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Quality Assurance Study Review (QASR) Process
For Center for Veterinary Medicine (CVM) to determine 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 with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) studies to help demonstrate the studies are of high quality. 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 review on submissions that contain effectiveness, safety (including target animal safety and human food safety), or bioequivalence studies with data. The review starts after the Refuse to Review/Refuse to File assessment has been completed and when the studies are considered acceptable for review.
The quality assurance study review is conducted in two parts: the submission screen and the full study review. Submission screen 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 review 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 FDA regulations, 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 made the policy & procedure document (P&P) that the QASRs use for completing their reviews available publicly. See P&P 1243.3215 on quality assurance study review.
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 Quality Assurance Team Leader, Dr. Michelle Kornele at Michelle.Kornele@fda.hhs.gov.
Data Quality Webinar Q&A
A Data Quality Webinar was held in June 2013 at Kansas State University to address issues with the data submissions received by CVM. Answers to questions asked of CVM during the presentation or submitted after this webinar were provided in a Q&A document. The question topics ranged from study conduct to submission and included the following topics: general information, eSubmitter, study protocol, investigational drug/test article, raw data, electronic data capture systems, data capture forms, adverse events, masking, statistics, sponsor’s GLP compliance statement, study conduct, and final study report. See the Data Quality Webinar, including the 2013 Q&A document.
Electronic Data Submission
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 their concerns with the EDC data submissions. Based on the questions that were commonly asked of CVM and the issues identified during the study review, common 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 simplify 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 Draft 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 electronically and securely submit information 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 test 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 work flow has been developed to help sponsors understand the process of the pilot program. Sponsors should contact CVM/ONADE to discuss details of logistics of the pilot program prior to submissions.
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. One is in ONADE and the other 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.