Monitoring

Our comprehensive monitoring services encompass protocol quality control, site screening, study set-up, user acceptance testing, real-time oversight, and study close-out, ensuring adherence to VICH GCP standards and seamless conduct of veterinary clinical studies.

OUR MINDSET

Monitoring

Monitors of a veterinary clinical study adhering to VICH GCP play a critical role in ensuring the integrity, quality, and ethical conduct of the study. Having a good monitor on a clinical study is crucial to the success of the study.

Our services include: Provision of a Lead Monitor, Protocol Quality Control, Site Screening & Investigator/Third Party Qualification, Study Set-Up, User Acceptance Testing, Study In-Phase Oversight, Study Close-Out.

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Provision of a Lead Monitor

Provision of a Lead Monitor to manage a designated team of monitors, providing consistency of monitoring across sites/countries and providing centralised and regular update to the Sponsor.

Protocol Quality Control

Protocol quality control, VICH GCP compliance and peer review. With numerous studies performed in a range of species, countries and veterinary medicinal products, the VICH GCP consultancy is well placed to practically review and critique a study protocol to ensure it is fit for purpose and in compliance with regulatory requirements.

Site Screening & Investigator/Third Party Qualification

Site screening and Investigator/Third Party Qualification, to determine site suitability and potential case load. The VICH GCP Consultancy has an established network of Investigator sites with experience and training in VICH GCP, this working relationship guarantees ease of communication throughout the study period to ensure the success of the project.

Study Set-Up

Study Set-up, includes training (in the study protocol, VICH GCP and Good Documentation Practice), supply of clinical study files and study materials to each site prior to the start of a study.

User Acceptance Testing

User acceptance testing of electronic data capture systems by challenging the system's functionality, usability, and overall performance to ensure that it meets the needs and expectations of end-users.

Study In-Phase Oversight

Study In-phase oversight, visits to sites and real-time data monitoring (raw data verification and data validation) throughout the study to ensure that all procedures are conducted in accordance with the approved protocol, amendments, Standard Operating Procedures (SOPs) and applicable regulations. Monitor study progress and compliance, review study documents, and report any deviations, adverse events, discrepancies, or concerns to the sponsor.

Study Close-Out

Study Close-out, data validation, final IVP/CVP/CP accountability and reconciliation at the end of the study to ensure that all study procedures are completed, study documentation is prepared for archive appropriately, and that the final report author has everything required to prepare the final study report.

Example of Monitoring

Ensuring Precision and Compliance

Whilst some clients prefer The VICH GCP Consultancy to operate according to the Sponsor’s own Standard Operating Procedures, a Study Monitoring Plan is typically developed for projects. This is a document which states the monitoring responsibilities for the study as well as the critical data verification and validation points for monitor checking during the study period. Each monitoring plan is tailored specifically to the project. So, for example, if the Sponsor wanted a more “risk-based monitoring” approach this would be fully described in the monitoring plan and would detail the percentage check for each data set.

Click below to download the example monitoring plan and explanatory notes, including the data verification checks for an example study.