Risk Based Quality Management (RBQM) on Increased Fragmentation of Data Collection

Data Fragmentation:

Data fragmentation refers to the dispersion of an organization's data assets. As you collect more data from multiple sources and store it in more locations, the likelihood of data dispersal increases. This is primarily due to the formation of technology silos and the dispersion of data can be divided into three distinct bits - Vertical, horizontal, mixed or hybrid fragmentation.

?Risk Based Quality Management (RBQM):

A plan of action is required to process and manage requirements efficiently. Before escalation, a risk-based quality management approach helps with risk identification, collection, and management. RBM techniques monitor risk and aid in analytical thought and decision-making using software, data inputs, and analytics. RBM can increase data quality, increase patient safety, and save costs by enabling sponsors to spot and address problems as they happen. Based on the nature of the requirement and the resources at your disposal, the risk-based quality management method assists you in determining the appropriate amount of testing for each requirement. After that, you can structure your testing procedure around these suggestions.

Customized RBQM:

In the current era of technology adoption in trial conduct. Effective implementation of RBQM process is vital hence the regulations require sponsors to monitor the conduct and progress of their clinical investigations. Therefore, a range of approaches to trial monitoring are compatible with the regulations.

Following are the factors to consider for the monitoring plan and activities.

·??????Complexity of the study design where data is received via multiple sources

·??????Types of study endpoints

·??????Clinical complexity of the study population - multi centric/global sites

·??????Geographic location of clinical investigator (CI)/sites

·??????Electronic data capture to be utilized – versatile and open to connect to receive external data from other sources

·??????Relative safety of the investigational product – shipping and storing of IP

·??????Quantity of data – storing and processing of patient data on real time basis

Here are some of the benefits of a customized RBQM

●?????Simplified compliance

●?????Better operational efficiency

●?????Improved awareness of quality risk

●?????Leads to better decision-making

●?????Documentation of Risk Management Thorough Risk reporting.

?RBQM on Increased Data Fragmentation:

We can study the risk, analyze it, and manage it appropriately by adapting customized RBQM strategy. Customizing RBQM streamlines the procedure and enables us to concentrate on the core issue.

Problems caused by data fragmentation can be solved by organizing the data infrastructure, removing duplicate data, and optimizing cloud usage. Reduced data fragmentation will save resources, make information more accessible, and increase processing speed.

Following is link of guidance document shared, for further references.

https://www.fda.gov/media/121479/download

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