Standardizing data within the Inspection Site Selection Process
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 This need has been addressed in the published draft guidance, “Guidance for Industry: Providing Submissions in Electronic Format — Summary Level Clinical Site Data for CDER’s Inspection Planning.”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.
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
|Jane Lozano||Steering Committee Liaison||Eli Lillyemail@example.com|
|Patty Gerend||Project Leader (Retired)||Genentech Incfirstname.lastname@example.org|
|Jean Mulinde||FDA Co-Lead||FDA - CDER||Jean.Mulinde@fda.hhs.gov|
|Nate Freimark||CDISC Co-Lead||The Griesser Groupemail@example.com|
|Parag Shiralkar||PhUSE Co-Lead||Independentfirstname.lastname@example.org|
Conference Calls and Minutes
Conference Call Schedule and Call in details
WG2 Wiki Revisions
Last revision by Laurenwhite,09/28/2017