Q

What if my patient is coming to UCSF for the first time and does not have a UCSF Medical Record Number (MRN)?

A

Q

Is the subject enrollment requirement retroactive?

A

In order for UCSF to be audit-ready, all subjects need to be enrolled on all open studies. Visits that occurred before May 7, 2018 do not need to be tracked. OCTA will provide resources for the addition of this data if departments would like. We understand this is likely to raise further questions and are happy to discuss with department administrators if they want. Please email us with any concerns. 

Please refer to the OnCore Data Entry Requirements for Study Teams table for further detail.

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Q

Is the requirement for studies closed to accrual or to studies that are completed?

A

This applies to studies that are closed to accrual.  Studies that are closed to accrual may still have accrued patients who are planned to have visits in the future.

Q

Why do we need to track study visits and study subjects in OnCore?

A

Maintaining accurate records of subjects enrolled in trials at UCSF and tracked visits not only supports compliant clinical research billing, but it supports accurate records at UCSF. UCSF’s Clinical Trials Management System of record is OnCore.

Q

Who needs to be enrolled to a study in OnCore?

A

All patients who are associated with a clinical trial that is billed through APeX and have visits after May 7th, 2018 must be enrolled in OnCore. [Please note: Cancer Center requirements for Subject Enrollment in OnCore may be stricter.]

Q

If the mandate is that anything billable via APeX needs to be included, what do you mean by “billing?”

A

If a study subject, as part of a clinical research study at UCSF, is expected to incur charges at UCSF for any events or procedures (either related to the study or SOC), that subject needs to be enrolled in OnCore to the study.

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Q

How do we track subjects that are screened, but ultimately don’t qualify to enroll in the study?

A

Subjects can be consented to have a screening visit. However, if they fail the screening, please leave their current Subject Status as-is. Do NOT progress them any further in  OnCore.

Q

The subject tracking requirement begins on May 7, 2018.  Do I need to enter subject visits that happened prior to May 7, 2018?

A

No, you only need to enter visits after May 7, 2018.

Q

Is the tracking requirement only applicable to therapeutic studies?

A

No - it is applicable to any studies where any charges (for research, standard of care, or any combination thereof) could be dropped in APeX.

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Q

How soon does patient visit information need to be entered into OnCore?

A

Within 24 hours of the visit.

Q

Does the tracking requirement apply for patients on a trial if they are seen at a different site?

A

It only applies to enrolled UCSF study participants who will or might generate charges in APeX. [Please note that for Cancer-related trials, study teams may need to track non-UCSF patients as well.]

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Q

What if 90% of my patients have completed the study before the tracking requirement goes into effect?  Do I need to enter all protocol subjects or just those that will continue to have visits?

A

You only need to enter patients that will have future visits.

Q

The subject tracking requirement begins on May 7, 2018.  My study is closed at UCSF, but is still open at other sites.  Do I still need to track patients?

A

No, you don’t need to track patients that are seen at a different site. [Please note that for Cancer-related trials, study teams may need to track non-UCSF patients as well.]

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Q

Do I need to enter subject visit information if the final patient has completed the study before May 7, 2018 but the study is still open for administrative reasons (invoicing, data analysis, etc.)?

A

No, you only need to track visits for studies that have ongoing patient activity.

Q

What happens if we don’t track visits in OnCore?  Who ‘polices’ this?

A

The OCTA will monitor compliance. If study teams are chronically noncompliant, your study will be shut down and you will not have access to APeX.  The study can be reopened if the PI agrees to bring the study team into compliance.

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Q

Does the tracking requirement apply to a study that only has two biopsies (one prior to study enrollment and one at disease progression) at UCSF and the other visits may take place at off-site locations?

A

Yes, this still needs to be tracked.  The visits that occur off-site can be marked as missed visits.

Q

What if the protocol has a range of possible dates for the visits (ex. the visit window is plus or minus one day)?

A

The protocol calendar can be customized to reflect the appropriate visit window.

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Q

What happens if a screening visit takes place on multiple dates (e.g. clinic visit happens on a different date than the imaging visit)?

A

You can enter a single visit date as long as the dates are within the visit tolerance window listed in the protocol.  In general, calendars expect visit dates to be treatment dates. It’s also possible to list the date of each procedure that occurred during the visit.

Q

My study has imaging visits, but it is primarily a chemotherapy study.  Who should track the visits – the team responsible for the radiology visits or the chemo visits?

A

This should be decided by the study team.  However, please note the data should not be entered twice.

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Q

In my role, I help with protocol development.  How will I know if subject tracking is required for future studies?  Is it only for clinical trials?

A

This requirement pertains to all clinical research studies that take place at UCSF, including within the Medical Center.  Subject tracking is required for studies that involve putting anything in or taking something out of a human.

Q

What is the difference between “clinical research” vs “clinical trials” as we refer to our work? What’s the correct terminology to use?

A

Clinical research is any research involving human subjects. A clinical trial is a type of clinical research study; it is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective.  For the purposes of this mandate, we are referring to any clinical research study that is conducted on Medical Center space and has procedures/tests that are documented in APeX.

Q

If the mandate is that anything billable in APeX needs to be included, what do you mean by “billing?”

A

If a study subject, as part of a clinical research study at UCSF, is expected to incur charges at UCSF for any events or procedures (either related to the study or SOC), that subject needs to be enrolled in OnCore to the study.

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Q

What does “PC” in “PC Console” stand for?

A

PC = Protocol Coordinator

Q

What does “CRA” in “CRA Console” stand for?

A

CRA = Clinical Research Associate

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Q

Is “enrollment” the same as “registration?”

A

Enrollment is the entire process from start to finish (Consent, Eligibility, On Study, On Treatment). Registration is one piece of the enrollment process and involves only recording demographics.

Q

How are you defining a closed study?  Do we have to enter data for closed studies?

A

For this purpose, a closed study is one that has no further patient activity on or after May 7, 2018.  You only have to enter data for active studies.  The OCTA team will be in contact in the future to enter data for closed studies.

Q

What about studies not falling into the category of “clinical trials?”

A

Studies where subjects will incur NO charges at UCSF do not require subject enrollment. [Please note: HDFCCC studies may still require enrollment in OnCore.]

Q

What will a department like Hematology-Oncology do if they are linked to Cancer Center but not currently using OnCore?

A

Any study teams not currently using OnCore will need to take OnCore training, request OnCore accounts, and enroll and manage their subjects and complete visit tracking in OnCore from May 7, 2018, forward.

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Q

What if the study patient is not a UC patient?

A

Any study patient who is seen or treated at UCSF is a UCSF patient and needs a UCSF MRN, regardless of whether he/she comes to us from or is typically treated by another provider such as Kaiser. If your subject does not yet have a UCSF MRN, contact Hospital Admissions at 415-353-1488.

Q

What about studies that are purely observational?

A

If there are procedures occurring within Medical Center space, then yes, the participants need to be registered in APeX and tracked in OnCore. If participants are not visiting UCSF and no charges (research or Standard of Care) will be incurred, then subject enrollment is not required. [Please note: HDFCCC studies may still require enrollment in OnCore.]

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Q

What about a study that only involves chart review?

A

Chart review studies do not have to be tracked in OnCore because there are no procedures that could result in a bill. [Please note: HDFCCC studies may still require enrollment in OnCore.]

Q

What about a research study where the only procedure is non-billable specimen collection (i.e. surgical discard specimen collection)?

A

These subjects do not need to be tracked in OnCore. [Please note: HDFCCC studies may still require enrollment in OnCore.]

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Q

What if my study has procedures that occur within the Medical Center, but there isn’t any standard of care (SOC) billing?

A

The subject visits still need to be tracked in OnCore because the research sponsor will be billed for those procedures.  The institution needs to document that these procedures were billed according to the coverage analysis for the study.

Q

Does this apply to patients in a research study where everything is billed as standard of care and we were told the study didn’t need Coverage Analysis?

A

Yes, the patients are still enrolled in a research study and the University needs to be able to show that charges were routed appropriately.

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Q

Who is the contact person if we think there is an issue with an existing Coverage Analysis? 

A

Please contact [email protected] and the OCTA team will review. The Coverage Analysis team makes billing determinations based on Medicare guidelines. 

Q

What pieces of information need to be in OnCore?

A

OnCore houses the study calendar and coverage analysis as well as basic information on the study.  These are entered by the Office of Clinical Trials Activation. 

The study team must enroll all newly consented study subjects in OnCore within 24 hours of consenting.  Study teams must also track all study visits in OnCore and ensure that all individual subject calendars are kept accurate and up to date.

Q

What types of information will be pushed from OnCore to APeX?

A

• Basic protocol information to initiate the research (RSH) study build in APeX
• The billing grid/calendar for the study with billing designations for all expected charges
• Enrolled study subjects who have been given an active consent date
• Subsequent statuses for those enrolled and consented subjects

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Q

What happens to the consent forms uploaded or entered in OnCore – will they get sent to ApeX?

A

No, consent forms do not get sent from OnCore to APeX.

Q

How can we perform mass uploads for retrospective data?

A

Subjects need to be entered on a one-by-one basis.  The OCTA will be supporting study teams in the uploading of this data. Contact [email protected] with questions.

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Q

What if a subject has no MRN? Can the field be blank?

A

No; a subject must have a MRN when being enrolled in OnCore.  This allows APeX to know which patients are associated to a clinical trial when the subject information is sent over from OnCore. Patients must have a UCSF MRN prior to Subject Enrollment in OnCore. If your subject does not yet have an MRN, contact Hospital Admissions at 415-353-1488.

Q

Does data from eCRF automatically move into OnCore?

A

For investigator-initiated studies who use OnCore EDC, the eCRFs will show once subjects are enrolled and have their first visit.  So by default, if study teams are using OnCore EDC, you already have enrolled subjects in OnCore.

For sponsored trials that capture data using sponsor-based data capture systems, there is no connection to OnCore.

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Q

Will patient data need to be entered into OnCore manually, or is it pushed from APeX?

A

OnCore utilizes a demographics interface with APeX which allows for patient data in APeX to be transferred to OnCore when enrolling a subject to a study in OnCore.  When the MRN is entered in the Find Fields “Subject MRN” field during New Subject Registration, APeX is queried and matching results are pulled in to OnCore.

Q

Do we need to enter histology or disease-specific information when we register a patient?

A

This information is not required for SOM studies, but is required for HDFCCC studies.

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Q

Do we have to fill in a date for each of the procedures that occurred during a visit?

A

This is not necessary if the visit occurred as planned and all of the procedures happened on the same day.  Only enter a date if the date of a procedure is different than the Visit Date.

Q

What happens if there are multiple unscheduled visits because a patient needs to be evaluated for adverse events?

A

You can create additional visits on the patient’s calendar.  These unscheduled visits will not be linked to anything in APeX since they are not listed on the original calendar.

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Q

My protocol has a single visit which takes place during an inpatient admission.  How will I enter data for multiple visits into OnCore?

A

Your protocol calendar will have two visits you need to enter dates for: one triggered by Consent Signed date (“Screening Visit”), and one triggered by On Study or On Treatment (“Study Visit”).

Q

If we update a patient's address in OnCore, will APeX automatically be updated?

A

No, APeX will not be automatically updated.  Demographic information, including addresses, should be updated in APeX.  The demographics data (including address) in APeX will update OnCore on a nightly basis.

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Q

If we change a planned visit date in OnCore, will we be able to see the original planned date in APeX?

A

No, you will see the same date that is listed in OnCore.  The original date is removed from the system once a change is made.

Q

We typically consent patients and register them for visits within APeX.  Should this process happen in parallel within OnCore or is the information transferred to OnCore?

A

You will need to search for the patient’s MRN in OnCore and register the patient to the study.  This will transfer the patient’s study calendar/billing grid to APeX.

Q

How long does it typically take to register a patient?

A

It takes approximately 3-5 minutes.

Q

Where do the procedures in the subject calendar come from?

A

The procedures are pulled from the coverage analysis billing grid.

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Q

My research study has multiple Clinical Research Coordinators.  Can all of the CRCs get access to OnCore to track subject visits?

A

Yes, all of the CRCs can have access to the study in OnCore.  Please indicate the names of all of the CRCs who will need access during the protocol intake process.

Q

How far in advance do we need to request OnCore access prior to the start of a study?

A

If you need an OnCore account, be sure you have taken the appropriate training submitted the Account Request Survey at least 1-2 business days prior to your anticipated need to enroll and manage subjects in OnCore.

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Q

Do I see every study here at UCSF and need to filter to my own studies?

A

No; you will only see the protocols to which you are added.

Q

What if a study is run on two locations, e.g.: participant is screened for enrollment at Parnassus research lab (and that includes some procedures) but run at Mission Bay hospital for study visits?

A

The process for subject enrollment and subject visit tracking is the same; the study visit calendar should automatically reflect the correct location(s) for the study treatment(s).

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Q

What if you don’t want to automatically forward all future visit dates in the event of one missed/rescheduled visit?

A

There is an option to advance all future visits by setting the “Reset Calendar?” drop down menu option to “All Visits”, but this is not required.  Leaving the “Reset Calendar?” option defaulted to “No” will leave future calendar dates unchanged.

Q

What do we do when a protocol defined study visit contains procedures that span multiple days?

A

Use of protocol defined visit dates and tolerances windows will allow procedures on either side of this date as specified in the protocol. In general, visit dates during treatment periods are expected to be date of drug dosing. Procedures occurring on a different date can be specified on the Subject Visit Update page. Only enter a date if the date of a procedure is different than the Visit Date. If your study calendar doesn’t show visit tolerances as expected, please contact the OnCore team.

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Q

What is the purpose of the Eligibility page and how does it work into subject enrollment workflow?

A

The Eligibility tab is for tracking eligibility determination by the Investigator for patients with signed Informed Consent forms. Prescreening activities are not tracked in OnCore.

Q

What happens if a participant is enrolled in multiple studies?

A

This will be apparent in OnCore; the CRC will see the other protocol number(s) on the Subject’s Summary Page, but will only have a link to access the protocols he or she is assigned to.

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Q

How should we register a patient who withdraws consent after they’ve enrolled in a study?

A

This should be recorded as patient “off-study.”

Q

How do you document an unscheduled visit in OnCore?

A

Go to the CRA console and open up the subject calendar.  There is a tab for additional visits.  You can add an unscheduled visit by selecting this button.  This visit will not be connected to the protocol billing grid.

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Q

What if one of the patients on my study transferred from another site?

A

Register the patient in OnCore and the visits that occurred at a different site should be marked as “missed.”  Alternatively, there is an option to transfer a patient between sites if both sites use OnCore.

Q

Will the anticipated/planned dates for future visits be auto-populated after I’ve entered the date of the Screen/Day 1 visit?

A

Yes, the planned dates of future visits will auto-populate.

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Q

How does OnCore know which arm my patient is enrolled in?

A

You select the protocol arm when you register the patient.  Procedures (or visits) that are not applicable to a particular arm will be grayed out on the study calendar.

Q

How do we assign an off-study status to patients that have screen failed or withdrawn?  OnCore has the option of listing screen fail or withdrawn as the correct status, and this is our current practice.

A

A patient can and should be placed On Study after the screening visit. In OnCore, after the consent, a patient can have their screening visit and then, depending on the result, be placed On Study. This allows for a screening visit without inflating enrollment counts.

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Q

What is the appropriate OnCore status for subjects that are in follow up and won’t have additional procedures?

A

Follow up is a valid status in OnCore.

Q

Will I still change the status of my subjects in APeX?

A

No. Study subject statuses must be changed in OnCore.  This information will be automatically transmitted to APeX for all subjects with an active consent date entered.

Q

Do we still have to upload Informed Consents into APeX? For surgical discard specimen collection protocols too?

A

Yes, all ICFs must be uploaded into APeX; it is a hospital regulatory requirement.

Q

How does coverage analysis work with this expansion?

A

The coverage analysis billing determinations are sent from OnCore to APeX to aid in the correct segregation of charges in APeX for patients who are associated with a research study.

Q

What do we do for trials with mixed billing or split billing?

A

All subjects for these trials need to be entered into OnCore.

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Q

Ongoing studies are required to be tracked.  Will this create a problem with double billing for appointments that have already occurred (i.e. past appointments)?

A

No, OnCore will only push new events into APeX.  There is also a team of billing scrubbers who are responsible for reviewing bills before charges are dropped to ensure double billing does not occur.

Q

What is the billing team’s process and how will it change?

A

Bills for every patient linked to a research study go through a bill scrubbing process.  Someone from the Research Revenue Cycle Team manually routes charges according to the coverage analysis.  This process will be streamlined by the bridge between OnCore and APeX.  The coverage analysis/billing grid will be pushed into APeX and used to pre-bucket expected charges. This will make it easier to match charges to the coverage analysis before any bills are released.

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Q

What happens if there was a procedure in APeX that was not listed on the coverage analysis (e.g. patient had a CT scan during a research visit, and this scan was not listed in the coverage analysis)?

A

The bill will be placed on hold.  The Research Revenue Cycle Team will contact the study team to get more information and determine how the charge(s) for that procedure should be routed.

Q

How will billing be impacted if subject visit data is not entered within 24 hours of the visit?

A

There could be billing errors.  You should register your participants and track visits in a timely manner to ensure proper billing.

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Q

Is billing affected by a subject status of on-study vs. on-treatment?

A

No.

Q

Has anything changed regarding how procedures will be billed?

A

Currently, there is a billing team that manually reviews all bills before they are routed to the correct payor.  This review is based on the coverage analysis.  The billing team’s job will be easier now that the coverage analysis is automatically transferred to APeX.  This change will not impact study teams or patients.

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Q

How is billing affected by recording a visit as missed vs. planned?

A

No charges are expected for a missed visit.  A planned visit is expected to have research activity on a certain date.

Q

Will this remove the need for billing scrubbers?

A

No, there will still be a team of billing scrubbers to ensure charges are routed correctly.

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Q

Does billing have to match the coverage analysis?

A

Yes, this is a compliance requirement.

Q

How will this new system impact billing that occurs via a recharge system (e.g. research radiology billing)?

A

Recharge billing occurs outside of APeX so this will not be impacted.  These patients should be tracked in OnCore because the visits occur within Medical Center space.

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Q

My patient screen failed, but there were research procedures during the screening visit.  Does APeX recognize how to bill even if the patient is listed as off-study because of the screen failure?

A

Yes, APeX will recognize how to route charges for the screening visit.

Q

Can anyone with access to the School of Medicine Library see any protocol within the SOM?

A

No, you can only see the protocols with which you are associated.

Q

My study had multiple protocol amendments and there were multiple versions of the study calendar.  How can I see the different calendar versions?

A

OnCore defaults to showing the latest calendar version. 

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Q

How are lab tests such as a chemistry panel listed on the protocol calendar/coverage analysis?  A chemistry panel can have multiple component tests.

A

The individual components of the chemistry panel will be listed if the blood is processed at the local lab.  The chemistry panel will appear as a single line if the blood is analyzed by a central lab. 

Q

How will I have access to the protocols I need?

A

Someone, usually the PI or senior administrator on the study, requests a CRC be added to a study protocol through the OnCore Team ([email protected]).

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Q

What happens if there is not a predictable number of visits before the end of the study (e.g., study continues until there is disease progression, which can be a variable number of treatment cycles depending on the patient)?

A

The protocol calendar in OnCore should auto-populate additional visits when the protocol calendar runs out of cycles.  Please contact the OnCore help desk if this doesn’t happen.  Contact the Intake team if there was a protocol amendment to add more visits/extend the study.

Q

What happens if we have an existing calendar build, but there is an unexpected scan that the sponsor agrees to pay for?

A

This should be routed back to the OCTA Intake team so the coverage analysis can be amended.

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Q

My study has multiple arms for different therapeutic areas (melanoma cohort & lung cohort).  These arms are handled by separate study teams and there are two zz accounts.  How can both teams track visits?  Can we charge two zz accounts?

A

The study may need to have two separate protocol builds.  Please reach out to [email protected] to discuss options.  Please bring this type of situation to the attention of the OCTA team when you request a calendar build for brand new studies.

Q

Who is the contact person if we think there is an issue with an existing protocol calendar?

A

Please contact [email protected] or [email protected].

Q

What is the purpose of the eligibility checklist and is it required?

A

The eligibility checklist can be tailored to individual studies and is used to capture eligibility data. It is not required to be entered into OnCore.  If there is an eligibility checklist entered in OnCore, OnCore will not set the subject status as Eligible without all eligibility criteria being indicated as met.

Q

Are the protocol eligibility checklist and informed consent pre-populated in OnCore or do we have to add these?

A

The OCTA Intake team uploads the informed consent form for every protocol.  Eligibility criteria are entered into OnCore via an Eligibility Survey; the OnCore Team is available to help Study Teams create Eligibility Surveys if they would like. Whether a study team wants an eligibility checklist is typically discussed when the protocol calendar is being built – eligibility checklists are not required.

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Q

Is entering eligibility criteria required for ALL participants or just those who are eligible?

A

Only subjects who have met the eligibility requirements will be enrolled. Subjects can be Consented even if they are NOT Eligible, however they cannot move further in the Enrollment Process until they become Eligible (e.g. they turn 18).

Q

How do the consents get into the “Available Consents” window? Do you put them there first?

A

“Available Consents” are included as part of the IRB reviews added to the protocol. In the Cancer Center, IRB reviews are added by the ITR regulatory team. Other study teams either add their own or ask OnCore team for assistance.

Q

Is there linkage between the CHR iRIS and OnCore? If not, is there a plan to create one?

A

Currently there is no linkage between the two systems. Yes, we do plan to connect these systems in the future.

Q

What information is communicated between OnCore & APeX?

A

Patient demographic data is pulled from APeX into OnCore.  Basic protocol information and the coverage analysis billing grid is pushed from OnCore into APeX.

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Q

My study uses a central IRB; does the UCSF IRB need to know if there is a protocol amendment?

A

No, the UCSF IRB does not require notification. Because the external IRB will review them, amendments do not need to be submitted to the UCSF IRB.

Q

Are there any Medical Spaces that are designated as non-billable research space?

A

Yes, there are a small number of designated research clinics, such as the CRS clinics and the Neurology Clinical Research Center.

Q

What do we do if we have an exception/special situation?

A

Please send all questions to [email protected].

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Q

What if my patient is coming to UCSF for the first time and does not have a UCSF Medical Record Number (MRN)?

A

The MRN is required before the subject can be registered in OnCore.  An MRN will be generated when a patient is registered for an appointment at UCSF, or if you need to request an MRN yourself, contact Hospital Admissions at 415-353-1488.

Q

Who should the department contact to get a space designated as a non-billable research space?

A

This would be difficult to do if the space wasn’t originally designed as a research space.  Contact [email protected] for further discussion.

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Q

What training is available?

A

eLearning modules and regular weekly webinars are available via UC Learning. Please contact the OnCore team at [email protected] with any questions.

Q

Does the subject enrollment requirement affect sub-sites for a UCSF study?

A

No, this only applies to visits that occur within UCSF Medical Center space.

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Q

My study was reviewed by an external IRB.  OnCore says it cannot recognize the study.

A

Contact the OCTA Intake team for assistance at [email protected].  They can confirm whether a coverage analysis was built and they can coordinate with the OnCore team to see if there is an issue with your access privileges.