RBQM Ops 2022 - How is monitoring driven by data source and collection?

How is monitoring driven by data source and collection?

SUMMARY KEYWORDS
central monitoring, clinical trials, data, trial, risk, quality, organisation, site, gcp, conduct, patient, objectives, approach, processes, ich e6(r2), revision, study, clinical

SPEAKER
Dr Hanna Preus, Global Director of Clinical Quality Assurance, Process Excellence, and Quality Analytics at Astellas Pharma

Thank you for the introduction and hello, everyone. It's a pleasure for me to be here today.

During this session, we will talk about clinical trial monitoring, and how is monitoring driven by data source and collection. This presentation has been created with the use of knowledge and experience acquired in both pharma and CRO organisation and does not represent an official policy or position of any specific organisation.

Clinical trials are becoming increasingly complex, particularly with complicated design, global teams, and diverse data sources. Let's start with the definition. In ICH E6(R2) good clinical practice guideline, monitoring is defined as the act of overseeing the progress of a clinical trial and ensuring that it is conducted recorded and reported in accordance with the protocol standard operating procedures, good clinical practice and the applicable regulatory requirements.

There are listed here key elements important when we are talking about monitoring clinical trials, monitoring strategy that should be developed at the early stage of clinical trials monitoring plan that should be tailored to the specific clinical project and potential risks of the trial.

As we are talking about monitoring, the plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for the use. The plan should also emphasize the monitoring of critical data and processes.

Monitoring Conduct. That is described in detail in GCP Chapter 5.18, title “Monitoring” where you can find more information about the monitors qualifications and responsibilities, monitoring procedures, and the necessity to determine the appropriate the extent and nature of monitoring taking into consideration the aspect such as the clinical trial objective, design, complexity, size, endpoints of the trial, etc.