This list will be continuously updated as feedback is received. Please check back periodically for updates.
Access to Study Documents: Transition from FYI to CTMS
Which protocols are required to upload documents to OnCore CTMS?
1. Oncology-related protocols (Oncology library in CTMS) with:
-
- Consent form documents, AND
- A Protocol Status of Open to Accrual, Closed to Accrual or Suspended
2. Protocols that have been sent to Epic.
-
- Epic status can be viewed in the PC Console > Status tab
3. Protocols that do not meet the above criteria may have documents uploaded, per discretion of study team
-
- Study teams may choose to upload documents to OnCore for version control and access
Does the Cancer Consortium Distribution of Current Consents Policy still apply?
The Distribution of Current Consents Policy is under review. The expectation is that our institutional requirements will align with federal regulations which require use of the currently approved consent form.
Who will access documents from OnCore CTMS?
Any user who currently uses Clinical FYI to access protocol documents will have an account created for them in OnCore CTMS. Any SCCA clinic staff involved in the implementation review of protocols or the validation of Beacon Treatment plans will access draft documents and manuals in OnCore.
Additional users can request accounts through the CTMS onboarding form. All users who need access to protocol documents are welcome to use OnCore, including ancillary services staff, clinic staff, study teams, and administrators.
What documents will be required to be uploaded?
1. The following documents will be uploaded to the PC Console > Documents/Info > Attachments/Links tab:
-
- Lab Manual
- Imaging Manual
- Pharmacy Manual
- Product Manual
- Apheresis Manual
- Other Manual
- Billing Grid
- RN Fact Sheets
2. The following documents will be uploaded to the PC Console > Reviews > IRB > IRB Review Update tab (under the IRB review where the document was approved):
-
- Protocol
- Consent(s) and Assent(s)
- Investigator’s Brochure
- Protocol Memos and Clarification Letters
- HIPAA Authorization Form
- Additional documents as desired
How can we search OnCore CTMS for documents?
You can search for documents with any of the following protocol identifiers:
- Protocol Number (RG#)
- IRB Number
- Pharmacy Number
- Sponsor Number
- IND Number
- IDE Number
- Investigator
- Keywords: Any word found in the title, short title or objectives
Who do I contact if a document in OnCore is missing or the version is not correct?
If a document is missing from OnCore you can contact the CTMS office at CTMS@fredhutch.org or contact the study team’s Regulatory Coordinator directly. Contact information for the Regulatory Coordinator (and other staff) is found in the protocol staff list. Users will have access to the staff list, which is located in PC Console > Main > Staff tab of the protocol.
Will other Clinical FYI documents still be available in CORE (e.g., BMT documents, etc.)?
Only protocol document access is moving from CORE FYI to OnCore CTMS. Other CORE functions are not changing.
Can we still print the consent footer and date of printing?
The functionality to print a consent footer will be available in OnCore CTMS when document access goes live.
Will protocol documents currently in FYI be moved into OnCore?
Documents will be migrated from FYI to OnCore before go-live. Following migration study teams will be responsible for reviewing and releasing these documents for access. Study teams may opt-out of this migration by management group if they choose to upload their own documents by emailing CTMS@fredhutch.org.
Do I need a new user ID and password to access documents in OnCore CTMS?
Current OnCore CTMS users will continue to use their existing login credentials to access OnCore.
Current FYI users who do not have access to OnCore will be contacted by the CTMS Program Office to arrange access prior to go-live. For questions please contact us at CTMS@fredhutch.org.
After go-live, Fred Hutch, University of Washington (UW) or Seattle Cancer Care Alliance (SCCA) employees needing access to OnCore may submit a CTMS Onboarding Form. An active HutchNet ID, UW NetID or SCCA username and password are required to OnCore access.
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.
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.
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.)
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.
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.
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.
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”.
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.
Data Validation
For go-live purposes, please indicate the earliest consent date.
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.
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.
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.
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.
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.
We do not need On Follow Up or Off Study dates for subjects who did not enroll into studies (i.e. screen fails).
The CTMS Program Office will update all deceased patients as Off Study using the deceased date as the Off Study date.
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.
General CTMS
What are the Targets and Timing for Implementation of the CTMS?
The implementation strategy is divided into two targets:
- Target #1: Subjects & Protocols – UW/FH Cancer Consortium Oncology & FH Non-Oncology
- Target #3: Study Calendars & Financial Management + UW Non-Oncology
Timing for each Target varies. Currently:
- Target #1 went live July 2018
- Target #3 will go live Sept. 18, 2021
When will my study team be live in the CTMS?
Target 1: UW/FH Cancer Consortium Oncology studies and FH Non-Oncology study teams went live in 2018 as part of Group 1 (July 16, 2018) or Group 2 (September 17, 2018).
Target 3: UW Non-oncology studies will go live in Sept. 13, 2021.
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.
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.
We are assessing the appropriate workflow for this scenario and will have more information later in summer of 2018.
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.
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.
No.
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.
New Study Intake, Activation, & Amendment Processes
Are there any changes to the required sRAMP submission documents?
No, there are no required document submission changes. We encourage staff to attach all relevant documents with their initial submission to prevent delays later in the process.
What is the replacement for sRAMP document management?
Working documents will be uploaded via the REDCap Intake Form. Any new or modified documents will be submitted via REDCap as well. The Amendment Decision Tree Survey will tell you where to do that. Final Billing Grid will be available on the OnCore Activation/OTA Task list in the PC Console > Status > Task Lists tab and in Clinical FYI.
If the study has not been submitted to sRAMP prior to go live on June 1st, the study team will need to submit a REDCap Study Intake Form. The RG number auto-generated by the REDCap form will be updated with the RG number already assigned in OnCore.
Where will the link to the REDCap Study Intake Form live? What are the log-in requirements?
The link will live on both the CRBB website and the OnCore Announcements landing page. There are no log-in requirements for the form itself.
For OnCore studies, the link to the amendment form will be stored in the PC Console > Documents/Info > FAQs tab of the OnCore protocol record.
No, OnCore does not support that level of version history.
No, the CTO Informed Consent review only includes billing compliance level review, verifying alignment with billing grid and other documents, and Medicare Secondary Payer (MSP) language.