UWCCC Pilot Award as a sponsor should have UWCCC marked as principal sponsor

Non-investigator initiated protocols should not list UWCCC as a sponsor

Protocols that list a National Group sponsor should have a National Group sponsor marked as principal

National Group protocols should have the Sponsor Protocol Number match the UWCCC Protocol Number.

UWCCC should be listed in the PC Console > Sponsor tab if UW Investigator holds the IND.

Protocols that have UWCCC listed as principal sponsor should have PC Console > Main > Investigator Initiated Protocol = "Yes"

Externally monitored industry study should not list UWCCC as a sponsor.

If P2C is a sponsor then PC Console > Institution > Participating Networks > should list "Phase II Consortium (P2C)".

A principal sponsor must be marked as Principal Sponsor for the protocol to appear on the Data Table 4 report.

The Financials Console requires a principal sponsor to be checked. 

The sponsors UWCCC IIT Award and PI Funded are financial sponsors that accompany the primary sponsor (UWCCC). They are never a primary sponsor.

If PC Console > Sponsor > Principal Sponsor Type = Industry or Institutional then Protocol Number should start with "UW".

Missing Sponsor Number for Sponsor xxxx in PC Console > Sponsor tab

Principal Sponsor should not have PC Console > Sponsor > Sponsor Number as "Not Applicable", "NA" or "N/A". If there is no Sponsor Number enter the Protocol Number.

Grant/Fund account number field is mandatory for all studies

The grant number for the UWCCC Pilot Award is entered if used for a study; however, it should never be the primary sponsor as it is a funding source. 

Grant/Fund account number field is mandatory for all studies

If PC Console > Main > Investigational Drug or Investigational Device is Yes then PC Console > IND/IDE > ID should be entered.

If PC Console > Main > Investigational Drug or Investigational Device is Yes then PC Console > IND/IDE > Holder Name should be entered.

This field is required for protocols with an IND or IDE.

If PC Console > Main > Investigational Drug or Investigational Device is Yes then PC Console > IND/IDE > Holder Type should be entered.

This field is required for protocols with an IND or IDE.

This field is required for protocols with an IND or IDE.

This field is required if the UW investigator holds the IND or IDE.

This field is required if the UW investigator holds the IND or IDE.

This field is required if the UW investigator holds the IND or IDE.

OnCore: Completing the Treatment Tab

Oncology:

If "Any Site" is selected in PC Console > Treatment > Disease tab then either all disease sites should be selected OR all solid tumor sites should be selected OR all the non solid tumor sites should be selected.

At least one registration step should be entered for all protocols.

At least one am should be entered for all protocols.

Oncoogy: If modality is entered, the PC Console > Main > Details > Data Table 4 Report Type should be Interventional.

Immunotherapy is selected for antibody drugs and vaccines. Other is selected for stem cells and prochymal.

Protocols with IND/IDE > Investigational Drug set to "Y" should have at least one drug listed in PC Console > Treatment tab.

Protocols with PC Console > Main > Drug Accountability checked Yes should have a Drug listed in Treatment > Details tab.

The drug entered here should match the drug listed in the protocol and/or protocol title.

 If drug is entered, PRC should be entered in PC Console > Main > Staff

Oncology: If drug is entered, the PC Console > Main > Details Data Table 4 Report Type field should be Interventional except when the Protocol Type is Compassionate Use or Extension in which case the Data Table 4 Report Type field should be Not Applicable. 

The device entered here should match the device listed in the protocol and/or protocol title.

Oncology: If device is entered, the PC Console > Main > Details Data Table 4 Report Type field should be Interventional except when the Protocol Type is Compassionate Use or Extension in which case the Data Table 4 Report Type field should be Not Applicable. 

Oncology:

If Any Site is entered in PC Console > Disease tab then all applicable sites should be listed as well.

If "Any Site" is selected in PC Console > Treatment > Disease tab then either all disease sites should be selected OR all solid tumor sites should be selected OR all the non solid tumor sites should be selected.

For single institution studies, the PC Console > Main > Protocol Target Accrual should be equal to the RC Upper Accrual Goal.

Oncology:

If "_External Institution(s)" is listed as a Research Group or Management Group in PC Console > Management, then an Affiliate institution should be listed in PC Console > Institution

If UWCCC 1 South Park is listed as a Research Group or a Management Group in PC Console > Management, then UW Health 1 S. Park should be listed in PC Console > Institutions > Study Site.

Missing Affiliate Institution in PC Console > Accrual tab for Affiliate accrual from date to date.

External Institution should be the primary Managing Group for Open for Affiliates Only protocols.

PC Console > Main tab> Multi-Site Trial should be Yes if there are more than one participating institution listed in PC Console > institution tab.