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General Requirements / Timing
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 |
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. |
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. |
Enrollment
Visit Tracking
Definitions
Subjects, Teams, and Types of Studies Impacted
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. |
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.] |
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.] |
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. |
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. |
Data to be Entered into OnCore or APeX
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 |
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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. |
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. |
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. |
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. |
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. |
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. |
OnCore Questions
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. |
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. |
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). |
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. |
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. |
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. |
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. |
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. |
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. |
APeX Questions
Coverage Analysis / Billing
Protocol / Protocol Calendar
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. |
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]). |
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. |
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]. |
Eligibility Criteria / Checklist
Informed Consent Form (ICF)
Linkages to Other Systems
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. |
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. |
Miscellaneous
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]. |
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. |
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. |
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. |