The VICH GCP Consultancy Blog

When FDA Inspections Trigger Data Risk: What CVM’s OAI Classification Really Means

Tue, 28 Oct 2025 21:57:13 GMT

�� When FDA Inspections Trigger Data Risk: What CVM’s OAI Classification Really Means

The FDA’s Center for Veterinary Medicine (CVM) has released a detailed procedure outlining how and when it classifies bioresearch monitoring (BIMO) inspections as Official Action Indicated (OAI) —a designation that can signal serious concerns about data integrity and regulatory compliance.

�� What Is an OAI Classification?

An OAI classification means FDA inspectors found objectionable conditions that may warrant regulatory action. In the context of veterinary drug development, this could include:

Data rejection during application review
Disqualification of clinical investigators
Termination of investigational exemptions
Invocation of the Application Integrity Policy (AIP)

Importantly, not all data issues stem from violations of law. Even non-regulated practices —like poor data handling or unclear study conduct—can lead to administrative consequences if they undermine the validity of submitted data.

�� Inspection vs. Application Decisions

FDA distinguishes between inspection findings and application decisions:

A study may be rejected without an OAI classification if the data is scientifically inadequate.
Conversely, an inspection may be classified as OAI even if no application has yet been submitted, based on the potential impact of observed practices.

�� What Happens After an OAI?

If an inspection is classified as OAI, CVM’s Office of Surveillance and Compliance (OSC) will issue a Data Concerns Letter. This letter:

Notifies the inspected firm of the classification
Describes the conditions that may compromise data integrity
Offers the firm a chance to respond and correct issues
Alerts sponsors to potential risks at contract research sites

In cases where the issues could escalate—such as repeated errors or systemic failures—the letter may also warn of possible future disqualification or AIP proceedings.

��️ Why This Matters

For sponsors, CROs, and investigators, understanding the implications of an OAI classification is critical. It’s not just about compliance—it’s about safeguarding the validity of your data and the viability of your submissions.

This procedure reinforces FDA’s commitment to transparency, consistency, and scientific integrity in veterinary drug development. It also serves as a reminder: even in areas not governed by specific regulations, good research practices are essential.

Reference: www.fda.gov/media/188278/download?attachment

If you have any questions, please contact us for an expert discussion tailored to your organisation’s needs.

Raising the Bar for Veterinary Clinical Studies

Sun, 26 Oct 2025 21:15:29 GMT

What VICH GCP Can Learn from ICH E6(R3)

Raising the Bar for Veterinary Clinical Studies

The release of the updated ICH E6(R3) Good Clinical Practice guideline marks a pivotal shift in how clinical studies are designed, conducted, and evaluated. While VICH GCP remains the cornerstone for veterinary studies, especially those intended for regulatory submission, the innovations embedded in E6(R3) offer valuable lessons that could elevate the quality, efficiency, and transparency of veterinary research.

What can we learn?

Embracing Quality by Design (QbD)

ICH E6(R3) introduces Quality by Design as a key principle, urging sponsors to proactively identify and manage “critical-to-quality” factors that impact participant safety and data reliability.

VICH GCP Opportunity:

Veterinary clinical studies could benefit from embedding QbD into protocol development, especially for complex designs like adaptive (rare disease studies, dose finding studies) or multi-site studies (field studies with variable conditions). This means:

Defining quality objectives early (e.g. implementation of real-time QC of critical laboratory parameters).
Mapping risks to animal welfare and data integrity (e.g. owner non-compliance with visit schedule).
Aligning monitoring plans with critical endpoints (e.g. set triggers of >48h lag in reporting of AEs to escalate to Sponsor medical monitor).

Proportionality and Fit-for-Purpose Approaches

E6(R3) emphasizes that study procedures and documentation should be proportional to the risks and complexity of the study. It also introduces the idea that data need not be error-free if conclusions remain robust.

VICH GCP Opportunity:
This principle could streamline veterinary clinical studies by:

Reducing unnecessary documentation for low-risk studies (e.g. post-marketing studies).
Encouraging pragmatic designs for field studies (e.g. dispensing product at routine visits/handling timepoints).
Supporting flexible SOPs that reflect the individual study (e.g. permit remote monitoring via teleconference for low-enrolment sites).

Strengthening Data Governance

The new guideline expands on data governance, including oversight of computerized systems, data integrity, and sponsor-investigator responsibilities.

VICH GCP Opportunity:
Veterinary sponsors can:

Implement clearer roles for data custodianship (e.g. user permissions in the EDC aligned with task ownership matrix).
Validate electronic data capture systems with veterinary-specific metrics (e.g. protocol data points to EDC fields and edit check are all aligned and practical).
Enhance audit trails for sample tracking and lab data (e.g. automated time-stamps at collection, packaging, shipment, and receipt at lab if critical to the study).

Reframing Stakeholder Roles

E6(R3) redefines responsibilities across sponsors, investigators, and ethics committees, with greater emphasis on collaboration and oversight.

VICH GCP Opportunity:
Veterinary clinical studies often involve diverse stakeholders—veterinarians, farm managers, CROs, owners etc. VICH could:

Clarify shared responsibilities in multi-site studies (e.g. define escalation paths and site-specific oversight in the monitoring plan).
Develop training modules for non-experienced investigators, farm managers, owners.
Encourage ethics review processes tailored to the individual study.

Updating Terminology and Documentation

The new glossary in E6(R3) replaces “subject” with “study participant” and updates definitions to reflect modern study conduct.

VICH GCP Opportunity:
Veterinary GCP could:

Modernize terminology (e.g., “animal participant” vs. “study subject” vs. “case”).
Align documentation templates with E6(R3) structure (e.g., protocol appendices, essential records required for submission to the different authorities etc.).
Build bilingual glossaries for global harmonization.

Final Thoughts

While VICH GCP rightly reflects the unique ethical and operational demands of veterinary research, the E6(R3) revision offers a blueprint for modernization. By selectively integrating its principles—especially around QbD, proportionality, and data governance—VICH could better support innovation in animal health clinical studies.

For sponsors, CROs, and regulators working across human and veterinary domains, this is a golden opportunity to harmonize best practices and raise the bar for ethical, efficient, and inspection-ready research whilst being mindful of protecting the interest of the individual animal, safety of the consumer and protecting the environment.

Please contact us for an expert discussion tailored to your organisation’s needs.

RQA International QA Conference, Foundations First: Quality Reconstructed Conference Review!

Wed, 04 Dec 2024 18:15:05 GMT

Foundations First: Quality Reconstructed Conference Review!

RQA Animal and Veterinary Products Committee, Effective Management of Deviations workshop was presented by industry experts from GxP auditing services, Hurst Animal Health and yours truly! During the workshop audience members were placed into teams and asked to determine if the presented scenario would be an amendment, a deviation or documented as a study note to file. Then each scenario was assessed for impact, root cause analysis, CAPA and what effectiveness checks could be performed. It was interesting to get the opinions from colleagues from other GxPs.

RQA Animal and Veterinary Products Committee, Panel discussion: Asia-Pacific Experiences and, separately, FDA-Inspections in EU was delivered by industry experts (Zoetis, Elanco and Argenta) based on their experience and views. This honest discussion was very open. There was discussion surrounding inspection preparation and readiness, as well as hot topics which inspectors may look for.

RQA Animal and Veterinary Products Committee “Coffee Talks” , are planned quarterly for 2025. These FREE EVENTS will further discuss topics directly relating to VICH-GCP, including deviations handling and impact in final study reporting, preparing for inspections and also having events where the topic is left open so attendees can ask their own questions and gain insight from seasoned professionals. If you want to know more and be added to the circulation list – then get in touch ( sm@vichgcp.com ) .

If you would like to learn more about The VICH Consultancy and the range of services we offer, visit the Our Services page on our website or click the button below.

Pre-Clinical Studies - the need for VICH GCP compliance?

hello@keyam-digital.co.uk (Lorna Blakey) — Tue, 03 Dec 2024 21:19:37 GMT

Pre-Clinical Studies - the need for VICH GCP compliance?

Pre-clinical studies in veterinary clinical trials defined:

Also called ‘non-clinical’ studies these studies precede clinical studies; usually in vitro and in vivo (animal) studies, where different aspects of the test product, including safety and efficacy, are evaluated. These pre-clinical studies usually are the first time the product is evaluated for effectiveness in the target species.

Is VICH GCP compliance needed?

Technically, not all pre-clinical studies have to be performed to VICH GCP.

However, VICH GCP can apply to all studies, in the introduction to VICH GCP it states that it can be applied to "all clinical studies of veterinary products in the target species" .

The idea behind VICH GCP is promoting a high-quality standard to the conduct of running a study. Thus, ensuring a robust and valid data set which will hold-up against any regulatory inspection.

Having said that, please note that pre-clinical studies are mostly performed at or by facilities which have other internal standards, such as GLP. More facilities like these are adopting levels of VICH GCP into their setting. When their internal systems do not allow this then the study will be run to the " spirit " of VICH GCP. These additional system requirements include a greater focus on data validation and quality control.

It would be recommended for consideration by the Sponsor that if the study is considered pivotal then it is performed to VICH GCP. So, for a dose confirmation study - this would be performed to VICH GCP. However, if the study is for proof of concept or perhaps a "dose finding" study then perhaps you can set aside VICH GCP if you are assured of the systems and checks in place to record and report the data in a valid manner and to other quality standards.

Concluding Remark: Ultimately it is up to the Sponsor to determine the quality standards applied to each individual study and have this balanced against other factors such as cost, facility/ CRO availability and facility/CRO documented quality standards.

As Sponsor it would be recommended that a qualification audit of the facility/CRO is conducted ahead of the study and that a data management plan, audit plan and monitoring plan is utilised to ensure all parties know the level of data recording, QC, validation and QA expected at each stage of data handling.

Explore our all-inclusive offerings, including monitoring, quality assurance, project management, and protocol/report writing, tailored for the animal health industry.

vGCP Trials and Tribulations! So We Start at the Beginning Part 2: What does VICH GCP Tell Us?

Thu, 10 Oct 2024 09:05:14 GMT

What does VICH GCP cover?..

Key Players

There are several key roles in a VICH GCP study: the “Sponsor”, the “Investigator”, the “Monitor” and the “Quality Assurance Auditor”. VICH GCP defines their responsibilities.

Study Design and Planning

VICH GCP states that study sites should have adequate facilities and qualified personnel capable of conducting the study according to the protocol.

In VICH GCP field studies, the Investigator usually is a veterinarian with access to either client-owned animals from their clinic population or to farms for which they are the responsible veterinarian.

Often however, the true driver behind site selection is case recruitment – can the site recruit the animals needed for the study?

Study Protocols

VICH GCP describes the structure of a compliant study protocol. Other guidelines should be consulted for content of the protocol such as directives, EMEA guidelines, monographs, etc. as well as obtaining scientific advice.

The study protocol should state the objectives, design, methodology, and procedures of the study.

This study protocol should be based on the VICH GCP guidelines and include information on the study population, dosage, treatment regimen, sample size calculations, endpoints, statistical analysis, and safety monitoring.

The study protocol should be subjected to ethical review and approval, ensuring that the study adheres to the principles of the 3Rs (Replacement, Reduction, and Refinement) and is conducted in compliance with relevant animal welfare laws and regulations of the country in which the study will be performed.

Data Management and Monitoring Quality Control

Establishment of a robust data management system to collect, record, and analyse study data is critical to the success of any study. This system should be compliant with the principles of VICH GCP and include procedures for data entry, quality control, data validation, and data security.

If the data management system is electronic (Electronic Data Capture System), then this should also be validated and compliant with any required regulations e.g. 21 CFR Part 11.

Such systems have in-built edit checks to ensure the consistency of data recording which negates some potential human-errors, but electronic systems may not be suitable for all field-situations (cost and practical considerations).

The validity of the data is verified by the Monitor conducting regular data checks and by visits to the study sites to verify that the study is being conducted according to the protocol, VICH GCP guidelines, and animal welfare standards.

Monitors should review source documents, data, and study procedures to ensure that the study is proceeding as planned and that deviations are properly recorded and addressed.

Quality Assurance

VICH GCP is supportive of a quality assurance (QA) program that includes audits of the study sites and data management processes. The extent of QA involvement will depend on the project; however, critical phases audits should be performed.

The QA auditor should be independent of the study personnel and responsible for identifying and correcting any issues that could impact the study's validity.

Reporting

Once the study data is collected and the final efficacy data set determined, statistical analysis will be performed, according to the protocol requirements, to establish the safety and efficacy of the test product.

A final study report is compiled that reports what actually happened on the study and includes all study data, analysis results, and conclusions.

This report should adhere to items listed VICH GCP guidelines, following submission it will be reviewed by the regulatory authorities.

vGCP Trials and Tribulations! So We Start at the Beginning Part 1: VICH GCP Explained in a Nut Shell!

Mon, 07 Oct 2024 08:56:24 GMT

“What is VICH GCP?” - Surprisingly, I get asked this, A LOT!

Whilst game-changing blockbusters are rare, this is the aim, and to get there we conduct studies according to the VICH GCP guideline (alongside a plethora of pre-clinical efficacy and safety GLP work and of course GMP manufacturing of products, but one blog-topic at a time, right?!).

VICH GCP or Veterinary International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Good Clinical Practice (GCP), is a guideline designed to ensure the quality, safety, and efficacy of veterinary medicinal products. The VICH Good Clinical Practice (GCP) guideline, known as VICH GL9, was first issued in June 2000 and became effective in July 2001.This guideline was developed to harmonise the design and conduct of clinical studies for veterinary products across different regions, including the EU, Japan, USA as well as other interested countries.

The VICH?

“VICH” is an international program that brings together regulatory authorities to develop harmonised (standardised) requirements for the registration of veterinary medicinal products.

The GCP?

“GCP” specifically focuses on the conduct of clinical trials across different regions, thereby facilitating the mutual acceptance of clinical trial data by participating regulatory authorities.

This harmonisation aims to reduce the need for duplicative studies, streamline the drug development process, and ultimately lead to more efficient global regulatory decision-making.

As a rule all pivitol clinical studies are performed to VICH GCP.

Human vs Veterinary? ICH-GCP vs. VICH GCP?

Just in case there is confusion, the VICH GCP guideline is based on the principles of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) GCP, which are widely recognised and adopted in the human pharmaceutical industry.

However, VICH GCP is tailored to address the unique aspects of veterinary medicine, including animal welfare, species differences, and the diversity of conditions and practices in veterinary clinical settings.

Why Control Drug Development?

Protect Public Health and Safety: Early in the 20th century, the unregulated sale of drugs led to widespread health issues and fatalities. For example, the Thalidomide scandal in the 1960s, where a drug caused severe birth defects, highlighted the need for stringent regulations.

Ensure Efficacy and Quality: To ensure that drugs are effective and of high quality, regulations were introduced. This includes rigorous testing and clinical trials before a drug can be approved for use.

Prevent Abuse and Misuse: The rise in drug abuse and addiction led to laws controlling the distribution and prescription of certain substances.

Consider Economic and Ethical Concerns: Controlling drug development also helps prevent unethical practices by pharmaceutical companies, ensuring that they do not exploit consumers or engage in fraudulent activities.

Concluding Remark

By adhering to VICH GCP, the veterinary pharmaceutical industry and regulatory bodies can ensure that the data generated from clinical trials are reliable and that the rights, safety, and welfare of the animals involved are protected. This is crucial for the development of safe and effective veterinary medicines that contribute to public health and the well-being of animals.

Further reading:

Human ICH GCP

ICH E6 (R2) Good clinical practice - Scientific guideline | European Medicines Agency (EMA) (europa.eu)

Veterinary VICH GCP (EU)

VICH Topic GL9 (GCP) (europa.eu)

Veterinary VICH GCP (US)

GFI #85 - VICH GL9 (GCP) (fda.gov)

Veterinary VICH GCP (Japan)

https://www.maff.go.jp/nval/english/regulatory/pdf/Outline_RegulatorySystem_VMPs.pdf

Heading off to the RQA conference, Nov 2024

Sun, 06 Oct 2024 07:57:19 GMT

Excited to be helping my colleagues with a workshop on "deviations". Also looking forward to hearing experiences of FDA-inspections in the EU. Another hot topic!