How long is an ofsted monitoring visit

The signed checklist can be uploaded into an app, as it will only contain subject initials, screening number, and site number. The EMA released guidance for remote monitoring on data protection, monitor responsibilities, subject confidentiality, etc. Quanticate offers Data Quality Oversight DQO of site data which uses statistical analytics to generate reports to improve data integrity as outliers and data anomalies are discovered.

DQO can be applied to any clinical monitoring method. Quanticate can also provide consultancy around rSDV and methodologies to conduct centralized remote monitoring and centralized statistical monitoring. Schedule a consultation if you would like to hear how we could improve data quality or monitoring efficiency and a member of our team will be in touch with you shortly.

We aim to provide information and support written by our experienced staff. We want to share our knowledge and create an archive of information that you will be able to engage with, share and comment on. Contact Submit RFI. Who are we? Quanticate CRO Blog. Video review of records; site staff sharing their computer screen using a secure video conference application.

Centralized Monitoring Once a single centralized team is responsible for the SDV and the Data Quality Oversight, it becomes possible to identify trends and potential problems that go beyond transcription problems from source documents. A monitoring risk assessment is required to ensure: Adequate protection of the rights, welfare and safety of the subjects.

Over the coming weeks, Pharm-Olam will take a deeper dive into the different clinical trial monitoring techniques and the technologies used to support them. As we release these updates, we will add links here to their location on our blog for ease of navigation and discovery. We hope you find these articles interesting and beneficial to your efforts in protecting data quality and patient safety in your clinical trials.

Pharm-Olam, as a global award-winning CRO, is dedicated to creating a healthier world for all. Stay tuned for future updates in this series! Download this ebook to learn the formula for success when conducting rare disease clinical trials. Related Articles. Respiratory Viral Infections: Progress and Innovation. What it expects from researchers and the sponsors is methodologies which ensure data quality.

How the industry does it is open to innovation and application of statistical methods, targeted and remote monitoring, real time reporting, adaptive monitoring schedules, etc. In short, hybrid approaches to monitoring. Coupled with concepts of optimum monitoring and SDV at site and off-site monitoring techniques, it should be possible to save time required to conduct SDV leading to more available time for other productive activities. Whether it also affects the work-life balance of monitors who may then need to travel with a less hectic schedule for the same level of quality and productivity can be predicted only when there is more evidence from field.

The definition above is a well-rounded one; however it does not mandate any specifics of how much or how little monitoring would ensure quality, nor does it say how and when to conduct visits. The global definition also affirms that the specifics of how and when to conduct monitoring and hence SDV should be laid down on a case-to-case basis depending on several criteria. Section 5. The sponsor should determine the appropriate extent and nature of monitoring.

The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size and endpoints of the trial. Statistically controlled sampling may be an acceptable method for selecting the data to be verified. The focus is still on catching the mistakes rather than preventing them from happening.

Since, prevention is proactive, it need not happen at the site or during the monitoring visit. It can be a continuous process even before a site visit has started. The temptation of reviewing all the data also means that the time that should be spent on the critical data points such as inclusion-exclusion criteria, primary secondary endpoints, informed consent, etc.

It has been largely believed that more SDV means better quality and since none of the current regulations speak explicitly and quantitatively about the nature and extent of monitoring activities, researchers, and monitors err on the side of caution.

Perhaps the regulators realize that although driven by the same overarching concepts of GCP, all clinical trials are different in terms of operational conduct and intended outcome.

Within the ambit of the set guidelines, the conduct including nature and extent of SDV of the trial is largely left to the sponsors, so that there is scope of flexibility and innovation in how monitoring is done. This means that the preparation of monitoring and the actual act of monitoring can begin and happen at any point of the trial value chain.

We can thus broadly classify study monitoring into the following three categories:[ 4 , 5 ]. The subtypes largely represent the different phases when these committees are applicable, e. DMC is an independent committee which is active during the entire data acquisition phase and is responsible for ensuring that the emergent data are reviewed and meaningful conclusions about continuation of the study on grounds of safety and efficacy may be drawn [ Table 1 ]. Different types of monitoring committees, their composition and responsibilities across various phases of study conduct.

Think of it as central lab versus local lab assessment of protocol required lab tests. Similar to central labs, central monitoring techniques have several advantages. It allows a view of all the sites in a trial almost on a real time basis.

The assessment of the trial parameters scientific as well as procedural are done consistently as it is done centrally. This can help in spotting trends in some of the parameters and can set off a trial level or site level remedial action. Knowing that remote clinical trial monitoring is here to stay and both sites and sponsors need a solution in place, the question becomes: is your research site equipped to participate in this transformation?

There are four ways to ensure your research site is equipped for remote clinical trial monitoring:. The first path is one many research sites are familiar with: a sponsor-driven and sponsor-deployed technology. The second path has emerged over the past four years as sites have built out their infrastructure: a site-procured and site-maintained remote clinical trial monitoring and eISF solution. The industry is shifting to path 2 site-procured , but some sites are not ready to pursue this step.

As we look at both paths, we will identify specific solutions associated with each and the benefits of those solutions. We will also explore how in Path 1 sponsors have a new solution available to deploy to research sites that takes a fresh approach to what sponsors have always done historically, and that is putting the research site at the forefront of the technology. If you are a research site, you have a choice to agree to use a sponsor-deployed solution. Will this solution integrate with existing established site workflows?

Integration with your established site workflows ensures you are not in conflict with your organizational-wide processes. Will you own the data and documents? Will this solution help you do that? What about the data flowing through it? Is that data owned by the site or the sponsor?

Do you as the site control access and permissions? Monitors should only see certain documents and sources during certain times. Are you able to easily control that? Will the solution vendor help us be successful? Training and ongoing support are essential to set sites up for success. Are you expected to learn the solution yourself or will the vendor provide training to help you get started?

Will the solution provide ongoing support throughout the life of the study? Replicating efficient processes and workflows saves time. Does the solution focus on the success of the research site?