FAQ

Frequently Asked Questions

This list will be continuously updated as feedback is received. Please check back periodically for updates.

Billing

Which OnCore statuses will be used for Epic billing?

All OnCore statuses will be used to either drive or stop Epic account review and/or billing activities for CMS required compliant Clinical Trial Policy (CTP) billing.

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How quickly will my enrollment information be available in Epic for billing?

OnCore statuses flow to Epic near-time and will be available for use shortly after your entry.  Per policies at SCCA, UW Medicine, and the Consortium, your entries should be made within 24 hours.

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What if my participant initially screen-fails then returns for screening again at which time the participant becomes eligible for enrollment/treatment. How do I reflect this in the status usage?

OnCore status changes will show in Epic in the Past Updates section and will be available for billing review.  If you are not yet working in OnCore, then you would step through the appropriate Epic statuses (in this example, “Consented”, “Not Eligible”, “Consented”, “Eligible”, “On Study”, “On Treatment”, etc.)

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I’m not going live with OnCore for a while, is something changing for me now?

Yes, the statuses in Epic are being changed right now to align to the OnCore statuses.  You will see more statuses and more specific statuses.

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Which statuses are used for billing during the pre-treatment phase of participation?

Billing offices will begin review and/or perform CTP billing with the status of “Consented” and will work with all statuses up until entry of “On Treatment” for interventional studies and “On Study” for other studies such as observational studies.  Along with these statuses, indications on your orders, visit linking, and appointment notes will be important.

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Which statuses are used for billing during the treatment phase of participation?

Billing offices will review and/or bill beginning with the status of “On Treatment” and through the entry of “Off Treatment” for interventional studies. “On Study” will be used for observational studies without a treatment phase. “On Study” will also be used until “On Treatment” has been entered for all subjects’ post go live who are on interventional studies. During the treatment phase, CTP billing is in place for research-related patient billable items. Along with these statuses, indications on your orders, visit linking, and appointment notes will be important.

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Which statuses are used for billing during the post-treatment phase of participation?

Billing offices will review and/or bill beginning with the status of “Off Treatment” and through the entry of “Off Study”. For Observational Studies and during the go-live period (until on treatment dates have been entered for all subjects on interventional studies) Billing offices will review and/or bill with the status if “On Study” and through the entry of “Off Study”.  “On Follow Up” will also alert the billing offices that there are potential patient or study billable follow up related services. Along with these statuses, indications on your orders, visit linking and appointment notes, will be important.

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Which statuses stop review and billing for research related services?

Billing offices will cease review and/or billing with the statuses of “Not Eligible”, “Withdrawn”, and “Off Study”.

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Which statuses are used for CRBB billing review?

If the subject is in an Active status (Consent waived, Consented, Eligible, On Study, On Treatment, Off Treatment, On Follow up), CRBB uses the enrollment’s “Active start date” in Epic to help determine whether a particular charge is potentially research-related. If the subject is in an Inactive status (Withdrawn, Not Eligible, Off Study, Expired), CRBB uses the enrollment’s “Active start date” and “Active end date” in Epic to help determine whether a particular charge is potentially research-related.

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Billing: CRBB

Which OnCore statuses will be used for Epic billing?

All OnCore statuses will be used to either drive or stop Epic account review and/or billing activities for CMS required compliant Clinical Trial Policy (CTP) billing.

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How quickly will my enrollment information be available in Epic for billing?

OnCore statuses flow to Epic near-time and will be available for use shortly after your entry.  Per policies at SCCA, UW Medicine, and the Consortium, your entries should be made within 24 hours.

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What if my participant initially screen-fails then returns for screening again at which time the participant becomes eligible for enrollment/treatment. How do I reflect this in the status usage?

OnCore status changes will show in Epic in the Past Updates section and will be available for billing review.  If you are not yet working in OnCore, then you would step through the appropriate Epic statuses (in this example, “Consented”, “Not Eligible”, “Consented”, “Eligible”, “On Study”, “On Treatment”, etc.)

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I’m not going live with OnCore for a while, is something changing for me now?

Yes, the statuses in Epic are being changed right now to align to the OnCore statuses.  You will see more statuses and more specific statuses.

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Which statuses are used for CRBB billing review?

If the subject is in an Active status (Consent waived, Consented, Eligible, On Study, On Treatment, Off Treatment, On Follow up), CRBB uses the enrollment’s “Active start date” in Epic to help determine whether a particular charge is potentially research-related. If the subject is in an Inactive status (Withdrawn, Not Eligible, Off Study, Expired), CRBB uses the enrollment’s “Active start date” and “Active end date” in Epic to help determine whether a particular charge is potentially research-related.

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Billing: SCCA

Which OnCore statuses will be used for Epic billing?

All OnCore statuses will be used to either drive or stop Epic account review and/or billing activities for CMS required compliant Clinical Trial Policy (CTP) billing.

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How quickly will my enrollment information be available in Epic for billing?

OnCore statuses flow to Epic near-time and will be available for use shortly after your entry.  Per policies at SCCA, UW Medicine, and the Consortium, your entries should be made within 24 hours.

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What if my participant initially screen-fails then returns for screening again at which time the participant becomes eligible for enrollment/treatment. How do I reflect this in the status usage?

OnCore status changes will show in Epic in the Past Updates section and will be available for billing review.  If you are not yet working in OnCore, then you would step through the appropriate Epic statuses (in this example, “Consented”, “Not Eligible”, “Consented”, “Eligible”, “On Study”, “On Treatment”, etc.)

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I’m not going live with OnCore for a while, is something changing for me now?

Yes, the statuses in Epic are being changed right now to align to the OnCore statuses.  You will see more statuses and more specific statuses.

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Which statuses are used for billing during the pre-treatment phase of participation?

Billing offices will begin review and/or perform CTP billing with the status of “Consented” and will work with all statuses up until entry of “On Treatment” for interventional studies and “On Study” for other studies such as observational studies.  Along with these statuses, indications on your orders, visit linking, and appointment notes will be important.

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Which statuses are used for billing during the treatment phase of participation?

Billing offices will review and/or bill beginning with the status of “On Treatment” and through the entry of “Off Treatment” for interventional studies. “On Study” will be used for observational studies without a treatment phase. “On Study” will also be used until “On Treatment” has been entered for all subjects’ post go live who are on interventional studies. During the treatment phase, CTP billing is in place for research-related patient billable items. Along with these statuses, indications on your orders, visit linking, and appointment notes will be important.

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Which statuses are used for billing during the post-treatment phase of participation?

Billing offices will review and/or bill beginning with the status of “Off Treatment” and through the entry of “Off Study”. For Observational Studies and during the go-live period (until on treatment dates have been entered for all subjects on interventional studies) Billing offices will review and/or bill with the status if “On Study” and through the entry of “Off Study”.  “On Follow Up” will also alert the billing offices that there are potential patient or study billable follow up related services. Along with these statuses, indications on your orders, visit linking and appointment notes, will be important.

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Which statuses stop review and billing for research related services?

Billing offices will cease review and/or billing with the statuses of “Not Eligible”, “Withdrawn”, and “Off Study”.

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Billing: UWP

Which OnCore statuses will be used for Epic billing?

All OnCore statuses will be used to either drive or stop Epic account review and/or billing activities for CMS required compliant Clinical Trial Policy (CTP) billing.

Permalink

How quickly will my enrollment information be available in Epic for billing?

OnCore statuses flow to Epic near-time and will be available for use shortly after your entry.  Per policies at SCCA, UW Medicine, and the Consortium, your entries should be made within 24 hours.

Permalink

What if my participant initially screen-fails then returns for screening again at which time the participant becomes eligible for enrollment/treatment. How do I reflect this in the status usage?

OnCore status changes will show in Epic in the Past Updates section and will be available for billing review.  If you are not yet working in OnCore, then you would step through the appropriate Epic statuses (in this example, “Consented”, “Not Eligible”, “Consented”, “Eligible”, “On Study”, “On Treatment”, etc.)

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I’m not going live with OnCore for a while, is something changing for me now?

Yes, the statuses in Epic are being changed right now to align to the OnCore statuses.  You will see more statuses and more specific statuses.

Permalink

Which statuses are used for billing during the pre-treatment phase of participation?

Billing offices will begin review and/or perform CTP billing with the status of “Consented” and will work with all statuses up until entry of “On Treatment” for interventional studies and “On Study” for other studies such as observational studies.  Along with these statuses, indications on your orders, visit linking, and appointment notes will be important.

Permalink

Which statuses are used for billing during the treatment phase of participation?

Billing offices will review and/or bill beginning with the status of “On Treatment” and through the entry of “Off Treatment” for interventional studies. “On Study” will be used for observational studies without a treatment phase. “On Study” will also be used until “On Treatment” has been entered for all subjects’ post go live who are on interventional studies. During the treatment phase, CTP billing is in place for research-related patient billable items. Along with these statuses, indications on your orders, visit linking, and appointment notes will be important.

Permalink

Which statuses are used for billing during the post-treatment phase of participation?

Billing offices will review and/or bill beginning with the status of “Off Treatment” and through the entry of “Off Study”. For Observational Studies and during the go-live period (until on treatment dates have been entered for all subjects on interventional studies) Billing offices will review and/or bill with the status if “On Study” and through the entry of “Off Study”.  “On Follow Up” will also alert the billing offices that there are potential patient or study billable follow up related services. Along with these statuses, indications on your orders, visit linking and appointment notes, will be important.

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Which statuses stop review and billing for research related services?

Billing offices will cease review and/or billing with the statuses of “Not Eligible”, “Withdrawn”, and “Off Study”.

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Data Validation

What is the definition of consented date? Do you want the first consented date regardless of consent type?   

This is the date for the initial consent. For purposes of go-live, please review and provide the earliest consent date in scenarios where the consent date is blank. 

If the consent date is already populated from PATS, no modification is needed until after go-live when you will need to go in and enter the multiple consents and dates. 

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Do we need to go into OnCore and enter all screen fails after the go-live? 

Screen fails  that occur after 7/16/2018 (your go-live date for OnCore)  must be entered into OnCore.  

Screen fails  that occurred prior to 7/16/2018 are optional for OnCore entry but may be required by Sponsors and/or regulatory agencies.  

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If we have screen fail information now, how do we indicate it on the spreadsheet?

If you have screen fail information available, please add a column called “screen_fail_date”  and indicate date the subject failed screening.

Also,  please fill in a “consent_date” for the subject if that field is blank. If “consent_date” is not known, please indicate “Not Known” and we will populate the active start date from Epic if available.

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What is the OnCore definition/functionality of On Study?

On Study is defined as the date the study subject has been registered to the study after having completed the eligibility step and has received a subject ID from the sponsor. The On Study date is the required date in OnCore for accrual credit. It is not related to billing. In the CTMS workflow, subjects will be marked as Billing Active in Epic as soon as they have consented to the study and have a consented date recorded in OnCore.  

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How do you differentiate between On Follow Up Date and Off Treatment Date?

On Follow Up date  is the first  actual protocol-defined follow up visit date  and  will be on or after the  Off  Treatment  date. For example, depending on your protocol, the EOT visit may be the last On Study date and the first On Follow Up date.

The  Off  Treatment  date is the date the study subject stops receiving the study intervention or when the study treatment or procedure the study is tracking ends.

 

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There is  a significant difference  between  research  activity and billing activity – can you clarify On Follow Up & Off Study statuses please? 

On Follow Up: The date the study subject is enrolled in the follow-up phase of the study regardless of whether study specific billing is  occurring  or not.   

Off Study: The date the study subject is completely off the study at study completion. No further activity occurs, including billing activity.

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What are some examples for how to determine On Follow Up dates? 

To identify what constitutes the start of the follow-up phase, we suggest deferring to what each protocol defines as the start of the follow-up phase. It might be first visit post last dose, 28-day follow-up etc., depending on the specific protocol. For the existing studies if you would like to adopt a simplified approach of applying the date related to the first visit post last dose that may be acceptable.

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What about Observational Studies? Do the statuses of On Follow Up, On Treatment and Off Treatment apply to these studies?

On Treatment, On Follow Up and Off Treatment don’t necessarily apply to all studies. For example, subjects on observation studies may directly progress from On Study to Off Study without being marked as On Treatment, Off Treatment or Follow Up.

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Survival is  an endpoint  for the vast majority of our studies – do you want death date as Off Study date? 

The CTMS Program Office will update all deceased patients as Off Study using the deceased date as the Off Study date.

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Do we need to enter subjects enrolled at external sites?

All subjects regardless of site of enrollment need to go in to the CTMS. If we have site of enrollment from PATS, we will attach those subjects to their respective site. If we do NOT have site information for a subject, it will be up to the study team to accurately match the subject to the site. 

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General CTMS

What are the Targets and Timing for Implementation of the CTMS?

The implementation strategy is divided into three targets:

  • Target #1: Subjects & Protocols – UW/FH Cancer Consortium Oncology & FH Non-Oncology
  • Target #2: Subjects & Protocols – UW Non-Oncology Assessment
  • Target #3: Study Calendars & Financial Management

Timing for each Target varies. Currently:

  • Target #1 will go live summer of 2018. Please see Onboarding Updates for specific dates.
  • Target #2 is scheduled to go live in 2019, specific dates not yet set.
  • Target #3 is not yet scheduled.

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When will my study team be live in the CTMS?

UW/FH Cancer Consortium Oncology studies and FH Non-Oncology study teams will go live in 2018 as part of Group 1 (July 16, 2018) or Group 2 (September 17, 2018). Non-oncology studies will go live in 2019, exact dates yet to be determined. To find out if your team is in Group 1 or Group 2, please see our earlier announcement.

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What if my team manages oncology and non-oncology studies? Will my oncology studies go into the CTMS at a different time than my non oncology studies?

If your study team has oncology and non-oncology studies, each set will go-live at different times according to the CTMS Program targets:

  • Target 1 includes UW/FH Cancer Consortium Oncology studies and FH Non Oncology studies.
  • Target 2 includes UW Non Oncology studies.

The studies that fall within Target 1 will go live in 2018 as part of Group 1 (July 16, 2018) or Group 2 (September 17, 2018). For a list of study teams that are part of Group 1 and Group 2 please see our earlier announcement.

Any non-oncology studies that fall within Target 2 will go-live in 2019 / 2020.

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Currently, subject demographics are sent from Epic to PATS. Will this data now be sent to CTMS?

Yes. OnCore is set up to receive demographics information from Epic, provided that participants have a patient record in our Epic system.

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Will I still submit documents to the Fred Hutch Clinical Research Support office (CRS)?

CRS will continue uploading documents into Clinical FYI for an interim period of time.

After all T1 study teams  are live in OnCore and stable (by Q1 of CY 2019), OnCore will replace Clinical FYI as the repository for current protocol documents. At that time study teams will need to upload current versions of documents into OnCore. Study Teams do NOT need to upload documents in OnCore upon go-live.

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How will the clinic access my protocol documents?

Clinics will continue to use Clinical FYI for protocol documents until after all Target 1 groups (UW/FH Cancer Consortium and FH Non-Oncology) are live.

Specific information on when clinics will need to access documents directly in OnCore will be made available in May/June 2018.

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Will external performance sites have access to our CTMS for multi-site trials when we are the coordinating site?

We are assessing the appropriate workflow for this scenario and will have more information later in summer of 2018.

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Will I now need to start reporting enrollment data for studies that I have not reported enrollment for in the past, such as chart reviews and specimen banking?

For chart reviews, reporting enrollment data is optional.

For specimen banking, enrollment data may be required if you are required to obtain an Epic Research Study Account number for the specimen collection.  If you are obtaining patient consent, you will need to enter enrollment information. In other cases it may be optional. Specific guidance on when enrollment data is required will be provided as part of CTMS training.

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What type of studies are going to be in the CTMS? Will my minimal risk studies be in the CTMS? Will non-oncology human subjects research conducted at Fred Hutch be included in the CTMS?

For FH/UW Consortium and FH non-oncology, all human subjects research will be tracked in the CTMS, including minimal risk studies. The amount of information entered into the CTMS will vary depending on the type of study.

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Will closed studies be migrated to the CTMS?

Studies that may be closed now, but were open to accrual as of 10/1/2012 will be migrated into the CTMS to support NCI reporting.

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What if our studies have not historically been submitted to CRS? How will our studies be migrated into the CTMS?

The project team will work with you to obtain your data. In some cases, we are scanning files from the IRB and abstracting the information required for the CTMS. Please contact the CTMS Program Office regarding questions.

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Will faculty be able to view all of our trials in the CTMS? Will they be able to view trials across other groups?

Yes, faculty and staff who require access to study information and documentation will have permission to view basic protocol information and to download study documents across groups.

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Target 1

When will my study team be live in the CTMS?

UW/FH Cancer Consortium Oncology studies and FH Non-Oncology study teams will go live in 2018 as part of Group 1 (July 16, 2018) or Group 2 (September 17, 2018). Non-oncology studies will go live in 2019, exact dates yet to be determined. To find out if your team is in Group 1 or Group 2, please see our earlier announcement.

Permalink

What if my team manages oncology and non-oncology studies? Will my oncology studies go into the CTMS at a different time than my non oncology studies?

If your study team has oncology and non-oncology studies, each set will go-live at different times according to the CTMS Program targets:

  • Target 1 includes UW/FH Cancer Consortium Oncology studies and FH Non Oncology studies.
  • Target 2 includes UW Non Oncology studies.

The studies that fall within Target 1 will go live in 2018 as part of Group 1 (July 16, 2018) or Group 2 (September 17, 2018). For a list of study teams that are part of Group 1 and Group 2 please see our earlier announcement.

Any non-oncology studies that fall within Target 2 will go-live in 2019 / 2020.

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What is the definition of consented date? Do you want the first consented date regardless of consent type?   

This is the date for the initial consent. For purposes of go-live, please review and provide the earliest consent date in scenarios where the consent date is blank. 

If the consent date is already populated from PATS, no modification is needed until after go-live when you will need to go in and enter the multiple consents and dates. 

Permalink

Do we need to go into OnCore and enter all screen fails after the go-live? 

Screen fails  that occur after 7/16/2018 (your go-live date for OnCore)  must be entered into OnCore.  

Screen fails  that occurred prior to 7/16/2018 are optional for OnCore entry but may be required by Sponsors and/or regulatory agencies.  

Permalink

If we have screen fail information now, how do we indicate it on the spreadsheet?

If you have screen fail information available, please add a column called “screen_fail_date”  and indicate date the subject failed screening.

Also,  please fill in a “consent_date” for the subject if that field is blank. If “consent_date” is not known, please indicate “Not Known” and we will populate the active start date from Epic if available.

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What is the OnCore definition/functionality of On Study?

On Study is defined as the date the study subject has been registered to the study after having completed the eligibility step and has received a subject ID from the sponsor. The On Study date is the required date in OnCore for accrual credit. It is not related to billing. In the CTMS workflow, subjects will be marked as Billing Active in Epic as soon as they have consented to the study and have a consented date recorded in OnCore.  

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How do you differentiate between On Follow Up Date and Off Treatment Date?

On Follow Up date  is the first  actual protocol-defined follow up visit date  and  will be on or after the  Off  Treatment  date. For example, depending on your protocol, the EOT visit may be the last On Study date and the first On Follow Up date.

The  Off  Treatment  date is the date the study subject stops receiving the study intervention or when the study treatment or procedure the study is tracking ends.

 

Permalink

There is  a significant difference  between  research  activity and billing activity – can you clarify On Follow Up & Off Study statuses please? 

On Follow Up: The date the study subject is enrolled in the follow-up phase of the study regardless of whether study specific billing is  occurring  or not.   

Off Study: The date the study subject is completely off the study at study completion. No further activity occurs, including billing activity.

Permalink

What are some examples for how to determine On Follow Up dates? 

To identify what constitutes the start of the follow-up phase, we suggest deferring to what each protocol defines as the start of the follow-up phase. It might be first visit post last dose, 28-day follow-up etc., depending on the specific protocol. For the existing studies if you would like to adopt a simplified approach of applying the date related to the first visit post last dose that may be acceptable.

Permalink

What about Observational Studies? Do the statuses of On Follow Up, On Treatment and Off Treatment apply to these studies?

On Treatment, On Follow Up and Off Treatment don’t necessarily apply to all studies. For example, subjects on observation studies may directly progress from On Study to Off Study without being marked as On Treatment, Off Treatment or Follow Up.

Permalink

Survival is  an endpoint  for the vast majority of our studies – do you want death date as Off Study date? 

The CTMS Program Office will update all deceased patients as Off Study using the deceased date as the Off Study date.

Permalink

Do we need to enter subjects enrolled at external sites?

All subjects regardless of site of enrollment need to go in to the CTMS. If we have site of enrollment from PATS, we will attach those subjects to their respective site. If we do NOT have site information for a subject, it will be up to the study team to accurately match the subject to the site. 

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Target 1: T1G1

What is the definition of consented date? Do you want the first consented date regardless of consent type?   

This is the date for the initial consent. For purposes of go-live, please review and provide the earliest consent date in scenarios where the consent date is blank. 

If the consent date is already populated from PATS, no modification is needed until after go-live when you will need to go in and enter the multiple consents and dates. 

Permalink

Do we need to go into OnCore and enter all screen fails after the go-live? 

Screen fails  that occur after 7/16/2018 (your go-live date for OnCore)  must be entered into OnCore.  

Screen fails  that occurred prior to 7/16/2018 are optional for OnCore entry but may be required by Sponsors and/or regulatory agencies.  

Permalink

If we have screen fail information now, how do we indicate it on the spreadsheet?

If you have screen fail information available, please add a column called “screen_fail_date”  and indicate date the subject failed screening.

Also,  please fill in a “consent_date” for the subject if that field is blank. If “consent_date” is not known, please indicate “Not Known” and we will populate the active start date from Epic if available.

Permalink

What is the OnCore definition/functionality of On Study?

On Study is defined as the date the study subject has been registered to the study after having completed the eligibility step and has received a subject ID from the sponsor. The On Study date is the required date in OnCore for accrual credit. It is not related to billing. In the CTMS workflow, subjects will be marked as Billing Active in Epic as soon as they have consented to the study and have a consented date recorded in OnCore.  

Permalink

How do you differentiate between On Follow Up Date and Off Treatment Date?

On Follow Up date  is the first  actual protocol-defined follow up visit date  and  will be on or after the  Off  Treatment  date. For example, depending on your protocol, the EOT visit may be the last On Study date and the first On Follow Up date.

The  Off  Treatment  date is the date the study subject stops receiving the study intervention or when the study treatment or procedure the study is tracking ends.

 

Permalink

There is  a significant difference  between  research  activity and billing activity – can you clarify On Follow Up & Off Study statuses please? 

On Follow Up: The date the study subject is enrolled in the follow-up phase of the study regardless of whether study specific billing is  occurring  or not.   

Off Study: The date the study subject is completely off the study at study completion. No further activity occurs, including billing activity.

Permalink

What are some examples for how to determine On Follow Up dates? 

To identify what constitutes the start of the follow-up phase, we suggest deferring to what each protocol defines as the start of the follow-up phase. It might be first visit post last dose, 28-day follow-up etc., depending on the specific protocol. For the existing studies if you would like to adopt a simplified approach of applying the date related to the first visit post last dose that may be acceptable.

Permalink

What about Observational Studies? Do the statuses of On Follow Up, On Treatment and Off Treatment apply to these studies?

On Treatment, On Follow Up and Off Treatment don’t necessarily apply to all studies. For example, subjects on observation studies may directly progress from On Study to Off Study without being marked as On Treatment, Off Treatment or Follow Up.

Permalink

Survival is  an endpoint  for the vast majority of our studies – do you want death date as Off Study date? 

The CTMS Program Office will update all deceased patients as Off Study using the deceased date as the Off Study date.

Permalink

Do we need to enter subjects enrolled at external sites?

All subjects regardless of site of enrollment need to go in to the CTMS. If we have site of enrollment from PATS, we will attach those subjects to their respective site. If we do NOT have site information for a subject, it will be up to the study team to accurately match the subject to the site. 

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Target 2

What if my team manages oncology and non-oncology studies? Will my oncology studies go into the CTMS at a different time than my non oncology studies?

If your study team has oncology and non-oncology studies, each set will go-live at different times according to the CTMS Program targets:

  • Target 1 includes UW/FH Cancer Consortium Oncology studies and FH Non Oncology studies.
  • Target 2 includes UW Non Oncology studies.

The studies that fall within Target 1 will go live in 2018 as part of Group 1 (July 16, 2018) or Group 2 (September 17, 2018). For a list of study teams that are part of Group 1 and Group 2 please see our earlier announcement.

Any non-oncology studies that fall within Target 2 will go-live in 2019 / 2020.

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