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 : Step 7: Step 7a: Step 8: Step 8a: Step 9: Step 10: Step 10a: Step 10b: Step 11: Step 12: Step 13: Step 14: Step 15: Sponsor sent PI sent CTA to Dept approval of negotiations PI (or Project PI or Dept sent OOR revised CTA Sponsor sent OOR completed OOR delivered Legal Review OOR sent Other Reviewers All OOR sent CTA, OOR sent CTA to OOR received OOR received OOR sent CTA to Fully executed OOR notified IHC OOR created Clinical Trial Dept Clinical the Clinical Trial with Sponsor Manager) sent completed and sent to back CTA to OOR CTA negotiation Contract suggested Contract suggested Intermountain Contract PI for signature. CTA with PI AVP signatures Sponsor for CTA is returned PI (or Project Peoplesoft Agreement Trial Project Study complete CTA to Office of Contract Intact Sponsor with Sponsor Approval From further revisions Approval Form further revisions Approvals, Summary Form Signature for CTA and signature to OOR by Manager) of account for CTA (CTA) to PI Manager (if Research (OOR) Form (CIF) to and Legal Check to other excluding AVP and Contract Contract Sponsor fully executed and notified applicable) Contract OOR List to Legal Dept Reviewers for Research, are Approval Form Approval Form CTA Accounting Manager Reviewer signature obtained. to AVP, Research for signatures File Name Department Study Type Agreement Type \ 10.21.14 - Ware Branch - Jesse Whitfield W&N Clinical Trial - Industry CTA 3/19/2014 4/16/2014 10/13/2014 10/17/2014 10/22/2014 10/21/2014 10/22/2014 8.18.14 - Angie Schwab PM - Jesse Whitfield CV Clinical Trial - Industry CTA 6/13/2014 8/18/2014 8/20/2014 9/3/2014 10/3/2014 8.11.14 - Michael Charlton - Jesse Whitfield Transplant Clinical Trial - Industry CTA 7/31/2014 8/8/2014 8/8/2014 not available 1 9 15 - Erin Zinkham - Jesse Whitfield W&N Clinical Trial - non-Industry (federal, unive CTA 9/17/2014 1/5/2015 1/12/2015 not available 2 13 2015_TBD_SWOG_Whitfield Oncology Clinical Trial - non-Industry (federal, unive CTA 2/12/2015 no date available 2/13/2015 not available 9.8.14 - Julie Ballard - Jesse Whitfield Oncology Clinical Trial - Industry CTA 5/1/2014 8/25/2014 9/3/2014 9/9/2014 9/23/2014 10.8.14 -Robert Hoesch Partners Health Care- Jesse Whitfield Neuro Clinical Trial - non-Industry (federal, unive CTA 10/1/2014 10/2/2014 no date available 10.17.14 - B Hoesch Mr. Witness - Jesse Whitfield Neuro Clinical Trial - non-Industry (federal, unive CTA 10/7/2014 10/10/2014 10/16/2014 10/16/2014 10/27/2014 11/7/2014 10.23.14 - Prometheus Brent Muhlestein - Jesse Whitfield CV Clinical Trial - non-Industry (federal, unive CTA 10/22/2014 10/22/2014 10/22/2014 11/7/2014 11/26/2014 11.24.14 - Scott Woller - Amy Sikalis Pulmonary / CC Clinical Trial - Industry CTA 11/17/2014 11/18/2014 11/27/2014 12/4/2014 12.8.14 - Angie Schwab - Jesse Whitfield (guide-it POC) CV Clinical Trial - non-Industry (federal, unive CTA 7/8/2014 12/1/2014 12/1/2014 12/8/2014 12/22/2015 1/19/2015 12.8.14 -Robert Smilanich - Jesse Whitfield Other Clinical Trial - Industry CTA 10/31/2014 12/1/2014 12/16/2014 12/8/2014 1/27/2015 12.23.14 - D Budge - Jesse Whitfield (echo guide-it) CV Clinical Trial - non-Industry (federal, unive CTA 12/1/2014 12/23/2014 12/15/2015 1/5/2015 1/15/2015 PI Dept. Reviews to Approval & Signatures Time Line: Mar. 2014 – Oct. 2014 2
Intermountain Research Contracting Process Mission Statement : To define, establish, and implement a high quality clinical trial agreement process that is efficient, transparent, and compliant.
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
Process Flow Chart – Part I 5
Leverage Points Individual Documentation Communication People Accountability Intake Form Paper Vs. Electronic Vs. In-Person Nomenclature & Other Reviews Meetings Formats Definitions Role Confusion Legal Checklist Timeline Transparency Meetings Raj Summary Ownership Signature Delega- Consent Form Notifications Clinical Trial Agreement tion Process Improvement Interactions CDA Peoplesoft IRB Application Maintenance Awareness BAA Other Tools Ownership DUA Volume Metrics Maintenance CTA Contract Types Accountability Amendments Contract Positions Related Departments Resources Contracts 6
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 7
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 8
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. 9
P DSA 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 10
P D SA 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 11
PD S A 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. 12
Contract Backlog for Legal Review 13
P DSA 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 • 14
P D SA Cycle #2 Built REDCap database tool • Obtained key stakeholder review, comments and buy-in • Modified tool according to feedback received • 15
Recommend
More recommend
