This online training course was developed to provide users with a high-level overview of the proposed Corrective and Preventive Action (CAPA) process, including insights for auditors.
MDIC held its final Case for Quality Forum of 2019 on November 6 in Arlington, VA. Download slides from the forum below.
Welcome and Introductions
MDIC Case for Quality Overview
Strategic Foresight Session
Panel Discussion: VIP and Expansion
Presentation: MDIAS SafeSpace
Advanced Manufacturing Working Group Update
Fixing CAPA Working Group Update
VIP Working Group Update
NCS Pilot Working Group Update
Debrief and Q&A
Closing Remarks and Next Steps
February 26, 2020
In 2017 and 2019, MDIC collected metrics in the first ever collaborative sharing of Sponsor administrative data. Average time from the site packet received at the site to first patient enrolled was improved from 320 days to 252 days thanks to improvements in IRB review cycles and more timely first patient enrollment. However, contract negotiations between sponsors and sites – and more specifically reaching agreement on a study budget – actually worsened from an average of 133 days to 164 days. Reaching agreement on a contract and budget, a purely administrative (yet, critical) task in clinical trial setup is taking nearly six months in back and forth between sponsors and sites thereby delaying the actual performance of the clinical study.
MDIC has collaborated in two workshops with Baylor Scott & White Research Institute to develop an EFS Master Clinical Trial Agreement (MCTA) template to help sponsors and sites streamline this aspect of contracting. EFS Study Sponsors who have used the agreement report that contract negotiations based on the MDIC MCTA template have enabled some contract negotiations to be completed in as little as a month – a dramatic improvement.
MDIC sought to bring the same effort on improving the efficiency of sponsor-site budget negotiations as has been demonstrated in contracting. Budget negotiations are consistently troublesome and rank the highest of issues to address to streamline EFS studies going forward. On February 26, 2020 in Arlington, VA, MDIC led a workshop of leading sponsors and sites with extensive EFS experience to share EFS budgeting best practices and roundtable discussions to identify concrete improvement steps that can be taken.
The objectives for the one-day workshop were:
- Share leading sponsor and leading site best practices for timely and efficient EFS budget negotiations
- Consolidate these best practices and determine as a group those approaches that will make the biggest differences across the landscape of sites and sponsors
- Establish a working group from interested participants who want to standardize budgeting approaches and communicate them throughout the medical device clinical trial ecosystem
Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.
The NESTcc Methods Framework is applicable to many different data sources and defines the key components of a study protocol for the evaluation of medical devices.
The document promotes overall study design, outlining principles to follow and evidentiary requirements for core elements including disease and device information, target population and patient selection, study outcomes and procedures, sample size, monitoring and statistical analysis.
The NESTcc Data Quality Framework focuses primarily on the use of EHR data in the clinical care setting, and considers topics including data governance, characteristics, capture, transformation, and curation.
Within the framework, the NESTcc Data Quality Maturity Model addresses the varying stages of an organization’s capacity to support these domains, which allows collaborators to indicate progress toward achieving optimal data quality.
Parkinson’s patients Margaret Sheehan and Anne Cohn Donnelly, who participated as Patient Scientists on the MDIC Patient Centered Outcomes Research project team along with representatives from the Michael J. Fox Foundation for Parkinson’s Research (MJFF), the U.S. Food and Drug Administration (FDA), and MIT, provide their perspectives on how clinical researchers can best engage with patients in this white paper.
The EFS Express is a periodical eblast created to provide updates on the EFS Site Network Pilot along with educational materials. Past editions of the EFS Express can be found below.
- Edition 1 (2/21/19): Welcome to the EFS Express
- Edition 2 (3/21/19): EFS Site Best Practices Workshop Recap
- Edition 3 (4/30/19): EFS Resources and Tools
- Edition 4 (5/16/19): EFS Site Network Pilot 2019 Planned Activities
- Edition 5 (6/6/19): An Update from FDA on CDRH’s EFS Program
- Edition 6 (7/10/19): EFS Symposium Recap: Implementation Strategies for EFS
- Edition 7 (7/18/19): Don’t Miss Our Panel on EFS Datapoints at This Year’s Annual Public Forum
- Edition 8 (8/8/19): EFS Master Clinical Trial Agreement – 2019 Virtual Legal Roundtable Recap
- Edition 9 (10/4/19): Latest Data Shows Improvement in Some EFS Administrative Processes
- Edition 10 (11/14/19): Regulatory Roundtable Recap
- Edition 11 (12/10/19): A Year in Review for EFS
- Edition 12 (2/5/20): MDIC EFS: 2019 in Review and Plans for 2020
- Edition 13 (3/19/20): EFS Budgeting Best Practices Workshop – Sponsor Perspective
- Edition 14 (4/2/20): EFS Budgeting Best Practices Workshop – Site Perspective
- Edition 15 (4/9/20): EFS Budgeting Best Practices Workshop – Next Steps
- Edition 16 (5/7/20): EFS Success Story: Startup Finalizes EFS Contract with Brigham & Women’s in Less Than 3 Months
This white paper is the result of a collaborative effort of the Medical Device Innovation Consortium (MDIC), the medical device industry, strategy consultants, and the Food and Drug Administration (FDA). It brings together their perspectives and cultural and procedural best practices across various industries to recast the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The paper summarizes the initial findings and recommendations developed by the joint team, including a proposed framework for risk-based improvement. We recommend that industry participants test the framework in a live pilot. This paper does not constitute advocacy or lobbying or present recommendations on policy or political matters. Moreover, although FDA representatives on the program team are supportive of the framework, this paper does not represent conclusions or policy changes by the agency.