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Quality Assurance Study Review Process
For Center for Veterinary Medicine (CVM) to conclude that a new animal drug is safe and effective, the submissions, study reports, and data provided by drug sponsors must be credible and reliable. CVM reviews data from Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) studies to determine whether these studies are of high quality and integrity and should be used to support safety and effectiveness decisions. This process has always been a part of the submission review process at CVM. In 2015, Office of New Animal Drug Evaluation (ONADE) in CVM introduced a program for quality assurance study reviewers (QASRs) to evaluate study quality and data integrity to build consistency across divisions and teams in the evaluation of the data quality. The QASRs perform study reviews on submissions that contain effectiveness, safety (including target animal safety and human food safety), or bioequivalence studies with data.
The quality assurance study review is conducted in two parts: the submission screen and the full study review. Submission screen starts after the Refuse to Review/Refuse to File assessment has been completed and when the studies are considered acceptable for review. It is conducted to confirm that all necessary documents and data are included for each study in the submission. If significant deficiencies are identified, the QASRs will provide “Transmit to Sponsor” comments and ask the primary reviewer to request an amendment. After submission screen is completed and the study is considered acceptable for an in-depth review, the full study review will commence. The full study review is conducted to confirm if the study was conducted according to the applicable standards, 21 CFR Part 58 (GLP) or CVM Guidance #85 Good Clinical Practice VICH GL9, protocol and protocol amendments (if any), and standard operating procedures; and if the final study report accurately reflects the raw data. The full study review will also provide an assessment of study and data quality and identify any issues of the study or data quality that should be further evaluated through a Bioresearch Monitoring (BIMO) inspection, or addressed by the submission of additional information by the sponsor.
CVM has created a policy & procedure document (P&P) that the QASRs use for completing their reviews available publicly. See P&P 1243.3215 on Requesting a Quality Assurance Study Review from the Quality Assurance Team.
QASRs also presented an overview of this review process at the 35th Society of Quality Assurance (SQA) Annual Meeting and Quality College in Atlanta GA, on May 1, 2019. See Demystifying the QASR Process.
If you have question about CVM/ONADE’s data quality program please contact the Leader of the Quality Assurance Team, Dr. Michelle Kornele at Michelle.Kornele@fda.hhs.gov.
Data Quality Webinar Q&A
The Center for Veterinary Medicine (CVM) held a public Data Quality Webinar in 2013. Questions were asked during and after the webinar. CVM created a Question and Answer Document to capture those questions and CVM's answers. Topics related to data quality were discussed in the document including eSubmitter, study protocols, investigational drugs/test articles, raw data, electronic data capture systems, data capture forms, adverse events, masking, statistics, sponsors' GLP (Good Laboratory Practice) compliance statements, study conduct, and the final study report. In October 2014, the Data Quality Webinar transcript, presentation slides, and the Question and Answer Document were published. Since then, these resources have been available to the public and are critical resources for stakeholders.
In response to questions from stakeholders, CVM reviewed the Question and Answer Document and updated answers to eliminate outdated information and provide more current references where appropriate. The updated Question and Answer Document for the Data Quality Webinar was made available in April of 2021. The original 2013 Data Quality Webinar transcript and presentations are also available. CVM did not make revisions to any of the questions and only revised some answers. If you have questions about these documents, please contact the Leader of the Quality Assurance Team, Dr. Michelle Kornele at Michelle.Kornele@fda.hhs.gov.
Submission of Electronically Captured Data
CVM requires that sponsors submit study data, including data collected manually and electronically through an electronic data capture (EDC) system, to support the new animal drug applications. Sponsors often have questions regarding electronic data submissions and have requested meetings with CVM/ONADE to discuss these questions with the EDC data submissions. Based on the questions that were commonly asked of CVM and the issues identified during the study review, the EDC related questions and issues that were commonly seen in submissions were presented at the SQA annual meeting in 2019. The EDC related information is included on Slides 43-61 in the presentation.
CVM/ONADE has also developed several points for sponsors to consider when evaluating EDC systems and their use in regulatory studies. The information is included on Slides 62-66 in the presentation.
CVM is committed to simplifying submission preparation for sponsors by providing a suggested documentation framework, including a sample structure on how to describe and organize the information regarding the electronic data files and statistical analysis program files. The information can be located in the Guidance for Industry #197 – Documenting Electronic Data Files and Statistical Analysis Programs. It provides information regarding recommendations for documenting electronic data files and statistical analysis submitted to CVM.
Additionally, the CVM eSubmitter program is a free, question-based tool that allows animal drug sponsors to submit information electronically and securely to the CVM. The eSubmitter’s standardized templates structure the necessary information in a consistent manner. For more information on data submissions to CVM via eSubmitter, refer to the CVM eSubmitter Program.
Pilot Program: Read Only Access to Electronic Raw Data
CVM recognizes that submitting copies of electronically-captured raw data can provide unique challenges to industry. In an effort to reduce these challenges, CVM has initiated a pilot program where CVM reviewers are granted read-only access to electronic raw data in lieu of submitting copies of electronically-captured raw data. A series of points that sponsors should consider when considering participation in this pilot program were developed and presented during the QASRs presentation “Demystifying the QASR Process” at the 35th Society of Quality Assurance Annual Meeting and Quality College in 2019. These questions are included on Slides 67-72 of the presentation.
Additionally, a workflow has been developed to help sponsors understand the process of the pilot program. Sponsors should contact the Leader of the Quality Assurance Team, Dr. Michelle Kornele at Michelle.Kornele@fda.hhs.gov to discuss details of logistics of the pilot program prior to submission.
Bioresearch Monitoring (BIMO) Program
BIMO inspections provide necessary assurance regarding the overall quality and integrity of studies submitted to FDA. See Bioresearch Monitoring Program (BIMO) Compliance Programs.
CVM has designated BIMO Coordinators with a goal of harmonizing BIMO processes throughout CVM and serving as a bridge between ONADE and OSC to enhance consistency and predictability of CVM requested BIMO inspections. The Requests Coordinator is in ONADE while the Inspections Coordinator is in the Office of Surveillance and Compliance (OSC).
QASRs have begun participating in BIMO inspections. The goal of participation is to provide additional assurance regarding the overall quality and integrity of studies conducted at the study site. With previous QA experience in industry, QASRs are able to provide support in assessing quality systems at inspected facilities.