We would like to recognize one of our quality team monitors, Karen Lepuschenko, who recently earned the SOCRA certification. Karen has been at the SCI for a little more than two years now and is a valuable member of our team. The quality team is proud of Karen’s accomplishment. Way to go, Karen!
Coverage Analysis
The Stanford Healthcare Revenue Cycle (SHC) team is committed to enhancing the performance of clinical research operations. As a first step toward a more optimal Pre-Award future state, the SHC Revenue Cycle, in collaboration with Compliance, has been working on transitioning Coverage Analysis (CA) support from Ankura to Huron Consulting Group.
The timeline for this transition is accelerated. Many teams, including SCI-CTO, have been diligently working to fully onboard Huron and have them take over CA responsibilities for new studies. Studies that currently have coverage analysis completed by Ankura will remain with Ankura until the end of September, at which point Huron will assume further coverage analysis edits and amendments.
As shared by SHC Revenue Cycle team, Huron offers several key advantages to Stanford in meeting our objectives:
- Improved efficiency, speed, and cost: Huron utilizes a system to support baseline CA work across their customer base, and it has a best-practice process that facilitates significantly higher-level completeness on initial drafts to support budgeting.
- Greater process transparency: Huron offers a self-service intake platform that will provide transparency to your coverage analysis status, including CA specific email updates.
- OnCore Expertise: Huron has a dedicated team responsible for OnCore implementation and integration and is a preferred Advarra value-added partner, which will help support future OnCore workflows.
- Huron will provide training materials and job aids to support their Coverage Analysis process. We will inform you as we learn more about the next steps and the timing for the transition.
Thank you,
SCI-CTO leadership team
Stanford Cancer Institute Clinical Trials Office
As announced at the August staff town hall meeting, the SCI-CCTO has been renamed the Stanford Cancer Institute Clinical Trials Office (SCI-CTO). The change reflects unity and collaboration with the Stanford Cancer Institute organizational identity and is part of a larger renaming effort for Stanford Cancer Institute programs and events.
Please update your email signature and voicemail to reflect this change by the end of the month.
If you have any questions, contact Ages Nika or Sarah Pelta.
SCI-CTO Guideline Update: Opening a Single-center Investigator-Initiated Trial (IIT)
The SCI-CTO guideline “Opening a Single-center Investigator-initiated Trial” version 9 is released and available on Coordinator Corner (Study Start-up/Close Out tab, Overview section). The document, which describes the activities required in the development and activation of a single-center Stanford IIT, has undergone extensive changes from the prior version.
Scope: Single-center Stanford IITs
Training:
- Staff directly involved in opening and managing IITs should review the document thoroughly in order to apply the information to your work.
- Staff not directly involved in opening and managing IITs should review the document for awareness.
Please direct questions to DSMC-Quality@stanford.edu.
Q & A with QA
“Q & A with QA”Welcome to our first posting of “Q & A with QA” created by the Quality Assurance team. We believe all questions are important and if one individual has a question about something, then it’s likely others may have as well, or will at some point. We hope these blog posts will provide insight into common questions asked by study teams so that everyone can be included in the conversations. Of note, the questions we post are paraphrased and not taken directly from any one individual.
Question:
What is the best way to document that the treating investigator has reviewed and assessed safety labs (as clinically significant (CS) or not clinically significant (NCS))? We currently print the lab results for signing/dating by the treating investigator to document their assessment, but we would like to move away from paper. What are our options?
Answer:
Printing the lab results and having the investigator document their assessment if CS or not is certainly one reliable method.
- An alternative method to document the review of safety labs by the treating provider is via the electronic medical record. The lab results can be pulled into the progress note for the applicable study visit, in which the treating investigator can document that the labs were reviewed. If any out of range labs are present, the provider should indicate whether they are CS or NCS. This allows real-time documentation as the e-signature verifies when the documentation occurred (meets ALCOA*).
For example, some teams have created a specific smart-phrase and utilized this in documentation encounters to indicate how they are documenting lab result assessment. The labs that need to be assessed are incorporated in the progress note, and the investigator bolds/highlights the specific labs that are assessed as clinically significant. The smart-phrase will indicate “Clinically significant labs are bolded in red/highlighted”.
Please discuss among your team to find a feasible work flow.
* Elements of Good Documentation Practice (GDP)= ALCOA
Attributable, Legible, Contemporaneous, Original, and Accurate.
Want to keep the conversation going?
Please join us at our Wednesday 9:00-9:30 QA Virtual Chat Join from PC, Mac, Linux, iOS or Android: https://stanford.zoom.us/j/93986583586?pwd=WmsrOUc2VklFbGN4amp5amxGUDZwUT09
Password: 153280
Or please feel free to send your questions to: dsmc-quality@stanford.edu
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