Standardizing data within the Inspection Site Selection Process

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Welcome to the Wiki for the FDA/PhUSE Computational Sciences (CSS) Working Group (WG) "Inspection Site Selection Standard Data Elements". Our Working Group's completed document on the gap analysis between expectations and current CDISC standards is published below under "Project Deliverable". Also below you can find descriptons of various aspects of our WG and activities.


The past two decades have witnessed a dramatic growth in the size and complexity of the clinical trials enterprise, posing challenges for FDA in maintaining its traditional inspectional approaches. These challenges include, but are not limited to: an increasing number of sites per clinical trial, an increasing number of foreign clinical trial sites, finite resources limiting the number of inspections, PDUFA timelines requiring a high level of efficiency, and variation in the current site selection methodology. To address these challenges, FDA is working to modernize and enhance the efficiency and effectiveness of its inspection processes. For example, FDA’s Center for Drug Evaluation and Research (CDER) has developed and is piloting a risk-based inspection site selection tool. This tool combines data from sponsor and FDA databases to quickly analyze and assess clinical site level data contained within an application to identify clinical sites for inspection early in the review process. This need has been addressed in the published draft guidance, “Guidance for Industry: Providing Submissions in Electronic Format — Summary Level Clinical Site Data for CDER’s Inspection Planning.” The specific data elements were identified in a companion technical document entitled “Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning”.

While some of the information detailed in the guidance may be available within an NDA or BLA, it may not be in a format that allows it to be readily repurposed into a dataset to be used for analysis in CDER’s Clinical Site Selection Tool. A PhUSE working group was formed in March 2012, led by Michael Brennan, and charged to do a detailed analysis of each of the proposed elements that have been requested by CDER. The group focused on a couple of key points:

- Providing a clear definition of each of the data elements that CDER needs to complete its site-selection analysis. This will facilitate generation of the information by enabling sponsors to 
  unambiguously identify the sources of the information and will support consistent interpretation across sponsor companies.  
- Providing an assessment of whether the requested data elements are consistent with already established clinical data standards CDISC SDTM and ADaM.

Due to changes in job responsibilities, some of the original active members of our team were no longer able to continue the project, so it was on hiatus for a while. At the 2015 FDA-PhUSE CSS, WG teammates re-connected, including industry and FDA staff, and found that there was enthusiastic agreement to complete the team’s mission. Some former team members re-joined and new ones were brought on board.

Please see below under "Leadership and Team" for current/recent team membership and under "Conference Calls and Minutes" for completed activities.

Project Deliverable

Gap Analysis May 2016

Objectives and Timeline

Our WG's primary objective is to complete the gap analysis between what FDA needs and what CDISC currently provides with respect to information needed for FDA to identify sites to audit via their software tool. Once accomplished, the gap analysis will be submitted to CDISC for consideration of developing site-level domains and other relevant standards.

Gap analysis document has been completed and is posted above under "Project Deliverable".

Leadership and Team

Name Role Organization E-mail
Jane Lozano Steering Committee Liaison Eli Lilly
Patty Gerend Project Leader (Retired) Genentech Inc
Jean Mulinde FDA Co-Lead FDA - CDER
Nate Freimark CDISC Co-Lead The Griesser Group
Parag Shiralkar PhUSE Co-Lead Independent
Betsy Fallen Industry
Bhanu Kannan FDA
Colleen Davenport Industry
Christina Casteris Industry
Dany Guerendo Industry
David Izard Industry
Erika Liu Industry
Janet Lowe Industry
Kassa Ayalew FDA
Ketan Durve Industry
Kenneth Westervelt Industry
Michael Johnson FDA
Paul Schuette FDA
Sara Pauwels Industry
Tony Chang Industry
Julie Maynard Industry
Anne Russotto Industry
James Gaiser Industry
Melissa Brinz Industry

Conference Calls and Minutes

WG2 30JAN2012


2015-2016 Meeting Minutes

Conference Call Schedule and Call in details

  • 25Jun2015
  • 11Aug2015
  • 09Sep2015
  • 18Nov2015
  • 24Feb2016

WG2 Wiki Revisions

Last revision by Laurenwhite,09/28/2017