Study Start-Up - Department of Pediatrics start-up can be complex and loooong! ... Dept. of Peds ....

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 (sethg@umn.edu)

• 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 mandrews10@umphysicians.umn.edu Jana Langan, Discovery Clinic Manager jlangan10@umphysicians.umn.edu Allison Hudson, Explorer Clinic Manager ahudson10@umphysicians.umn.edu Erin Friedman, Journey Clinic Manager efriedma10@umphysicians.umn.edu

Reach out to Clinical Partners

Inpatient, Unit 4: Ann Hagerman ahagerm1@fairview.org

Fairview Ancillary Departments Lab: labresearch@fairview.org Ashley Bestul: abestul1@fairview.org Pathology: pathresearch@fairview.org

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: – IDSPharmacy@fairview.org – IDStechnician@fairview.org

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