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- btained.
Background
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PI Dept. Reviews to Approval & Signatures Time Line: Mar. 2014 – Oct. 2014
Background CLINICAL TRIAL AGREEMENT ACTIVITY TIME TRACKING PI / - - PowerPoint PPT Presentation
Background CLINICAL TRIAL AGREEMENT ACTIVITY TIME TRACKING PI / - - PowerPoint PPT Presentation
Background CLINICAL TRIAL AGREEMENT ACTIVITY TIME TRACKING PI / Department Reviews Other Intermountain Reviews Approvals & Signtures Manage and Close Step 1: Step 1a: Step 1b Step 1c Dept Step 2: Step 3: Step 4 : Step 5: Step 6 :
SLIDE 2 CLINICAL TRIAL AGREEMENT ACTIVITY TIME TRACKING
Step 1: Sponsor sent Clinical Trial Agreement (CTA) to PI Step 1a: PI sent CTA to Dept Clinical Trial Project Manager (if applicable) Step 1b Dept approval of the Clinical Trial Study Step 1c Dept negotiations with Sponsor complete Step 2: PI (or Project Manager) sent CTA to Office of Research (OOR) Contract Manager Step 3: PI or Dept sent completed Contract Intact Form (CIF) to OOR Step 4: OOR revised CTA and sent to Sponsor Step 5: Sponsor sent back CTA to OOR Step 6: OOR completed CTA negotiation with Sponsor Step 7: OOR delivered Contract Approval From and Legal Check List to Legal Dept Reviewer Step 7a: Legal Review suggested further revisions Step 8: OOR sent Contract Approval Form to other Reviewers for signature Step 8a: Other Reviewers suggested further revisions Step 9: All Intermountain Approvals, excluding AVP Research, are
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Intermountain Research Contracting Process
Mission Statement: To define, establish, and implement a high quality clinical trial agreement process that is efficient, transparent, and compliant.
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Team 1 Monte Crockett, JD; Counsel II Ahsen Khan, JD; Contract Manager Mike Mayer, MBA; Business Development Director Team 2 Tom Graydon: Academic Services Director Patti Spencer: Cardiology Research Manager Peggy Reed: Women and Newborn Research Manager
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Process Flow Chart – Part I
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Individual People Documentation Communication Departments Related Contracts Resources Accountability Other Reviews Role Confusion Meetings Signature Delega- tion Interactions Awareness Ownership Maintenance Accountability CDA IRB Application BAA DUA CTA Amendments Peoplesoft Maintenance Other Tools Volume Metrics Contract Types Contract Positions Intake Form Nomenclature & Definitions Legal Checklist Raj Summary Consent Form Paper Vs. Electronic
- Vs. In-Person
Meetings Formats Timeline Transparency Ownership Notifications Clinical Trial Agreement Process Improvement
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Leverage Points
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Change Hypotheses
- Add additional time with Legal Reviewer to
decrease contract backlog thereby decreasing time to contract execution
- Streamline the documentation required for
contract review to decrease roll confusion, reduce redundancy and increase efficiencies in the contracting process
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Change Hypotheses
- Collect data throughout the contracting process
to create timeline transparency and accountability
- Provide additional FTE/s for Contract Manager
to increase capacity and facilitate better communication
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Aim Statement:
Create a process that reduces the length of time to execute a research contract in the Intermountain Office of Research. By analyzing the current research contracting process, creating and implementing an electronic tracking system that collects research data and tracks contract timelines, we hope to reduce the length of time to complete a contract to no more than 30 days, create transparency within the contracting process for our stakeholders by the end of the Q1 2016. Additionally, we will establish a data-driven foundation that enables continuous measurement to further improve the Office of Research contracting process.
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PDSA Cycle #1
- Determine if adding additional time with Legal
Reviewer will decrease the contract backlog and decrease time to contract execution.
- Collect data for one month, study data, make
appropriate recommendations
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PDSA Cycle #1
- Added 6 hours of legal review time per week, for a
total of 8 hours per week (up from 2hour/week).
- Collected data for 1 month
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PDSA Cycle #1
- Analyzed the data and found that the review
capacity was greatly increased and the backlog dropped dramatically, even with the continuous influx of new documents for review.
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Contract Backlog for Legal Review
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PDSA Cycle #2
- Streamline the documentation required for contract review to
decrease roll confusion, reduce redundancy and increase efficiencies in the contracting process
- Create a REDCap database for tracking and data collection
- Collect data for 3 months throughout the contracting process
to create timeline transparency and accountability
- Study data and make appropriate recommendations
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PDSA Cycle #2
- Built REDCap database tool
- Obtained key stakeholder review, comments and buy-in
- Modified tool according to feedback received
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Team 1 Process Tracker
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RESEARCH LEGAL DOCUMENTS ACTIVITY TIME TRACKING PI / Department Reviews Office of Research - Legal and Other Reviews Approvals & Signtures Manage and Close
Step 1: Dept received document from Sponsor Step 2: Dept or PI sent Document with Intake Form to OOR Contract Manager Step 3: OOR sent revised Document to Sponsor Step 4: Document review completed by OOR and ready for legal review Step 5: Legal Review
- f Document
with OOR Step 6: Legal Review completed and Documentation Review Form Signed by OOR and Legal Step 7: OOR sent Documentation Review Form to
- ther Reviewers
for signature Step 8: All Intermountain Approvals, excluding AVP Research, are
- btained.
Step 9: OOR sent Document Summary Form and Documentation Review Form to AVP, Research for signature Step 10: OOR received AVP signatures for Documentati
- n Review
Form Step 11: OOR sent Document to Sponsor for signature Step 12: Fully executed Document is returned to OOR by Sponsor Step 13: OOR notified IHC PI or
- Dept. of fully
executed Document Step 14: OOR created Peoplesoft account for Project and notified Accounting Step 15: Peoplesoft account activated by Grants Accounting and Dept notified
CLINICAL TRIAL AGREEMENT ACTIVITY TIME TRACKING PI / Department Reviews Other Intermountain Reviews Approvals & Signtures Manage and Close
Step 1: Sponsor sent Clinical Trial Agreement (CTA) to PI Step 1a: PI sent CTA to Dept Clinical Trial Project Manager (if applicable) Step 1b Dept approval of the Clinical Trial Study Step 1c Dept negotiations with Sponsor complete Step 2: PI (or Project Manager) sent CTA to Office of Research (OOR) Contract Manager Step 3: PI or Dept sent completed Contract Intact Form (CIF) to OOR Step 4: OOR revised CTA and sent to Sponsor Step 5: Sponsor sent back CTA to OOR Step 6: OOR completed CTA negotiation with Sponsor Step 7: OOR delivered Contract Approval From and Legal Check List to Legal Dept Reviewer Step 7a: Legal Review suggested further revisions Step 8: O O R sent Contract Approval Form to- ther Reviewers for
- btained.
New Process Tracker
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Multiple Forms Required for each Contract
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Contract Intake Questionnaire (DRAFT)
To help me complete a quick and thorough review of the current agreement, please answer the following questions at your earliest convenience. I can derive any additional info I may need from the agreement and related materials/info. that will follow.
- Is this project sponsor or PI-initiated?
Y N
- Who is the Intermountain PI? ______________________
- Is our PI an Intermountain employee? (If our PI is a contracted physician,
I will need a copy of the physician group agreement for reference. I can help locate this.)
- Is our PI an MD?
Y N If Yes, is medical research included in his/her employment agreement? Y N (Be prepared to present documentation of this should it be requested. I can help you locate this if you don’t know where to get it.)
- In lay terms, what does this project entail? Does it involve patient
testing, or will it be a data mining study? Please be as specific as
- possible. (A few lines of space for free text.)
- Do you have IRB approval for the project?
Y N N/A If No and it is required, have you submitted your application to the IRB? Y N
Legal Review Checklist: Study Agreements/Subcontracts
Version 1
1.) PARTIES: Are all parties identified in the opening provision? Y N 2.) EMPLOYMENT: A.) Is the physician/employee employed by IHCHS or is the physician affiliated? Y N B.) If PI is a physician, is there an employment agreement verifying his/her authorization to perform research on behalf of Intermountain? Y N N/A 3.) CONFIDENTIALITY: A.) Do we have our preferred terms or the established alternatives including documentation from our PI relating to Intermountain Confidential Information and/or non-marked sponsor Confidential Information? Y N B.) Does the agreement provide for the return of study materials/drugs/etc. at the reasonable expense of the disclosing party? Y N N/A 4.) MEDICAL RECORDS: Does the agreement ensure that Intermountain retains ownership of its A.) patient medical records and/or original source documents? Y N N/A B.) peer reviewed/privileged documents? Y N N/A 5.) IRB: A.) Do we have IRB approval or has it been applied for? Y N N/A B.) Does the agreement include a provision stating that the agreement will terminate if the IRB does not approve of the proposed study? Y N N/A 6.) CHOICE OF LAW/VENUE: A.) Do we have one of the three preferred law/venue choices? Y N B.) Which was used: Utah Delaware Silent AGREEM ENT INFORM ATION: ID#: 068 Type of Agreement: Clinic al Tria l Agre em ent Other Party: Genom ic Health, Inc . Agreement Title: Study Agreem ent Indirect Rate: 53.5% Budget: Total Es tim ated Bu dge t: $ 251 ,20 5 ($2390 per pa tien t, p lus fee s ) Total Patients (if known): 100 Es tim ated Where to Sign: Study Agreem ent –p.7 CDR – bottom- f p.1
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Creation of REDCap Database
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Thank you to our Team Members
Sponsor: Raj Srivastava, MD, MPH; AVP of Research Project Team: Tom Graydon, Patti Spencer, Peggy Reed , Ahsen Kahn, Monte Crockett, Mike Mayer Frontline Team: Jill Quam, Jesse Whitfield, Heather Gallo , Jeff Sorensen, Research Teams Institute Staff: Ann Ward, Jean-Ann Wurtz, Brad Stephenson
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But What Did We Really Learn? Be Courageous!
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Wh What is the definition of courage?
- mental or moral strength to venture, persevere, and withstand
danger, fear, or difficulty – Meriam-Webster
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