Sponsor Naming Conventions and Office for Clinical Research Mission
Office for Clinical Research's mission is to support the clinical research team. OCR Pre-Award Division plays a crucial role in managing research billing compliance and study budgets for Emory. Consistency in data fields, especially the Sponsor field, is essential for data integrity.
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SPONSOR NAMING SPONSOR NAMING CONVENTIONS CONVENTIONS Presenters Susan Pease and BeBe McCoy November 11, 2015 1
OFFICE FOR CLINICAL RESEARCH MISSION The mission of the Office for Clinical Research (OCR) is to facilitate operational processes that support the efforts of the clinical research team in the timely initiation, management and completion of clinical trials at Emory.
OCR Pre-Award Divison Responsible for research billing compliance and for the development of a prospective reimbursement analysis (PRA). Develop and negotiate study budgets on behalf of Emory study teams for the purpose of initiating clinical research studies at Emory or at an Emory-affiliated institution.
OCR Pre-Award Division Pre-Award staff are part of the beginning of the process in OCR, and they are responsible for the majority of initial study data information entry into OCR s respective databases.
OCR Pre-Award Division Consistency within the data fields are imperative for the purpose of data integrity. An extremely important data field is the Sponsor of a clinical research study, Indicates a federal vs non-federal funding source. Allows improvements for data mining. Improves budget negotiation processes.
Bristol-Myers Squibb, Bristol-Meyers Squibb, Bristol-Myers-Squibb, Bristol Myers Squibb, BMS, etc.
CURRENT (BASELINE) CONDITIONS Sponsor Naming Conventions Totals Sponsor Naming Conventions Percentages from March - August 2015 55 49 48 47 6% 32 Sponsor Naming Conventions - Incorrect 28 21 20 16 21 40% 32 Sponsor Naming Conventions - (Variations or Dual Sponsors) 12 30 27 13 19 18 15 Sponsor Naming Conventions - Correct 7 2 2 2 2 0 54% March April May June July August Monthly Totals Sponsor Naming Conventions - Correct Sponsor Naming Conventions - (Variations or Dual Sponsors) Sponsor Naming Conventions - Incorrect
GOAL: AIM STATEMENT Streamline the process to reducing the inconsistencies and variations between the databases so the transition to OnBase will be effortless. Improve the accuracy of the Sponsor Naming Conventions to 90% while reducing the inconsistencies and variations by 40% when entering the sponsor into the OCR databases by the end of FY 2015.
COUNTERMEASURES Action/Test of change Outcome/what was learned? Create Master Sponsor List for Pre-Award to copy/paste sponsor name into Sponsor field in database for all their active studies. The countermeasure revealed: Standardizing the process disclose a significant improvement within a month of entering the Sponsor Naming Conventions in the databases. The test of change acknowledged a reduction with the inconsistencies and variations by 29%. The test was somewhat successful. The reason dealt with the lack of time after implementing the new process.
PRE-AWARD PROCESS ADJUSTMENT On September 23, 2015 we introduced to Pre-Award the new process: -Utilize the OCR OnBase Sponsor List when naming the SPONSOR for all assigned active studies in the OCRLog. This document was provided both in hard copy and electronic form and on the share drive for reference. Whenever new sponsors needed to be added to the list an executive level of management must approve the addition.
PRE-AWARD PROCESS ADJUSTMENT COPY PASTE
METRICS/RESULTS Sponsor Naming Conventions Monthly Totals September 23, 2015 - October 31, 2015 Sponsor Naming Conventions Percentages from September 23,2015 October 31, 2015 Sponsor Naming Conventions - Incorrect Sponsor Naming Conventions - (Variations or Dual Sponsors) Sponsor Naming Conventions - Correct Monthly Totals 38 Sponsor Naming Conventions - Incorrect 5% 25% 28 Sponsor Naming Conventions - (Variations or Dual Sponsors) Sponsor Naming Conventions - Correct 70% 10 8 6 3 2 1 September October
FOLLOW UP/NEXT STEPS The new process implemented in Pre-Award benefited the Data Intergrity Department within OCR, mainly because now it eliminates the discrepancies between the databases with the Sponsor Naming Conventions when activating studies in PowerTrials - POM.
PROJECT SCORING Category Points available Criteria Aim statement 2 How much, by when, on whom = 2, Two of these = 1 Metrics 2 Annotated data on run chart = 1 Use of >1 PI tools (flow, fishbone, etc.)= 1 Tests of change 2 One TOC = 1 > 1 TOC = 2 Reliability 2 Use of Reliability Design Strategy = 1 Use of human factors in design to achieve >90% reliability = 1 Effective use of tools 2 Used A3 format correctly = 1 Use of quantitative data to drive TOCs = 1
