Precise data drives excellence

How to optimise your data management with minimal effort

Nothing is as crucial in a clinical trial as ensuring high-quality and valid data – after all, data is the key to a successful (and speedy) approval process.

However, the multiple data sources you collect from the laboratory and from tests during a clinical trial can challenge the data validation and reconciliation phase.

Because the more data sources you have to handle, the more time-consuming it will be to ensure that all data sources consistently use critical identifiers. This is vital as differences in patient ID, visit ID, measurement ID, date and time point can compromise your data interpretation and analysis.

In this blog post, we will go through some of the biggest challenges to ensure an efficient data cleaning and reconciliation process.

Make sure everyone is on the same page – and stay there

Nothing can cause havoc in data management like a lack of structure. 

So, setting up your eCRF should be a top priority. This provides you with a structured tool to collect, record and manage your various data sources in a standardised manner. In other words, it creates a foundation to collect valid, high-quality data in your clinical trials.

Here, it is important to take the time to provide clear and comprehensive descriptions of the different variables in order to reduce ambiguity and errors throughout the research process.

However, setting up your eCRF or defining your variables is not enough. 

All stakeholders should be in alignment and stick to the agreed structure. Otherwise, your work with setting up a proper structure will be a wasted effort, and it will become difficult to protect your data integrity or uphold standardised and consistent naming conventions, data formats and proper mapping of identifiers like patient ID, visit ID, Measurement ID, date and time point.

Test the accuracy with test transfers

There is no need to wait and jeopardise issues or discrepancies at the end of the clinical trial. 

Instead, run test transfers to verify that your data transfers seamlessly between the different systems or among involved stakeholders. 

This is crucial in order to improve the likelihood of early detection and to correct potential issues or errors in data formatting, mapping or transfer protocols in order to avoid data corruption or costly delays.

Make life easier by choosing standardised file formats

Another strategy to ensure consistent and valid data is choosing widely compatible file formats like SAS transport datasets or .csv files, which greatly improves the smoothness of transferring data between different IT systems. 

These formats reduce the complications that may arise from using Excel files, which can be problematic in terms of changes in formatting between transfers.

While discussing difficulties with managing various data sets – and how to solve these – it is important to mention the benefits of ensuring a unique link between your eCRF data and the external data sets. 

Without a link, you risk discrepancies in visit names, missing accession numbers or variations in subject numbers or parameter names that can lead to errors in data interpretation.

Consider what will be the right lab for you

Your lab can greatly impact a clinical trial, including the data integrity.

One of the vital choices will be the decision to use a local lab or a central lab. While a local lab offers certain benefits such as proximity, accessibility and the ability to perform specific measurements, it can also pose certain challenges and take up a lot of your resources to oversee data uniformity and ensure standardised data.

Employing a lab module in the eCRF is one way to streamline the handling of lab measurements, thereby ensuring alignment between the units recorded. However, always keep an eye on the lab during the trial as laboratories might modify their reference ranges, meaning you will have to ensure that these changes are also propagated to the relevant parties regularly.

In the end, the success of your clinical trial hinges on your data, and a structured and streamlined approach to data handling can help you avoid draining your resources and achieve a speedy validation process.

BioStata is your professional clinical research organisation

At BioStata, we help sponsors keep their clinical trials on track with high-quality data.

We offer a wide range of clinical data management services, including protocol review, eCRF in Viedoc or Zelta, data management plans, external data transfer specifications and much more.

Are you looking for assistance with a clinical trial? We are happy to help you find a solution that suits your needs.

Let us discuss your data

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