Blog article

How to generate sdtm datasets?

Data export in SDTM format: with pleasure and without unnecessary worries

SDTM (Study Data Tabulation Model) data export provides a consistent view of data and allows you to analyze data from multiple studies, including clinical trials. As a rule, the provision of data in the SDTM format is compulsory for filing with regulatory authorities, for example, the FDA (Food and Drug Administration).

Many people face difficulties when trying to generate sdtm datasets. Although their Electronic Data Capture systems host project-specific eIRC (Electronic Individual Registration Card) forms. Uploading data is not always easy, as not all systems allow data to be exported directly to SDTM. format. To resolve this issue, you should require additional time and effort to find a suitable service that can solve this issue.

When we are talking about how to generate sdtm datasets using software from a certified company, the company is required to timely and carefully control the data generated during the research process. There are many reasons why a domain upload may be required at any time.

Why do you need to export the clinical data in this precise format

So, exporting data in SDTM format is necessary not only at meetings to discuss data and meetings of the Independent Data and Safety Monitoring Board. At any time, it may be necessary to check all adverse and serious events listed in the eRCF, their medical codes, or clinically significant abnormalities in laboratory tests; all visits of a particular patient in one file to ensure that all study subjects meet the inclusion criteria described in the protocol, etc.

Using proven clinical trial software, you retain full control over the study without the need to attract additional time and financial resources to work with data. Specialists provide support in setting up eIRK and in working with domain uploads.

Users who do not have technical training can work with domain uploading since the data is presented in a format that is understandable for perception.

By getting an SDTM datasets export configuration adapted to your request, you will forget about unexpected budget approvals, unexpected work with contracts and additional agreements.

You will be able to effectively work with data in the SDTM format in the production environment.

How to generate sdtm datasets?

When talking about reliable clinical software, once you pass the acceptance test, you will be able to download real-time data whenever you need it. Availability of downloads 24/7 will help control the progress of a clinical trial and provide transparency and control of the history of downloads given in the project as of a specific time and date.

A distinctive feature of the SDTM datasets export done using reliable clinical software is that despite a large amount of data, the upload occurs in the background and does not affect the current session or the work of other users. As soon as the data is ready, you will receive a notification in the browser (if you are still logged in) and an email indicating that the upload is ready.