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Study Start-Up: Workflows and Expectations
Amanda Galster, MPH, CCRP Clinical Research Program Director
April 6, 2017
We are all here to conduct high quality medical
research in children,
in the hope that what we learn
will make a difference
Study start-up can be complex and
loooong!
Learn the new processes & tools, & who can help.
AHC starting to look at metrics
Many Inter-connected Components
IRB
$$
POTENTIAL new projects
POTENTIAL new projects
POTENTIAL new projects
POTENTIAL new projects
POTENTIAL new projects
PROPOSALS Peds RSS
We Got It !?! Yeah ?!?
First Things First: Regulatory
• Do you have everything you need? – Protocol – Investigator Brochure (if applicable) – IND / IDE info – Draft CFs
• Helpful to know expectations of the groups who will need to review the project – HRPP, CPRC, or other scientific review – IRB, IBC – Ancillary Reviews
First Things First: Finance
• Do you have everything you need? – Protocol / Schedule of Events – Draft agreement / contract – Draft budget / Work Order / Payment Schedule – Is the budget negotiable??
• Who are your Finance Friends? – CTFS – Department GAs and/or Accountants – Administrator
First Things First: Clinical
• Do you have everything you need? – Protocol – Investigator Brochure (if applicable) – Manual of Procedures (MOP) – Pharmacy Manual – Lab Manual
• HINT: determine early on what clinical services you need and where they should be done
Recommended Workflow
• There does not exist one comprehensive diagram or list.
• There are many inter-connected pieces.
• The details are continuously changing.
CTR Portal Registration
• Do this first to get your CTSI # – Needed for OnCore Protocol Number
• Needed to route for HRPP review, requesting various CTSI services, Portal time-tracking
Service Requests in CTR Portal
• Can be done right away of you are ready, or you can come back and complete later
• HRPP Scientific Assessment • BioNet • BDAC • MCRU, DCRU • LCRU • Participant Recruitment • And more
OnCore?
• AHC-required “Minimal Footprint” • https://www.ctsi.umn.edu/researcher-resources/clinical-trial-management-
system/studies-enter-oncore – Studies under Health and Biological/Medical IRB Application – Studies under Social and Behavioral Sciences IRB Application – Studies under Medical Record Chart Review IRB Application
with individual subject study specific consent forms – Any other research studies using Fairview or University of
Minnesota Physicians services OR billing to research participant or third party (i.e., insurance)
OnCore Registration z.umn.edu/oncoreguide • Link to internal
OnCore web page • User Guides!!!
OnCore Registration
https://oncore.umn.edu • OnCore system login
page • Support Links
Need a Calendar? Want a Calendar?
• Refers to specific functionality in OnCore • Calendars are built by CTFS
• REQUIRED for: – Studies using Fairview / UMP services – Basis for the needed Billing Grid
• OPTIONAL for: – Any other study where a calendar may be helpful
to you for tracking participants
CTFS – Clinical Trials Financial Services
• Service unit in CTSI • Formerly referred to as “the Hub” • Finance team dedicated to clinical research
– Budget development – Budget negotiation – Contract routing to SPA
REQUIRED For Industry-
sponsored studies in
Dept. of Peds
CTFS Workflow Initial Email: • Send required documents
to Seth Goldberg ([email protected])
• Cc Deb Reid
Helpful to include: • Contact info for Sponsor
contact(s) • Start-up time estimates for
PI and staff
ISW – Internal Subject Worksheet
• Portion of Excel workbook used by CTFS to develop study budget
• You will need to work with the PI (and maybe many others)
• Take the TIME to do this RIGHT!
Reach out to Clinical Partners
Contacts for Pediatric Specialty Clinics: Beth Andrews, Director [email protected] Jana Langan, Discovery Clinic Manager [email protected] Allison Hudson, Explorer Clinic Manager [email protected] Erin Friedman, Journey Clinic Manager [email protected]
Reach out to Clinical Partners
Inpatient, Unit 4: Ann Hagerman [email protected]
Fairview Ancillary Departments Lab: [email protected] Ashley Bestul: [email protected] Pathology: [email protected]
Other Fairview Research Contacts: https://www.fairview.org/fv/groups/internet/documents/web_content/s_034225.pdf
Calendar Sign-off
• From the ISW, CTFS will complete the calendar build
• Research team needs to review and sign-off – Can test
• Sign-off triggers notification to Fairview/UMP – Triggers IDS, lab, etc. – Triggers FRA to review Billing Grid – Triggers pricing
Budget Negotiations
• Be aware of all the work that will be needed – Scheduling, planning, conducting study visits – Specimen and data management – Adverse Event monitoring – Monitor Visits – Outside safety reports
• Stand your ground, justify with facts
NEXT: Regulatory
• Once protocol is off for Scientific Review and CTFS is developing your budget
• UMN IRB? Or Central IRB? • Start with the Consent Forms
– Need to be pre-approved by Industry Sponsors – IRB has new templates
• Then IRB’s new Site Supplement
Using Central IRBs
• Will be required for NIH awards – Sept? • Many sponsors and coordinating centers are
requesting the use of a single IRB • We may use Quorum IRB for some Industry-
sponsored studies • Requires local evaluation
– Ancillary Reviews – Reliance Application
Using Central IRBs
HRPP Toolkit Library
• IRB policies – http://www.irb.umn.edu/policies.html
• worksheets, checklists, templates – http://www.irb.umn.edu/toolkit.html
HRPP Toolkit Library
HRPP Toolkit Library
• SOPs, worksheets, checklists, templates – http://www.irb.umn.edu/toolkit.html
• Investigator Manual • IRB standard procedures for review, management, and
how they function • Evaluation forms used by IRB staff and Reviewers • Worksheets used by IRB Staff and Reviewers for specific
reviews and topics • Checklists for documenting regulatory items that must
be documented & considered by the IRB
ETHOS
• New electronic submission & IRB management system
• Go Live March 27th • Required for new studies • Transition of existing studies later this year
ETHOS
Developing a Protocol
• The IRB’s new system and workflows require each study to have a PROTOCOL. – Templates available
• Medical template • Social template • Data or Specimen-Only template
• For studies with an external protocol, we must complete a “Site Supplement to Sponsor Protocol”
OnCore: IRB Reviews
• Most helpful if you enter IRB reviews information in real time
• Helps you track, and helps our entire research community know what is happening with your study
• User Guide: “Protocol Reviews” • Initial Review & Approval
– Required before you can “Open” in OnCore – Triggers Fairview to set-up Epic account
Initial Protocol Set Up
Update ‘Reviews’ to
advance Protocol Status to “IRB Initial
Approval”
Send Eligible
Protocol to Epic (via
interface)
Study accounts created
(billing, lab, etc)
Register new subjects to
Protocol using “Find
Fields”
Record “Signed
Date(s)” for Consent(s)
Subject Enrolled to study (real
time)
OnCore / Epic Integration Research Coordinator Billing Functions
Enter Appointments/ Admissions,
etc. for clinical
services
Link Appointme
nts/ Admissions,
etc.
Subject receives services
Occur visit
Review linked
charges and bill
accordingly
OnCore Epic
Study and Participant interface
Demographics interface
OnCore: Protocol Sign-off
• Required after “Initial IRB Approval” and before “Open to Accrual”
• Important QA check that all required information is entered
• User Guide: Sign-Off Checklist – Includes AHC and specialty areas requirements
SIV: Site Initiation Visit • Industry sponsors will require an on-site SIV • Good best practice for all types of studies • PI and primary CRC are required to attend
– Also include: co-investigators, back-up CRCs, etc. • Schedule IDS in advance – allow for 1 hour • May also need tours or meetings with lab,
radiology, etc. • CRC training: data entry, specimen management,
electronic systems, etc. – Ask questions!
Don’t Forget: IDS • Include IDS in the SIV • Use IDS # in all communications • Remember to send the following regulatory
documents to IDS pharmacy: – Pharmacy Manual – Approved consent form – Signed 1572 form and/or DoA
• They need to know who are the authorized prescribers!
• Communicate: – [email protected] – [email protected]
OnCore: Open to Accrual
• Required before you can register individual participants
• “Open” date should reflect that actual date you are able to start screening/enrolling – IRB approval – Executed Contract – Training & SIV complete – Ready Clinically (have specimen kits, drug, orders)
• User Guide: Protocol Statuses & Checklists – Includes AHC and specialty areas requirements
OnCore Workflow: Notifications by Protocol Status
Why so many new requirements?
• UMN, AHC, MCC, & CTSI need to understand and report on our research portfolio.
• IRB changes in response to… • CTMS is an important tool to manage our
work and ensure compliance with regulations and policies.
• METRICS
Minimal Footprint • OnCore Minimum Footprint elements were identified to aid in: Research Portfolio visibility, analysis and oversight for Departments, Central
Groups (i.e. CTO, CTSI) and Leadership. Integration with other data sources (i.e. TASCS, CTR Portal, SPA, EPIC)
Process flows and intersections (i.e. Billing for Service Providers, Financial Management)
• OnCore Enterprise team is driving QA processes to ensure
Minimum Footprint elements are captured. – Minimum Footprint refinement efforts are planned.
Minimal Footprint • Resources Available:
– Pediatrics Definitions and Requirements Guide – OnCore User Guides Page (see Required Fields & Definitions) and Protocol Signoff
Checklist. https://sites.google.com/a/umn.edu/umnoncoreuserguide/
Timeline Metrics University goal is to reduce the time from research concept to discovery.
• Newly added to the Enterprise Minimum Footprint are some additional data points to track timelines. – New Protocols need to capture these (effective January 2017).
• These timeline data points were added to improve visibility to how long various research activities take (reporting being built).
• Metrics will measure length of time from Protocol Finalized -> Study Closure with key inputs along the way. – Scientific/IRB Reviews, Budgeting & Contracting Processes, & Recruiting (i.e. 1st
Subject Enrolled).
Task Lists • An OPTIONAL tool is being deployed in OnCore to help research teams.
– Note: Existing task lists will be required for use by Service Providers and CTFS to capture key budgeting and contracting timelines.
• OnCore functionality allows teams to use Task Lists within OnCore to identify activities that need to occur in the research process. Examples:
– Obtaining Regulatory Approvals – Study Close-Out Activities – Administrative and Clinical Start-Up, etc.
• Phase I Deployment:
– Central “checklist” of activities with task description, generic role owner and suggested sequence.
– Links and attachments to direct you to additional resources (webpages, forms, etc.)
– Opportunity to track dates so cross-functional team has visibility to status. • Tasks lists can be used to “remind” you of activities without requiring you to populate completion
dates.
Task Lists • Task lists are being developed based on SME input, existing
department checklists, SOPs, etc. – Susan Anderson is representing Pediatrics.
• Deploying throughout 2017. – Releasing in Production as built.
• Available Now: Regulatory Approvals • Currently Finalizing: Close-Out • Upcoming: Administrative Start-Up, Clinical Start-Up, Open to Accrual, Preparing for Monitoring
Visits/Audits
– Training available from OnCore team. – Future enhancements will deployed later (Phase II) as Forte refines functionality.
• i.e. Ability to calculate target dates, improved reporting, usability enhancements.
Task Lists in OnCore
Activities
Owner
Can capture dates completed and add notes.
Additional Reference Materials
SUMMARY
• Study initiation can be complex • There are people around to help you • Involves Regulatory, Financial, and Clinical
processes and considerations • Compliance with new requirements • Tracking and Reporting will help to
demonstrate our research activities and to tell our story
Any Questions?
Timeline Metrics Metric Existing
Requirement/ Workflow
New Requirement
Situationally Dependent *All Studies required to Capture Enterprise Minimum Footprint*
Location Reasoning Notes
Protocol Finalized
All Studies* Annotation CTSA Requirement
CPRC/SRC Submission to Approval
OnCore
Functionality requires Submit
date and Approval if SRC Required =
Yes
Committee is not
systemically required in OnCore
today
Studies using Locally constituted mechanisms (i.e. CPRC) or HRPP Scientific Review to fulfill IRB Scientific Assessment Requirement. *Not Required for Nationally-based, federal funding organization reviews OR Nationally based non-federal funding organizations.
Reviews Key Input Area (Required for many Domains today and by OnCore functionality)
Calendar Request ->Complete ->SignOff
Studies using Calendar Task List & Specification Status
Existing Workflows
Billing Grid Designation Verified
Studies using 3rd Party Services (Fairview/UMP)
Task List Existing Workflows
Pricing Completed
Studies using 3rd Party Services (Fairview/UMP)
Task List Existing Workflows
Timeline Metrics Metric Existing
Requirement/ Workflow
New Requirement
Situationally Dependent *All Studies required to Capture Enterprise Minimum Footprint*
Location Reasoning Notes
Budget Draft Started to Budget Complete
CTFS to Capture
Non-Investigator Initiated, Business & Industry studies using Calendars in OnCore
Task List
Key Input Area
Contract Received to Finalized
SPA to Capture
Business & Industry studies EFS (SPA) - CTSA Requirement*
- Key Input Area
IRB Submission to Approval
All Studies* Reviews - CTSA Requirement
- Current Requirement
Open to Accrual
All Studies* Status Current Requirement
First Subject Date
If using Subject
Tracking in OnCore
For studies
tracking Accrual Only
All Studies* Individual Subject Tracking = Subject Data
Accrual Level Tracking = Annotation
CTSA Requirement
Timeline Metrics Metric Existing
Requirement/ Workflow
New Requirement
Situationally Dependent *All Studies required to Capture Enterprise Minimum Footprint*
Location Reasoning Notes
Study Close to Accrual
All Studies* Status
Current Requirement
End of Subject Activities
All Studies* Main > Details Primary Completion Date
Current Requirement
End of Data Collection
All Studies* Main > Details Study Completion Date
Current Requirement
Study Closure Date
All Studies* Status IRB Study Closure
Current Requirement
Metric Definitions New Fields Definition Date Protocol Finalized Date Protocol Received from the sponsor OR, if investigator initiated trial, the
date the protocol was finalized by the Investigator (in ready state for Scientific Review). -CTSA modified definition
Pricing, Calendars, Billing Grid Designation Verified
Date of initial calendar request, date of protocol calendar signoff, pricing complete date, billing grid designation verified date based on 1st completed pricing cycle.
**Subsequent iterations or amendments to tracked separately, including # of iterations/amendments, average time to complete**
Budget Draft Started Date inputs were received to begin preparation of the budget OR the date the pricing was completed.
Budget Finalized Date Budget was finalized (with all inputs from University) and approved by the Investigator and the Sponsor.
Metric Definitions New Fields Definition Date Contract Received The date the draft protocol, draft contract and signed (expedited) PRF were
received by Sponsored Projects Administration (SPA). – SPA proposed
Date Contract Negotiated The date the contract wording (terms & conditions) were mutually agreed upon between the Sponsor and Institution. – SPA proposed
Date Contract Fully Executed
The date the contract is fully signed and executed by all involved parties (Institution, Sponsor and PI (if applicable)) – SPA proposed
Date of First Subject Accrual The first subject is the first research subject is put “On Study.” The date of the first subject accrual is the date on the consent form for that first subject. If the protocol includes multiple sites managed by the University of Minnesota, the earliest first subject visit at any site should be used as the FS date. - CTSA Common Metrics (CM) Operational Guidelines modified for OnCore terminology/workflows.
Per existing OnCore definitions: • CPRC/SRB Submission and Approval Per existing minimum footprint definitions: • IRB Submission, IRB Approval, Open to Accrual, Study Close to Accrual, End of Subject Activities, End of Data
Collection, Study Closure Date.
Regulatory Task List
Regulatory Task List
Regulatory Task List
