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Data Quality Resources

On this page:

The Importance of Data Quality
Quality Assurance Study Review Process
Data Quality Webinar Q&A
Submission of Electronically Captured Data
Pilot Program: Read Only Access to Electronic Raw Data
Bioresearch Monitoring (BIMO) Program
Outreach and Resources

The Importance of Data Quality

High data quality is critical for regulatory studies so that CVM or other regulatory bodies can be confident that the information submitted for these studies is accurate and reliable and can be used to make regulatory decisions. Whether a study is conducted to support target animal safety, effectiveness, bioequivalence, environmental impact, manufacturing, or human food safety (if applicable), a regulatory study should be conducted in compliance with the protocol and all applicable standards of conduct, should be conducted by qualified individuals, should employ good documentation practices, and should be summarized in a comprehensive accurate and complete final study report. Good documentation practices ensure study documentation has all the attributes of ALCOA, being attributable, legible, contemporaneous, original, and accurate. Regardless of method of data collection, data quality and integrity should be maintained for all data from the time of collection through to submission of the data to CVM.

Quality Assurance Study Review Process

For the 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 conducted under Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) studies, as well as other standards of conduct, to determine whether these studies are of high quality and data integrity and should be used to support regulatory decisions. This process has always been a part of the submission review process at CVM. In 2015, the previous Office of New Animal Drug Evaluation (ONADE) (currently the Office of New Animal Product Evaluation (ONAPE) and the Office of Generic Animal Drugs (OGAD)) 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) on Requesting a Quality Assurance Study Review from the Quality Assurance Team (P&P 1243.3215).

The QASRs presented an overview of the QASR review process in the Demystifying the QASR Process presentation along with the top ten findings in paper and Electronic Data Capture (EDC) System studies, the ONAPE/OGAD EDC Remote Access Pilot Program at the SQA (Society of Quality Assurance) annual meeting in 2019, as well as noted revisions to the answers in the Question and Answer Document from the 2013 Data Quality Webinar updated in April 2021, that was presented in the QASR Hot Topics at the SQA annual meeting in 2023.

Additionally, the QASRs, along with primary scientific reviewers, provided an overview of CVM’s study review process from the perspective of the scientific reviewer and QASR perspectives in the One CVM Animal Drug Review Lifecycle presentation (starting on page 16 of the linked presentation) at the SQA annual meeting in 2023. 

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, in 2020 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 and the presentations are also available. CVM did not make revisions to any of the questions and only revised answers for applicable questions. 

The QASRs presented on and clarified important revisions to the updated answers and address common questions from the webinar in the QASR Hot Topics presentation at the SQA annual meeting in 2023.

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 animal drug applications. Sponsors often have questions regarding electronic data submissions and have requested meetings with CVM to discuss these questions. CVM presented on common questions and issues related to EDC in the 2019 Demystifying the QASR Process presentation at the SQA annual meeting in 2019.

CVM 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 Demystifying the QASR Process 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 and the eSubmitter user guide for file specifications.  

Pilot Program: Read Only Access to Electronic Raw Data 

CVM recognizes that submitting copies of electronically-captured raw data through eSubmitter 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 contemplate when considering participation in this pilot program were developed and presented during the QASRs presentation “Demystifying the QASR Process” at the SQA Annual Meeting in 2019. CVM also provided an update and current status on the pilot program during the QASR's presentation QASR Hot Topics at the SQA annual meeting in 2023.

A workflow has been developed to help sponsors understand the process of the pilot program. Sponsors interested in participating the EDC Remote Access Pilot Program should review CVM’s questions regarding participation in the pilot program. If a sponsor has identified a candidate study and would like to pursue participation in the pilot program, they can submit a meeting request to the appropriate (J)INAD file with an agenda that includes their answers to CVM’s questions and any additional questions or information the sponsor would like CVM to address. CVM will determine if the study is appropriate for participation at the meeting or provide a decision in the acknowledgement letter accompanying the memorandum of conference for the meeting. For any questions about the pilot program, please contact the Quality Assurance Branch Chief, Dr. Michelle Kornele.

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 product review divisions and compliance staff to enhance consistency and predictability of CVM-requested BIMO inspections. The Requests Coordinator is in ONAPE while the Inspections Coordinator is in the Office of Surveillance and Compliance (OSC).

QASRs and other CVM subject matter experts (SME), such as veterinary medical officers, may participate in BIMO inspections. The goal of SME participation is to provide additional assurance regarding the overall quality and integrity of studies conducted at the study site. 

CVM provided updates on the CVM BIMO program and highlighted the role of BIMOs in CVM’s animal drug review lifecycle in the CVM’s Bioresearch Monitoring (BIMO) Program presentation at the SQA annual meeting in 2023.

If you have questions about the CVM BIMO program, please email AskCVM at askcvm@fda.hhs.gov. 

Outreach and Resources 

The QASRs have provided multiple presentations on CVM’s data quality program and process to multiple venues to help stakeholders conduct and submit high quality submissions to CVM. Copies of relevant presentations and topics the presentation covers are included below. 

Society of Quality Assurance Annual Meeting:

Annual Aquaculture Drug Approval Coordination Workshop 

  • Good Documentation Practices: Overview of Good Documentation Practices (GDP) and common GDP errors seen in submission and best practices for recording study data. 

2024 ADUFA Educational Conference 

Helpful Documents

If you have questions about CVM/ONAPE’s data quality program please contact the Branch Chief of the Quality Assurance Branch, Dr. Michelle Kornele at Michelle.Kornele@fda.hhs.gov.
 

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